Richard Mark Kirkner

BALTIMORE — A 2910-nm erbium-doped fluoride glass fiber laser, approved 2 years ago by the US Food and Drug Administration (FDA), has demonstrated a high degree of improvement for facial photoaging and rhytides along with relatively high rates of patient satisfaction — while causing less discomfort and downtime compared with conventional fractional lasers, a small single-center study showed.

The study enrolled 15 patients who had three treatment sessions with the 2910-nm laser. “It’s highly customizable,” the study’s lead author, Taryn Murray, MD, a dermatologist at Cleveland Clinic, told this news organization. “It has a really fast time in healing compared to traditional abatable lasers; the healing time is 5-7 days vs several weeks.” Dr. Murray presented the results at the annual meeting of the American Society for Laser Medicine and Surgery (ASLMS).
 

The Technology Behind the Laser

The 2910-nm erbium-doped fluoride glass fiber laser is a mid-infrared ablative fractional device that operates at peak water absorption. It’s designed to cause minimal residual thermal damage, resulting in less discomfort, shorter downtime, and potentially fewer side effects than conventional ablative lasers, Dr. Murray said.

Murray_Taryn_Ohio_web.jpg

Because of the way the pulses are delivered, “it’s far less painful than traditional fractional ablative lasers, so you can use mainly topical numbing; you don’t need nerve blocks, you don’t have to infiltrate lidocaine, you don’t have to put the patient under anesthesia,” she said.

“Because of the wavelength, how pulses are delivered and how customizable the settings are, it’s safer to use in darker skin types,” and the density, depth, and the amount of coagulation applied into the skin are customizable, Dr. Murray added. 

The laser also delivers pulses in a different way than the conventional 2940-nm erbium and CO₂ lasers, she explained. “Traditional lasers do it all in one pulse. This laser uses micropulses with relaxation time in between pulses, so the body interprets it as less painful and allows pressure and steam to escape out of the channel, which results in faster healing.”

[embed:render:related:node:265602]

The study patients had topical anesthetic cream applied to their faces 45-60 minutes before the procedure. Multiple passes were made using both superficial and deep laser modes. The average patient age was 65.7 years, and Fitzpatrick skin types included I (n = 3), II (n = 3), III (n = 7), and IV (n = 2). On a scale of 0-10, the average level of discomfort was 4.9, and the average patient satisfaction after three treatments was 4.8, Dr. Murray said.

For cosmetic improvement, the study used the 5-point Global Aesthetic Improvement Scale (GAIS). Blinded reviewers evaluated digital images and determined an average GAIS score of 3.2 for overall appearance, 2.9 for wrinkles, 3.6 for pigment, 3.1 for skin texture, and 2.6 for skin laxity. 

When the patients themselves reviewed the digital images, the average GAIS score was 3.8 for overall appearance. 

Side effects, said Dr. Murray, were transient, with edema and soft-tissue crusting lasting 3-5 days and erythema resolving in 1-2 weeks on average. One case of postinflammatory hyperpigmentation (PIH) did arise, which was linked to allergic contact dermatitis from the healing ointment. That patient stayed in the study and had complete resolution of the PIH.

Study Stands Out

A number of studies of the 2910-nm erbium-doped fluoride glass fiber laser have emerged over the past half year, Ritu Swali, MD, who was an American Society of Dermatologic Surgery fellow at a practice in Houston, said in an interview at the meeting. But this one stands out because of the evidence surrounding its use.

Most people are using this laser for facial resurfacing, “and we want to know that we have a technology ... with shorter downtime and easier wound care and just more comfort,” she said.

Swali_Ritu_web.jpg

A version of this article first appeared on Medscape.com.

BALTIMORE — A 2910-nm erbium-doped fluoride glass fiber laser, approved 2 years ago by the US Food and Drug Administration (FDA), has demonstrated a high degree of improvement for facial photoaging and rhytides along with relatively high rates of patient satisfaction — while causing less discomfort and downtime compared with conventional fractional lasers, a small single-center study showed.

The study enrolled 15 patients who had three treatment sessions with the 2910-nm laser. “It’s highly customizable,” the study’s lead author, Taryn Murray, MD, a dermatologist at Cleveland Clinic, told this news organization. “It has a really fast time in healing compared to traditional abatable lasers; the healing time is 5-7 days vs several weeks.” Dr. Murray presented the results at the annual meeting of the American Society for Laser Medicine and Surgery (ASLMS).
 

The Technology Behind the Laser

The 2910-nm erbium-doped fluoride glass fiber laser is a mid-infrared ablative fractional device that operates at peak water absorption. It’s designed to cause minimal residual thermal damage, resulting in less discomfort, shorter downtime, and potentially fewer side effects than conventional ablative lasers, Dr. Murray said.

Murray_Taryn_Ohio_web.jpg

Because of the way the pulses are delivered, “it’s far less painful than traditional fractional ablative lasers, so you can use mainly topical numbing; you don’t need nerve blocks, you don’t have to infiltrate lidocaine, you don’t have to put the patient under anesthesia,” she said.

“Because of the wavelength, how pulses are delivered and how customizable the settings are, it’s safer to use in darker skin types,” and the density, depth, and the amount of coagulation applied into the skin are customizable, Dr. Murray added. 

The laser also delivers pulses in a different way than the conventional 2940-nm erbium and CO₂ lasers, she explained. “Traditional lasers do it all in one pulse. This laser uses micropulses with relaxation time in between pulses, so the body interprets it as less painful and allows pressure and steam to escape out of the channel, which results in faster healing.”

[embed:render:related:node:265602]

The study patients had topical anesthetic cream applied to their faces 45-60 minutes before the procedure. Multiple passes were made using both superficial and deep laser modes. The average patient age was 65.7 years, and Fitzpatrick skin types included I (n = 3), II (n = 3), III (n = 7), and IV (n = 2). On a scale of 0-10, the average level of discomfort was 4.9, and the average patient satisfaction after three treatments was 4.8, Dr. Murray said.

For cosmetic improvement, the study used the 5-point Global Aesthetic Improvement Scale (GAIS). Blinded reviewers evaluated digital images and determined an average GAIS score of 3.2 for overall appearance, 2.9 for wrinkles, 3.6 for pigment, 3.1 for skin texture, and 2.6 for skin laxity. 

When the patients themselves reviewed the digital images, the average GAIS score was 3.8 for overall appearance. 

Side effects, said Dr. Murray, were transient, with edema and soft-tissue crusting lasting 3-5 days and erythema resolving in 1-2 weeks on average. One case of postinflammatory hyperpigmentation (PIH) did arise, which was linked to allergic contact dermatitis from the healing ointment. That patient stayed in the study and had complete resolution of the PIH.

Study Stands Out

A number of studies of the 2910-nm erbium-doped fluoride glass fiber laser have emerged over the past half year, Ritu Swali, MD, who was an American Society of Dermatologic Surgery fellow at a practice in Houston, said in an interview at the meeting. But this one stands out because of the evidence surrounding its use.

Most people are using this laser for facial resurfacing, “and we want to know that we have a technology ... with shorter downtime and easier wound care and just more comfort,” she said.

Swali_Ritu_web.jpg

A version of this article first appeared on Medscape.com.

BALTIMORE — A 2910-nm erbium-doped fluoride glass fiber laser, approved 2 years ago by the US Food and Drug Administration (FDA), has demonstrated a high degree of improvement for facial photoaging and rhytides along with relatively high rates of patient satisfaction — while causing less discomfort and downtime compared with conventional fractional lasers, a small single-center study showed.

The study enrolled 15 patients who had three treatment sessions with the 2910-nm laser. “It’s highly customizable,” the study’s lead author, Taryn Murray, MD, a dermatologist at Cleveland Clinic, told this news organization. “It has a really fast time in healing compared to traditional abatable lasers; the healing time is 5-7 days vs several weeks.” Dr. Murray presented the results at the annual meeting of the American Society for Laser Medicine and Surgery (ASLMS).
 

The Technology Behind the Laser

The 2910-nm erbium-doped fluoride glass fiber laser is a mid-infrared ablative fractional device that operates at peak water absorption. It’s designed to cause minimal residual thermal damage, resulting in less discomfort, shorter downtime, and potentially fewer side effects than conventional ablative lasers, Dr. Murray said.

Murray_Taryn_Ohio_web.jpg

Because of the way the pulses are delivered, “it’s far less painful than traditional fractional ablative lasers, so you can use mainly topical numbing; you don’t need nerve blocks, you don’t have to infiltrate lidocaine, you don’t have to put the patient under anesthesia,” she said.

“Because of the wavelength, how pulses are delivered and how customizable the settings are, it’s safer to use in darker skin types,” and the density, depth, and the amount of coagulation applied into the skin are customizable, Dr. Murray added. 

The laser also delivers pulses in a different way than the conventional 2940-nm erbium and CO₂ lasers, she explained. “Traditional lasers do it all in one pulse. This laser uses micropulses with relaxation time in between pulses, so the body interprets it as less painful and allows pressure and steam to escape out of the channel, which results in faster healing.”

[embed:render:related:node:265602]

The study patients had topical anesthetic cream applied to their faces 45-60 minutes before the procedure. Multiple passes were made using both superficial and deep laser modes. The average patient age was 65.7 years, and Fitzpatrick skin types included I (n = 3), II (n = 3), III (n = 7), and IV (n = 2). On a scale of 0-10, the average level of discomfort was 4.9, and the average patient satisfaction after three treatments was 4.8, Dr. Murray said.

For cosmetic improvement, the study used the 5-point Global Aesthetic Improvement Scale (GAIS). Blinded reviewers evaluated digital images and determined an average GAIS score of 3.2 for overall appearance, 2.9 for wrinkles, 3.6 for pigment, 3.1 for skin texture, and 2.6 for skin laxity. 

When the patients themselves reviewed the digital images, the average GAIS score was 3.8 for overall appearance. 

Side effects, said Dr. Murray, were transient, with edema and soft-tissue crusting lasting 3-5 days and erythema resolving in 1-2 weeks on average. One case of postinflammatory hyperpigmentation (PIH) did arise, which was linked to allergic contact dermatitis from the healing ointment. That patient stayed in the study and had complete resolution of the PIH.

Study Stands Out

A number of studies of the 2910-nm erbium-doped fluoride glass fiber laser have emerged over the past half year, Ritu Swali, MD, who was an American Society of Dermatologic Surgery fellow at a practice in Houston, said in an interview at the meeting. But this one stands out because of the evidence surrounding its use.

Most people are using this laser for facial resurfacing, “and we want to know that we have a technology ... with shorter downtime and easier wound care and just more comfort,” she said.

Swali_Ritu_web.jpg

A version of this article first appeared on Medscape.com.

BALTIMORE — A relatively new registry of complications from dermatologic surgery has posted its first results, showing that among laser and energy device treatments, the most common adverse events (AEs) were blistering, hypopigmentation, scars, and burns. But the process of reporting AEs to the registry needs to be made easier to attract more cases and provide a more complete picture of complications after dermatologic procedures, a researcher and observer said.

The Cutaneous Procedures Adverse Events Reporting Registry (CAPER) was established in 2021 to track AEs from dermatologic procedures. Since then, it has logged a total of 81 cases and 147 AEs from 27 unique procedures, Eric Koza, MD, a postdoctoral research fellow in the Department of Dermatology at Northwestern University, Chicago, reported at the annual conference of the American Society for Laser Medicine and Surgery.

Koza_Eric_Illinois_web.jpg

“The takeaways from this project is that 20 laser and energy device treatments have been reported to the registry, half of which were nonablative laser treatments,” Dr. Koza said in presenting the results. “Of the adverse events reported, nonphysicians and non-dermatologic physicians were more likely to be associated with severe or persistent adverse events.”

[embed:render:related:node:262554]

The American Society for Dermatologic Surgery Association and the Northwestern University Department of Dermatology launched CAPER. Previously, Dr. Koza said, AEs were typically reported only through the Food and Drug Administration’s AE reporting system. He noted that CAPER is the only voluntary national reporting registry for AEs from dermatologic procedures.

What the Registry Shows So Far

The registry matched 72 of the 81 cases with type of provider, with dermatologist-conducted procedures (51, 70.8%) comprising the majority, followed by nonphysician-conducted procedures (14, 19.4%) and nondermatologist physician–conducted procedures (7, 9.7%).

Of the 81 total cases, the following reports were related to laser and energy device treatments: 12 (14.3%) from nonablative laser treatments, five (6%) from light treatments, and three (3.6%) from ablative laser treatments, Dr. Koza said.

Among nonablative laser treatments, the most common AE was blistering (six reports, 50%). Scar, pain, and hypopigmentation accounted for two cases each (16.67%). Dermatologists performed seven of these cases (58.3%); nonphysicians, four (33.3%); and a non-dermatologist physician, one (8.3%).

For intense pulsed-light treatments, burns were the most common AEs (three reports, 60%), with swelling and inflammation each accounting for one case (20%). Three of these cases (75%) were confirmed to have been performed by nonphysicians.

The ablative laser treatment AEs included one case each of hypopigmentation, scar, and erythema. Two of the three cases were confirmed to have been performed by dermatologists.

Dr. Koza acknowledged the low number of cases is a limitation of this analysis of registry reports. A future goal for CAPER is to publicize it more, he said. “The registry is only 3 years old,” he told this news organization. “Hopefully, we can get more data as time goes on. We’ve been getting more and more each year.” CAPER adapted data entry forms used in other registries.

Submitting a case to the registry takes about 15 minutes of the provider’s time, Dr. Koza said. “We can streamline that to make it easier for people to submit their adverse events,” he said in an interview.

Only registry staff have access to the reports, and when reported, the data “is de-identified and any identifying information pertaining to the patient or reporter is removed,” according to a statement on the CAPER website.
 

‘Needs a Little Help’

Jennifer Lin, MD, a dermatologist at Brigham and Women’s Hospital and Dana-Farber Cancer Institute in Boston, who was at the meeting, commented on the onerous reporting process and the “low” enrollment. “It’s such an important initiative and with everyone over-logging e-mails, a 15-minute entry just is not going to cut it,” she told this news organization.

For providers, reporting AEs is stressful, she said. “As it is, it’s hard to voluntarily submit an adverse event,” Dr. Lin continued. “There’s a feeling of shame. Hospitals require it in order to monitor adverse events, but there’s no monitoring when you’re out in your own private practice.”

“The idea is excellent, but I think to facilitate better enrollment, the word has to get out at all these meetings” and make it easier to submit cases, Dr. Lin added. “It’s a good idea, but it needs a little help.”

Information on submitting AE reports to CAPER is available on the CAPER website.

Dr. Koza and Dr. Lin had no relevant relationships to disclose.

A version of this article first appeared on Medscape.com.

BALTIMORE — A relatively new registry of complications from dermatologic surgery has posted its first results, showing that among laser and energy device treatments, the most common adverse events (AEs) were blistering, hypopigmentation, scars, and burns. But the process of reporting AEs to the registry needs to be made easier to attract more cases and provide a more complete picture of complications after dermatologic procedures, a researcher and observer said.

The Cutaneous Procedures Adverse Events Reporting Registry (CAPER) was established in 2021 to track AEs from dermatologic procedures. Since then, it has logged a total of 81 cases and 147 AEs from 27 unique procedures, Eric Koza, MD, a postdoctoral research fellow in the Department of Dermatology at Northwestern University, Chicago, reported at the annual conference of the American Society for Laser Medicine and Surgery.

Koza_Eric_Illinois_web.jpg

“The takeaways from this project is that 20 laser and energy device treatments have been reported to the registry, half of which were nonablative laser treatments,” Dr. Koza said in presenting the results. “Of the adverse events reported, nonphysicians and non-dermatologic physicians were more likely to be associated with severe or persistent adverse events.”

[embed:render:related:node:262554]

The American Society for Dermatologic Surgery Association and the Northwestern University Department of Dermatology launched CAPER. Previously, Dr. Koza said, AEs were typically reported only through the Food and Drug Administration’s AE reporting system. He noted that CAPER is the only voluntary national reporting registry for AEs from dermatologic procedures.

What the Registry Shows So Far

The registry matched 72 of the 81 cases with type of provider, with dermatologist-conducted procedures (51, 70.8%) comprising the majority, followed by nonphysician-conducted procedures (14, 19.4%) and nondermatologist physician–conducted procedures (7, 9.7%).

Of the 81 total cases, the following reports were related to laser and energy device treatments: 12 (14.3%) from nonablative laser treatments, five (6%) from light treatments, and three (3.6%) from ablative laser treatments, Dr. Koza said.

Among nonablative laser treatments, the most common AE was blistering (six reports, 50%). Scar, pain, and hypopigmentation accounted for two cases each (16.67%). Dermatologists performed seven of these cases (58.3%); nonphysicians, four (33.3%); and a non-dermatologist physician, one (8.3%).

For intense pulsed-light treatments, burns were the most common AEs (three reports, 60%), with swelling and inflammation each accounting for one case (20%). Three of these cases (75%) were confirmed to have been performed by nonphysicians.

The ablative laser treatment AEs included one case each of hypopigmentation, scar, and erythema. Two of the three cases were confirmed to have been performed by dermatologists.

Dr. Koza acknowledged the low number of cases is a limitation of this analysis of registry reports. A future goal for CAPER is to publicize it more, he said. “The registry is only 3 years old,” he told this news organization. “Hopefully, we can get more data as time goes on. We’ve been getting more and more each year.” CAPER adapted data entry forms used in other registries.

Submitting a case to the registry takes about 15 minutes of the provider’s time, Dr. Koza said. “We can streamline that to make it easier for people to submit their adverse events,” he said in an interview.

Only registry staff have access to the reports, and when reported, the data “is de-identified and any identifying information pertaining to the patient or reporter is removed,” according to a statement on the CAPER website.
 

‘Needs a Little Help’

Jennifer Lin, MD, a dermatologist at Brigham and Women’s Hospital and Dana-Farber Cancer Institute in Boston, who was at the meeting, commented on the onerous reporting process and the “low” enrollment. “It’s such an important initiative and with everyone over-logging e-mails, a 15-minute entry just is not going to cut it,” she told this news organization.

For providers, reporting AEs is stressful, she said. “As it is, it’s hard to voluntarily submit an adverse event,” Dr. Lin continued. “There’s a feeling of shame. Hospitals require it in order to monitor adverse events, but there’s no monitoring when you’re out in your own private practice.”

“The idea is excellent, but I think to facilitate better enrollment, the word has to get out at all these meetings” and make it easier to submit cases, Dr. Lin added. “It’s a good idea, but it needs a little help.”

Information on submitting AE reports to CAPER is available on the CAPER website.

Dr. Koza and Dr. Lin had no relevant relationships to disclose.

A version of this article first appeared on Medscape.com.

BALTIMORE — A relatively new registry of complications from dermatologic surgery has posted its first results, showing that among laser and energy device treatments, the most common adverse events (AEs) were blistering, hypopigmentation, scars, and burns. But the process of reporting AEs to the registry needs to be made easier to attract more cases and provide a more complete picture of complications after dermatologic procedures, a researcher and observer said.

The Cutaneous Procedures Adverse Events Reporting Registry (CAPER) was established in 2021 to track AEs from dermatologic procedures. Since then, it has logged a total of 81 cases and 147 AEs from 27 unique procedures, Eric Koza, MD, a postdoctoral research fellow in the Department of Dermatology at Northwestern University, Chicago, reported at the annual conference of the American Society for Laser Medicine and Surgery.

Koza_Eric_Illinois_web.jpg

“The takeaways from this project is that 20 laser and energy device treatments have been reported to the registry, half of which were nonablative laser treatments,” Dr. Koza said in presenting the results. “Of the adverse events reported, nonphysicians and non-dermatologic physicians were more likely to be associated with severe or persistent adverse events.”

[embed:render:related:node:262554]

The American Society for Dermatologic Surgery Association and the Northwestern University Department of Dermatology launched CAPER. Previously, Dr. Koza said, AEs were typically reported only through the Food and Drug Administration’s AE reporting system. He noted that CAPER is the only voluntary national reporting registry for AEs from dermatologic procedures.

What the Registry Shows So Far

The registry matched 72 of the 81 cases with type of provider, with dermatologist-conducted procedures (51, 70.8%) comprising the majority, followed by nonphysician-conducted procedures (14, 19.4%) and nondermatologist physician–conducted procedures (7, 9.7%).

Of the 81 total cases, the following reports were related to laser and energy device treatments: 12 (14.3%) from nonablative laser treatments, five (6%) from light treatments, and three (3.6%) from ablative laser treatments, Dr. Koza said.

Among nonablative laser treatments, the most common AE was blistering (six reports, 50%). Scar, pain, and hypopigmentation accounted for two cases each (16.67%). Dermatologists performed seven of these cases (58.3%); nonphysicians, four (33.3%); and a non-dermatologist physician, one (8.3%).

For intense pulsed-light treatments, burns were the most common AEs (three reports, 60%), with swelling and inflammation each accounting for one case (20%). Three of these cases (75%) were confirmed to have been performed by nonphysicians.

The ablative laser treatment AEs included one case each of hypopigmentation, scar, and erythema. Two of the three cases were confirmed to have been performed by dermatologists.

Dr. Koza acknowledged the low number of cases is a limitation of this analysis of registry reports. A future goal for CAPER is to publicize it more, he said. “The registry is only 3 years old,” he told this news organization. “Hopefully, we can get more data as time goes on. We’ve been getting more and more each year.” CAPER adapted data entry forms used in other registries.

Submitting a case to the registry takes about 15 minutes of the provider’s time, Dr. Koza said. “We can streamline that to make it easier for people to submit their adverse events,” he said in an interview.

Only registry staff have access to the reports, and when reported, the data “is de-identified and any identifying information pertaining to the patient or reporter is removed,” according to a statement on the CAPER website.
 

‘Needs a Little Help’

Jennifer Lin, MD, a dermatologist at Brigham and Women’s Hospital and Dana-Farber Cancer Institute in Boston, who was at the meeting, commented on the onerous reporting process and the “low” enrollment. “It’s such an important initiative and with everyone over-logging e-mails, a 15-minute entry just is not going to cut it,” she told this news organization.

For providers, reporting AEs is stressful, she said. “As it is, it’s hard to voluntarily submit an adverse event,” Dr. Lin continued. “There’s a feeling of shame. Hospitals require it in order to monitor adverse events, but there’s no monitoring when you’re out in your own private practice.”

“The idea is excellent, but I think to facilitate better enrollment, the word has to get out at all these meetings” and make it easier to submit cases, Dr. Lin added. “It’s a good idea, but it needs a little help.”

Information on submitting AE reports to CAPER is available on the CAPER website.

Dr. Koza and Dr. Lin had no relevant relationships to disclose.

A version of this article first appeared on Medscape.com.

BALTIMORE — Laser treatment for solar lentigines in individuals with darker skin types has long been associated with a higher risk of postinflammatory hyperpigmentation (PIH), but a small study in Thailand has shown the 532-nm picosecond laser with a fractional beam microlens array (MLA) had a significantly lower incidence of PIH than the full-beam treatment without MLA.

The study enrolled 27 patients with solar lentigines and Fitzpatrick skin types (FSTs) III-IV, Woraphong Manuskiatti, MD, professor of dermatology at Siriraj Hospital, Mahidol University, Bangkok, reported at the annual meeting of the American Society for Laser Medicine and Surgery. They received the fractional beam treatment on one side of the face and the full-beam on the other side. At 6 months, the incidence of PIH was about 81% lower on the fractional-beam side, Dr. Manuskiatti said.

“In the past, when we used laser to treat pigmented lesions, we used the so-called full-beam technique on the pigmented area,” Dr. Manuskiatti told this news organization. “From the study, we found that you don’t need to treat it at 100%. You can fractionally treat the pigmented lesion and get a really comparable treatment outcome and, at that reduced beam, less incidence of postinflammatory hyperpigmentation.”
 

Study Design and Results

Of the 27 patients in the study, 12 were FST III (44%), 14 were FST IV (52%), and one was FST V (4%). On the fractional-beam side, the laser was delivered through a 9-mm spot size with an average fluence of 0.47 J/cm² at a frequency of 2 Hz for a total of two passes without pulse overlapping. On the full-beam side, the laser was operated with a 4.5-mm handpiece, with fluence ranging from 0.3 to 0.7 J/cm² (using an endpoint of slight darkening of the pigmented lesion) at 2 Hz.

The patients received a single treatment and had a clinical evaluation and color reading assessments at 2 weeks, 1 month, 3 months, and 6 months after the treatment. Twenty-five patients completed the study.

The researchers found no statistically significant differences in lesional clearance between the two techniques at any of the follow-up assessments, Dr. Manuskiatti said. “This might be one of the alternative treatments of treating solar lentigines in dark-skinned patients,” he said when presenting the study results.

He reported the rates of PIH on the full-beam and fractional-beam sides, respectively, at the following intervals were: 64% and 8% at 2 weeks, 80% and 32% at 1 month, 96% and 36% at 3 months, and 88% and 16% at 6 months.

“The incidence of PIH on the full-beam side was statistically higher than that on the fractional-beam side throughout the follow-up period,” he said. Transient and mild hypopigmentation was observed in one patient (4%) on the fractional-beam side and in five (20%) on the full-beam side. Dr. Manuskiatti added that no other adverse effects were documented during the study.

“ Normally when you use laser to treat skin type I or II, you don’t have … PIH or darkening of the skin,” Dr. Manuskiatti told this news organization, “but when you have skin type III and above, you run into a really high incidence of postinflammatory hyperpigmentation — and treating that with fractional beam can lead to a reduced incidence of darkening of the skin afterward.”
 

A Lower-Cost Option

This study showed that the 532-nm picosecond laser with fractional beam MLA is a useful option for patients with darker skin types, Kelly Stankiewicz, MD, a dermatologist who practices in Park City, Utah, and moderated the session where these results were presented, told this news organization.

“The most challenging thing about treating lentigines in darker skin types is preventing potential side effects, mainly dyspigmentation,” she said after the meeting. “These side effects are, for the most part, temporary, but they can take 6-18 months to resolve, so it’s important to prevent them in the first place.”

She noted that the 532-nm and 1064-nm wavelengths are the most commonly available for picosecond lasers and that they’re easier to produce and less expensive. “There are picosecond lasers with middle wavelengths in the red light to near-infrared range (650-785 nm) that are better for darker skin types because they are more gentle yet still effective at targeting pigment, but these lasers are more expensive and less widely available,” Dr. Stankiewicz said. 

“The microlens array, used in this study with the 532-nm wavelength, is an inexpensive piece that fits at the end of the laser,” she added. “So, to have an option that turns a 532-nm laser into a safer device for the treatment of lentigines in darker skin types is very helpful.”

Dr. Manuskiatti and Dr. Stankiewicz had no relevant disclosures to report.
 

A version of this article first appeared on Medscape.com.

BALTIMORE — Laser treatment for solar lentigines in individuals with darker skin types has long been associated with a higher risk of postinflammatory hyperpigmentation (PIH), but a small study in Thailand has shown the 532-nm picosecond laser with a fractional beam microlens array (MLA) had a significantly lower incidence of PIH than the full-beam treatment without MLA.

The study enrolled 27 patients with solar lentigines and Fitzpatrick skin types (FSTs) III-IV, Woraphong Manuskiatti, MD, professor of dermatology at Siriraj Hospital, Mahidol University, Bangkok, reported at the annual meeting of the American Society for Laser Medicine and Surgery. They received the fractional beam treatment on one side of the face and the full-beam on the other side. At 6 months, the incidence of PIH was about 81% lower on the fractional-beam side, Dr. Manuskiatti said.

“In the past, when we used laser to treat pigmented lesions, we used the so-called full-beam technique on the pigmented area,” Dr. Manuskiatti told this news organization. “From the study, we found that you don’t need to treat it at 100%. You can fractionally treat the pigmented lesion and get a really comparable treatment outcome and, at that reduced beam, less incidence of postinflammatory hyperpigmentation.”
 

Study Design and Results

Of the 27 patients in the study, 12 were FST III (44%), 14 were FST IV (52%), and one was FST V (4%). On the fractional-beam side, the laser was delivered through a 9-mm spot size with an average fluence of 0.47 J/cm² at a frequency of 2 Hz for a total of two passes without pulse overlapping. On the full-beam side, the laser was operated with a 4.5-mm handpiece, with fluence ranging from 0.3 to 0.7 J/cm² (using an endpoint of slight darkening of the pigmented lesion) at 2 Hz.

The patients received a single treatment and had a clinical evaluation and color reading assessments at 2 weeks, 1 month, 3 months, and 6 months after the treatment. Twenty-five patients completed the study.

The researchers found no statistically significant differences in lesional clearance between the two techniques at any of the follow-up assessments, Dr. Manuskiatti said. “This might be one of the alternative treatments of treating solar lentigines in dark-skinned patients,” he said when presenting the study results.

He reported the rates of PIH on the full-beam and fractional-beam sides, respectively, at the following intervals were: 64% and 8% at 2 weeks, 80% and 32% at 1 month, 96% and 36% at 3 months, and 88% and 16% at 6 months.

“The incidence of PIH on the full-beam side was statistically higher than that on the fractional-beam side throughout the follow-up period,” he said. Transient and mild hypopigmentation was observed in one patient (4%) on the fractional-beam side and in five (20%) on the full-beam side. Dr. Manuskiatti added that no other adverse effects were documented during the study.

“ Normally when you use laser to treat skin type I or II, you don’t have … PIH or darkening of the skin,” Dr. Manuskiatti told this news organization, “but when you have skin type III and above, you run into a really high incidence of postinflammatory hyperpigmentation — and treating that with fractional beam can lead to a reduced incidence of darkening of the skin afterward.”
 

A Lower-Cost Option

This study showed that the 532-nm picosecond laser with fractional beam MLA is a useful option for patients with darker skin types, Kelly Stankiewicz, MD, a dermatologist who practices in Park City, Utah, and moderated the session where these results were presented, told this news organization.

“The most challenging thing about treating lentigines in darker skin types is preventing potential side effects, mainly dyspigmentation,” she said after the meeting. “These side effects are, for the most part, temporary, but they can take 6-18 months to resolve, so it’s important to prevent them in the first place.”

She noted that the 532-nm and 1064-nm wavelengths are the most commonly available for picosecond lasers and that they’re easier to produce and less expensive. “There are picosecond lasers with middle wavelengths in the red light to near-infrared range (650-785 nm) that are better for darker skin types because they are more gentle yet still effective at targeting pigment, but these lasers are more expensive and less widely available,” Dr. Stankiewicz said. 

“The microlens array, used in this study with the 532-nm wavelength, is an inexpensive piece that fits at the end of the laser,” she added. “So, to have an option that turns a 532-nm laser into a safer device for the treatment of lentigines in darker skin types is very helpful.”

Dr. Manuskiatti and Dr. Stankiewicz had no relevant disclosures to report.
 

A version of this article first appeared on Medscape.com.

BALTIMORE — Laser treatment for solar lentigines in individuals with darker skin types has long been associated with a higher risk of postinflammatory hyperpigmentation (PIH), but a small study in Thailand has shown the 532-nm picosecond laser with a fractional beam microlens array (MLA) had a significantly lower incidence of PIH than the full-beam treatment without MLA.

The study enrolled 27 patients with solar lentigines and Fitzpatrick skin types (FSTs) III-IV, Woraphong Manuskiatti, MD, professor of dermatology at Siriraj Hospital, Mahidol University, Bangkok, reported at the annual meeting of the American Society for Laser Medicine and Surgery. They received the fractional beam treatment on one side of the face and the full-beam on the other side. At 6 months, the incidence of PIH was about 81% lower on the fractional-beam side, Dr. Manuskiatti said.

“In the past, when we used laser to treat pigmented lesions, we used the so-called full-beam technique on the pigmented area,” Dr. Manuskiatti told this news organization. “From the study, we found that you don’t need to treat it at 100%. You can fractionally treat the pigmented lesion and get a really comparable treatment outcome and, at that reduced beam, less incidence of postinflammatory hyperpigmentation.”
 

Study Design and Results

Of the 27 patients in the study, 12 were FST III (44%), 14 were FST IV (52%), and one was FST V (4%). On the fractional-beam side, the laser was delivered through a 9-mm spot size with an average fluence of 0.47 J/cm² at a frequency of 2 Hz for a total of two passes without pulse overlapping. On the full-beam side, the laser was operated with a 4.5-mm handpiece, with fluence ranging from 0.3 to 0.7 J/cm² (using an endpoint of slight darkening of the pigmented lesion) at 2 Hz.

The patients received a single treatment and had a clinical evaluation and color reading assessments at 2 weeks, 1 month, 3 months, and 6 months after the treatment. Twenty-five patients completed the study.

The researchers found no statistically significant differences in lesional clearance between the two techniques at any of the follow-up assessments, Dr. Manuskiatti said. “This might be one of the alternative treatments of treating solar lentigines in dark-skinned patients,” he said when presenting the study results.

He reported the rates of PIH on the full-beam and fractional-beam sides, respectively, at the following intervals were: 64% and 8% at 2 weeks, 80% and 32% at 1 month, 96% and 36% at 3 months, and 88% and 16% at 6 months.

“The incidence of PIH on the full-beam side was statistically higher than that on the fractional-beam side throughout the follow-up period,” he said. Transient and mild hypopigmentation was observed in one patient (4%) on the fractional-beam side and in five (20%) on the full-beam side. Dr. Manuskiatti added that no other adverse effects were documented during the study.

“ Normally when you use laser to treat skin type I or II, you don’t have … PIH or darkening of the skin,” Dr. Manuskiatti told this news organization, “but when you have skin type III and above, you run into a really high incidence of postinflammatory hyperpigmentation — and treating that with fractional beam can lead to a reduced incidence of darkening of the skin afterward.”
 

A Lower-Cost Option

This study showed that the 532-nm picosecond laser with fractional beam MLA is a useful option for patients with darker skin types, Kelly Stankiewicz, MD, a dermatologist who practices in Park City, Utah, and moderated the session where these results were presented, told this news organization.

“The most challenging thing about treating lentigines in darker skin types is preventing potential side effects, mainly dyspigmentation,” she said after the meeting. “These side effects are, for the most part, temporary, but they can take 6-18 months to resolve, so it’s important to prevent them in the first place.”

She noted that the 532-nm and 1064-nm wavelengths are the most commonly available for picosecond lasers and that they’re easier to produce and less expensive. “There are picosecond lasers with middle wavelengths in the red light to near-infrared range (650-785 nm) that are better for darker skin types because they are more gentle yet still effective at targeting pigment, but these lasers are more expensive and less widely available,” Dr. Stankiewicz said. 

“The microlens array, used in this study with the 532-nm wavelength, is an inexpensive piece that fits at the end of the laser,” she added. “So, to have an option that turns a 532-nm laser into a safer device for the treatment of lentigines in darker skin types is very helpful.”

Dr. Manuskiatti and Dr. Stankiewicz had no relevant disclosures to report.
 

A version of this article first appeared on Medscape.com.

BALTIMORE — Patients who have complications after dermatologic cosmetic procedures are prone to high rates of a host of mental health issues, ranging from anxiety disorder and depression to body dysmorphic disorder (BDD) and posttraumatic stress disorder (PTSD), according to a survey-based study of patients with dermatology-related complications. 

The study used an anonymous 40-question survey circulated to a Facebook cosmetic complication support group. Seventy-one of 100 individuals completed the questionnaire, reporting significantly higher rates of mental health issues after their complications than before. Results were presented at the annual conference of the American Society for Laser Medicine and Surgery (ASLMS). Almost all the survey respondents (99%) were female, with 61% aged 25-44 years and 34% aged 45-64 years.

Murray_Taryn_Ohio_web.jpg

“Cosmetic procedures have increased over the past decade, with procedures being increasingly performed by an evolving variety of providers,” the study’s lead author, Taryn Murray, MD, a dermatologist at Cleveland Clinic, Cleveland, Ohio, told this news organization. “Appropriate patient assessment and counseling and proper procedure technique are important for obtaining safe and effective results. Complications may not only impact patients physically but can also be harmful to their mental health.”
 

Rise in Mental Health Issues

The study found that before respondents had the treatment that led to their complications, 16% reported a history of generalized anxiety disorder, 15% a history of depression, and 1% a history of either BDD or PTSD. Following the complication, 50% reported a positive depression screening, 63% a positive BDD Questionnaire – Dermatology Version, and 63% a positive Primary Care PTSD screen, Dr. Murray said. “Almost half of respondents (46%) reported thinking about their complication for more than 3 hours a day,” she said in presenting the results. 

Dr. Murray said the idea for the study grew out of her experience as a fellow working with Paul Friedman, MD, at the Dermatology and Laser Surgery Center at University of Texas Health in Houston.

“We were seeing a lot of complications,” Dr. Murray said in an interview. “Some of these were local. Some of these patients were flying in from out-of-state looking for help with the complication, and we could see what a mental and emotional burden this put on these patients. They were routinely in the office in tears saying it was interfering with their daily life, it was interfering with their job, saying they were going to lose their job, all because they were so distressed over what was happening to them.”

Yet, the research into psychological distress in patients with dermatologic complications is minimal, Dr. Murray added. “We think that body dysmorphic disorder is prevalent for patients seeking dermatology or plastic surgery services, but I don’t think either of the specialties do a great job in screening people for that when they come for treatment, so I think a lot of it goes undiagnosed. There’s been a trend looking at more at complications lately, but there’s been a gap in the literature.”

The treatments the patients in the survey had were microneedling with radiofrequency (29%), laser (24%), ultrasound for skin tightening (11%), radiofrequency for skin tightening (11%), microneedling (4%), chemical peel (3%), body contouring/sculpting (1%), and “other” (17%).

The study found that the largest share of procedures, 47%, were done by an esthetician/laser technician, followed by a nondermatologist physician (17%), a board-certified dermatologist (14%), an advanced practice provider (12%), and “other” (10%).

Self-reported complications included scarring (38%), hyperpigmentation (26%), erythema (24%), burn (23%), blisters (11%), and hypopigmentation (3%); 71% characterized their complications as “other,” and one respondent reported multiple complications.

“Respondents said they were satisfied with the previous cosmetic care they received,” Dr. Murray said during her presentation at the meeting. “And there was a consensus among the respondents that they did not feel adequately counseled on the risks of the procedure and that it did not meet their expectations and anticipated outcome.”
 

Take-Home Lesson

The lesson here is that practitioners who perform cosmetic procedures should be well-versed in the task and potential complications, Dr. Murray said in the interview. “If you’re going to be doing a procedure, make sure you know the proper techniques, the proper endpoints, and how to treat if you’re to have a complication,” she said. “If you don’t know how to treat a complication from the device, then you should think twice about using it.”

She also suggested screening patients for potentially undiagnosed mental health disorders. “It can play a role in the initial consultation and potentially any after-care they might need if there is a complication,” she said. “We may not have the adequate tools at this time to know how to best handle these patients and these scenarios, but hopefully my abstract will shed a little more light on it.”

She said she hopes her findings lead to more research in the future.

Asked to comment on the study, Jennifer Lin, MD, assistant professor of dermatology at Brigham and Women’s Hospital and Dana Farber Cancer Institute in Boston, Massachusetts, said one finding of the study stood out to her. “ I was very surprised from her dataset that patients think about it more than 3 hours a day,” she told this news organization. “That’s really significant. We talk about the side effects, but we don’t necessarily talk about the burden of how long the recovery will be or the psychological burden of potentially dealing with it.”

[embed:render:related:node:262554]

She noted that “there’s a bit of movement” toward developing guidelines for laser treatments, which would address the risk of complications. “That’s the goal: To have better guidelines to avoid these complications in the first place,” Dr. Lin said.

The study findings also point to a need for “premonitoring” individuals before procedures, she added. “We talked about patient selection and make sure someone doesn’t have body dysmorphic disorder, but we don’t formally screen for it,” she said. “We don’t our train our residents to screen for it. And I think doing more pre- and post-testing of how people are affected by laser treatment is going to become more important.”

Dr. Murray disclosed relationships with R2 Technologies. Dr. Lin had no relationships to disclose.

A version of this article appeared on Medscape.com.

BALTIMORE — Patients who have complications after dermatologic cosmetic procedures are prone to high rates of a host of mental health issues, ranging from anxiety disorder and depression to body dysmorphic disorder (BDD) and posttraumatic stress disorder (PTSD), according to a survey-based study of patients with dermatology-related complications. 

The study used an anonymous 40-question survey circulated to a Facebook cosmetic complication support group. Seventy-one of 100 individuals completed the questionnaire, reporting significantly higher rates of mental health issues after their complications than before. Results were presented at the annual conference of the American Society for Laser Medicine and Surgery (ASLMS). Almost all the survey respondents (99%) were female, with 61% aged 25-44 years and 34% aged 45-64 years.

Murray_Taryn_Ohio_web.jpg

“Cosmetic procedures have increased over the past decade, with procedures being increasingly performed by an evolving variety of providers,” the study’s lead author, Taryn Murray, MD, a dermatologist at Cleveland Clinic, Cleveland, Ohio, told this news organization. “Appropriate patient assessment and counseling and proper procedure technique are important for obtaining safe and effective results. Complications may not only impact patients physically but can also be harmful to their mental health.”
 

Rise in Mental Health Issues

The study found that before respondents had the treatment that led to their complications, 16% reported a history of generalized anxiety disorder, 15% a history of depression, and 1% a history of either BDD or PTSD. Following the complication, 50% reported a positive depression screening, 63% a positive BDD Questionnaire – Dermatology Version, and 63% a positive Primary Care PTSD screen, Dr. Murray said. “Almost half of respondents (46%) reported thinking about their complication for more than 3 hours a day,” she said in presenting the results. 

Dr. Murray said the idea for the study grew out of her experience as a fellow working with Paul Friedman, MD, at the Dermatology and Laser Surgery Center at University of Texas Health in Houston.

“We were seeing a lot of complications,” Dr. Murray said in an interview. “Some of these were local. Some of these patients were flying in from out-of-state looking for help with the complication, and we could see what a mental and emotional burden this put on these patients. They were routinely in the office in tears saying it was interfering with their daily life, it was interfering with their job, saying they were going to lose their job, all because they were so distressed over what was happening to them.”

Yet, the research into psychological distress in patients with dermatologic complications is minimal, Dr. Murray added. “We think that body dysmorphic disorder is prevalent for patients seeking dermatology or plastic surgery services, but I don’t think either of the specialties do a great job in screening people for that when they come for treatment, so I think a lot of it goes undiagnosed. There’s been a trend looking at more at complications lately, but there’s been a gap in the literature.”

The treatments the patients in the survey had were microneedling with radiofrequency (29%), laser (24%), ultrasound for skin tightening (11%), radiofrequency for skin tightening (11%), microneedling (4%), chemical peel (3%), body contouring/sculpting (1%), and “other” (17%).

The study found that the largest share of procedures, 47%, were done by an esthetician/laser technician, followed by a nondermatologist physician (17%), a board-certified dermatologist (14%), an advanced practice provider (12%), and “other” (10%).

Self-reported complications included scarring (38%), hyperpigmentation (26%), erythema (24%), burn (23%), blisters (11%), and hypopigmentation (3%); 71% characterized their complications as “other,” and one respondent reported multiple complications.

“Respondents said they were satisfied with the previous cosmetic care they received,” Dr. Murray said during her presentation at the meeting. “And there was a consensus among the respondents that they did not feel adequately counseled on the risks of the procedure and that it did not meet their expectations and anticipated outcome.”
 

Take-Home Lesson

The lesson here is that practitioners who perform cosmetic procedures should be well-versed in the task and potential complications, Dr. Murray said in the interview. “If you’re going to be doing a procedure, make sure you know the proper techniques, the proper endpoints, and how to treat if you’re to have a complication,” she said. “If you don’t know how to treat a complication from the device, then you should think twice about using it.”

She also suggested screening patients for potentially undiagnosed mental health disorders. “It can play a role in the initial consultation and potentially any after-care they might need if there is a complication,” she said. “We may not have the adequate tools at this time to know how to best handle these patients and these scenarios, but hopefully my abstract will shed a little more light on it.”

She said she hopes her findings lead to more research in the future.

Asked to comment on the study, Jennifer Lin, MD, assistant professor of dermatology at Brigham and Women’s Hospital and Dana Farber Cancer Institute in Boston, Massachusetts, said one finding of the study stood out to her. “ I was very surprised from her dataset that patients think about it more than 3 hours a day,” she told this news organization. “That’s really significant. We talk about the side effects, but we don’t necessarily talk about the burden of how long the recovery will be or the psychological burden of potentially dealing with it.”

[embed:render:related:node:262554]

She noted that “there’s a bit of movement” toward developing guidelines for laser treatments, which would address the risk of complications. “That’s the goal: To have better guidelines to avoid these complications in the first place,” Dr. Lin said.

The study findings also point to a need for “premonitoring” individuals before procedures, she added. “We talked about patient selection and make sure someone doesn’t have body dysmorphic disorder, but we don’t formally screen for it,” she said. “We don’t our train our residents to screen for it. And I think doing more pre- and post-testing of how people are affected by laser treatment is going to become more important.”

Dr. Murray disclosed relationships with R2 Technologies. Dr. Lin had no relationships to disclose.

A version of this article appeared on Medscape.com.

BALTIMORE — Patients who have complications after dermatologic cosmetic procedures are prone to high rates of a host of mental health issues, ranging from anxiety disorder and depression to body dysmorphic disorder (BDD) and posttraumatic stress disorder (PTSD), according to a survey-based study of patients with dermatology-related complications. 

The study used an anonymous 40-question survey circulated to a Facebook cosmetic complication support group. Seventy-one of 100 individuals completed the questionnaire, reporting significantly higher rates of mental health issues after their complications than before. Results were presented at the annual conference of the American Society for Laser Medicine and Surgery (ASLMS). Almost all the survey respondents (99%) were female, with 61% aged 25-44 years and 34% aged 45-64 years.

Murray_Taryn_Ohio_web.jpg

“Cosmetic procedures have increased over the past decade, with procedures being increasingly performed by an evolving variety of providers,” the study’s lead author, Taryn Murray, MD, a dermatologist at Cleveland Clinic, Cleveland, Ohio, told this news organization. “Appropriate patient assessment and counseling and proper procedure technique are important for obtaining safe and effective results. Complications may not only impact patients physically but can also be harmful to their mental health.”
 

Rise in Mental Health Issues

The study found that before respondents had the treatment that led to their complications, 16% reported a history of generalized anxiety disorder, 15% a history of depression, and 1% a history of either BDD or PTSD. Following the complication, 50% reported a positive depression screening, 63% a positive BDD Questionnaire – Dermatology Version, and 63% a positive Primary Care PTSD screen, Dr. Murray said. “Almost half of respondents (46%) reported thinking about their complication for more than 3 hours a day,” she said in presenting the results. 

Dr. Murray said the idea for the study grew out of her experience as a fellow working with Paul Friedman, MD, at the Dermatology and Laser Surgery Center at University of Texas Health in Houston.

“We were seeing a lot of complications,” Dr. Murray said in an interview. “Some of these were local. Some of these patients were flying in from out-of-state looking for help with the complication, and we could see what a mental and emotional burden this put on these patients. They were routinely in the office in tears saying it was interfering with their daily life, it was interfering with their job, saying they were going to lose their job, all because they were so distressed over what was happening to them.”

Yet, the research into psychological distress in patients with dermatologic complications is minimal, Dr. Murray added. “We think that body dysmorphic disorder is prevalent for patients seeking dermatology or plastic surgery services, but I don’t think either of the specialties do a great job in screening people for that when they come for treatment, so I think a lot of it goes undiagnosed. There’s been a trend looking at more at complications lately, but there’s been a gap in the literature.”

The treatments the patients in the survey had were microneedling with radiofrequency (29%), laser (24%), ultrasound for skin tightening (11%), radiofrequency for skin tightening (11%), microneedling (4%), chemical peel (3%), body contouring/sculpting (1%), and “other” (17%).

The study found that the largest share of procedures, 47%, were done by an esthetician/laser technician, followed by a nondermatologist physician (17%), a board-certified dermatologist (14%), an advanced practice provider (12%), and “other” (10%).

Self-reported complications included scarring (38%), hyperpigmentation (26%), erythema (24%), burn (23%), blisters (11%), and hypopigmentation (3%); 71% characterized their complications as “other,” and one respondent reported multiple complications.

“Respondents said they were satisfied with the previous cosmetic care they received,” Dr. Murray said during her presentation at the meeting. “And there was a consensus among the respondents that they did not feel adequately counseled on the risks of the procedure and that it did not meet their expectations and anticipated outcome.”
 

Take-Home Lesson

The lesson here is that practitioners who perform cosmetic procedures should be well-versed in the task and potential complications, Dr. Murray said in the interview. “If you’re going to be doing a procedure, make sure you know the proper techniques, the proper endpoints, and how to treat if you’re to have a complication,” she said. “If you don’t know how to treat a complication from the device, then you should think twice about using it.”

She also suggested screening patients for potentially undiagnosed mental health disorders. “It can play a role in the initial consultation and potentially any after-care they might need if there is a complication,” she said. “We may not have the adequate tools at this time to know how to best handle these patients and these scenarios, but hopefully my abstract will shed a little more light on it.”

She said she hopes her findings lead to more research in the future.

Asked to comment on the study, Jennifer Lin, MD, assistant professor of dermatology at Brigham and Women’s Hospital and Dana Farber Cancer Institute in Boston, Massachusetts, said one finding of the study stood out to her. “ I was very surprised from her dataset that patients think about it more than 3 hours a day,” she told this news organization. “That’s really significant. We talk about the side effects, but we don’t necessarily talk about the burden of how long the recovery will be or the psychological burden of potentially dealing with it.”

[embed:render:related:node:262554]

She noted that “there’s a bit of movement” toward developing guidelines for laser treatments, which would address the risk of complications. “That’s the goal: To have better guidelines to avoid these complications in the first place,” Dr. Lin said.

The study findings also point to a need for “premonitoring” individuals before procedures, she added. “We talked about patient selection and make sure someone doesn’t have body dysmorphic disorder, but we don’t formally screen for it,” she said. “We don’t our train our residents to screen for it. And I think doing more pre- and post-testing of how people are affected by laser treatment is going to become more important.”

Dr. Murray disclosed relationships with R2 Technologies. Dr. Lin had no relationships to disclose.

A version of this article appeared on Medscape.com.

ATLANTA — Patients with acute coronary syndrome (ACS) who had a myocardial infarction or unstable angina and underwent percutaneous coronary intervention (PCI) had a 76% lower rate of hospital readmission after 6 months if they participated in a remote monitoring protocol compared with similar patients who had standard post-discharge care, results of a new trial suggest.

The TELE-ACS trial showed that at 6 months, telemedicine patients also had statistically significantly lower rates of post-discharge emergency department visits, unplanned coronary revascularizations, and cardiovascular symptoms, such as chest pain, shortness of breath and dizziness. However, the rates of major adverse cardiovascular events (MACE) were similar between the two groups. The protocol included consultation with a cardiologist who reviewed home-monitoring data.

“The team was able to aid in preventing unnecessary presentations and advised the patients to seek emergency care whenever was necessary,” Nasser Alshahrani, MSc, a clinical research fellow at Imperial College London, said while presenting the results at the American College of Cardiology meeting. “The TELE-ACS protocol provided a significant reduction in readmission rates post-ACS and other adverse events.” 

The study findings were published online simultaneously in the Journal of the American College of Cardiology.
 

Telemedicine Protocol

The trial, conducted from January 2022 to April 2023, randomly assigned 337 patients to telemedicine or standard care when they were discharged after PCI and had at least one cardiovascular risk factor. The telemedicine protocol consisted of 12-lead electrocardiogram belt, an automated blood-pressure monitor, and a pulse oximeter. 

Patients in the telemedicine arm initiated the remote monitoring protocol if they thought they had cardiac symptoms. The majority (86%) were men with what the study described as “a high preponderance of cardiovascular risk factors.” Average age was 58.1 years. 

If a telemedicine patient initiated the protocol, a cardiologist remotely assessed the patient’s symptoms and channeled the patient to the appropriate care pathway, whether reassuring the patient or sending them to a primary care physician or emergency department, or to call emergency services. Patients who didn’t get a call back from the cardiologist within 15 minutes were told to seek care in the standard clinical pathway.

Telemedicine patients were given the telemonitoring package and training in how to use the devices before they were discharged. They also received three follow-up quality control calls in the first two months to ensure they were using the equipment correctly. They kept the telemonitoring equipment for 8 months, but were followed out to 9 months. Six telemedicine patients dropped out while one standard care patient withdrew from the study.

Results showed that at 6 months, telemedicine patients had statistically significantly lower rates of post-discharge emergency department visits (25% vs 37%, P < .001), unplanned coronary revascularizations (3% vs 9%, P < .01) and cardiovascular symptoms, such as chest pain, shortness of breath and dizziness (a 13% to 18% difference for each symptom, P < .01).

MACE rates were similar between the two groups.

At 9 months, 3 months after the protocol ended, 20 telemedicine patients and 50 standard-care patients were readmitted to the hospital, while 52 and 73, respectively, went to the emergency department.

The telemedicine patients also had shorter hospital stays: an average of 0.5 and 1.2 days at 6 and 9 months, respectively, vs 1.5 and 1.8 days in the standard treatment arm (P < .001 for both).

Mr. Alshahrani noted several limitations with the study, namely that 86% of participants were men, and that the intervention was only offered to people who had smartphones. “The high level of support for the telemedicine group, with prompt cardiology responses, may be challenging to replicate outside a trial setting, requiring significant investment and training,” he added.
 

Human Element Key

In an interview from London after the presentation, lead author Ramzi Khamis, MB ChB, PhD, said, “This was quite a basic study. Really what we did was we integrated a clinical decision-making algorithm that we perfected with some quite novel but basic technology.” Future research should strive to add a home troponin test to the protocol and an artificial intelligence component, he said.

However, Dr. Khamis noted that human interaction was key to the success of the TELE-ACS trial. “The human factor is very important here and I think it would be really interesting to have a head-to-head comparison of human interaction with remote monitoring vs an AI-driven interaction,” he said. “I have my doubts that AI would be able to beat the human factor here.”

Lawrence Phillips, MD, medical director of outpatient cardiology at NYU Langone Heart, told this news organization that the study was appropriately powered to evaluate the telemedicine protocol, and that it could serve as a template for other studies of remote monitoring in cardiology. 

“I think that this study is forming the foundation of evolving telemedicine data,” he said. “It shows really interesting results, and I’m sure it’s going to be reproduced in different ways going forward.”

While other studies have shown the utility of telemedicine to decrease unnecessary hospitalizations, this study went one step further, Dr. Phillips said. “What was unique about this study was the package that they put together,” he added. “It was a combination of telehealth and being able to speak with someone when you have concerns with objective data of an electrocardiogram, blood-pressure cuff, and oxygen level assessment, which is an interesting approach having that ejective data with [a] subjective element.”

The trial received funding from the British Heart Foundation; King Khalid University, Abha, Saudi Arabia via The Saudi Arabian Cultural Bureau; Sansour Fund, Imperial Healthcare Charity; and Safwan Sobhan Fund at Imperial College London. Mr. Alshahrani and Dr. Khamis have no relevant relationships to disclose. Dr. Phillips has no relevant disclosures.

A version of this article first appeared on Medscape.com.

ATLANTA — Patients with acute coronary syndrome (ACS) who had a myocardial infarction or unstable angina and underwent percutaneous coronary intervention (PCI) had a 76% lower rate of hospital readmission after 6 months if they participated in a remote monitoring protocol compared with similar patients who had standard post-discharge care, results of a new trial suggest.

The TELE-ACS trial showed that at 6 months, telemedicine patients also had statistically significantly lower rates of post-discharge emergency department visits, unplanned coronary revascularizations, and cardiovascular symptoms, such as chest pain, shortness of breath and dizziness. However, the rates of major adverse cardiovascular events (MACE) were similar between the two groups. The protocol included consultation with a cardiologist who reviewed home-monitoring data.

“The team was able to aid in preventing unnecessary presentations and advised the patients to seek emergency care whenever was necessary,” Nasser Alshahrani, MSc, a clinical research fellow at Imperial College London, said while presenting the results at the American College of Cardiology meeting. “The TELE-ACS protocol provided a significant reduction in readmission rates post-ACS and other adverse events.” 

The study findings were published online simultaneously in the Journal of the American College of Cardiology.
 

Telemedicine Protocol

The trial, conducted from January 2022 to April 2023, randomly assigned 337 patients to telemedicine or standard care when they were discharged after PCI and had at least one cardiovascular risk factor. The telemedicine protocol consisted of 12-lead electrocardiogram belt, an automated blood-pressure monitor, and a pulse oximeter. 

Patients in the telemedicine arm initiated the remote monitoring protocol if they thought they had cardiac symptoms. The majority (86%) were men with what the study described as “a high preponderance of cardiovascular risk factors.” Average age was 58.1 years. 

If a telemedicine patient initiated the protocol, a cardiologist remotely assessed the patient’s symptoms and channeled the patient to the appropriate care pathway, whether reassuring the patient or sending them to a primary care physician or emergency department, or to call emergency services. Patients who didn’t get a call back from the cardiologist within 15 minutes were told to seek care in the standard clinical pathway.

Telemedicine patients were given the telemonitoring package and training in how to use the devices before they were discharged. They also received three follow-up quality control calls in the first two months to ensure they were using the equipment correctly. They kept the telemonitoring equipment for 8 months, but were followed out to 9 months. Six telemedicine patients dropped out while one standard care patient withdrew from the study.

Results showed that at 6 months, telemedicine patients had statistically significantly lower rates of post-discharge emergency department visits (25% vs 37%, P < .001), unplanned coronary revascularizations (3% vs 9%, P < .01) and cardiovascular symptoms, such as chest pain, shortness of breath and dizziness (a 13% to 18% difference for each symptom, P < .01).

MACE rates were similar between the two groups.

At 9 months, 3 months after the protocol ended, 20 telemedicine patients and 50 standard-care patients were readmitted to the hospital, while 52 and 73, respectively, went to the emergency department.

The telemedicine patients also had shorter hospital stays: an average of 0.5 and 1.2 days at 6 and 9 months, respectively, vs 1.5 and 1.8 days in the standard treatment arm (P < .001 for both).

Mr. Alshahrani noted several limitations with the study, namely that 86% of participants were men, and that the intervention was only offered to people who had smartphones. “The high level of support for the telemedicine group, with prompt cardiology responses, may be challenging to replicate outside a trial setting, requiring significant investment and training,” he added.
 

Human Element Key

In an interview from London after the presentation, lead author Ramzi Khamis, MB ChB, PhD, said, “This was quite a basic study. Really what we did was we integrated a clinical decision-making algorithm that we perfected with some quite novel but basic technology.” Future research should strive to add a home troponin test to the protocol and an artificial intelligence component, he said.

However, Dr. Khamis noted that human interaction was key to the success of the TELE-ACS trial. “The human factor is very important here and I think it would be really interesting to have a head-to-head comparison of human interaction with remote monitoring vs an AI-driven interaction,” he said. “I have my doubts that AI would be able to beat the human factor here.”

Lawrence Phillips, MD, medical director of outpatient cardiology at NYU Langone Heart, told this news organization that the study was appropriately powered to evaluate the telemedicine protocol, and that it could serve as a template for other studies of remote monitoring in cardiology. 

“I think that this study is forming the foundation of evolving telemedicine data,” he said. “It shows really interesting results, and I’m sure it’s going to be reproduced in different ways going forward.”

While other studies have shown the utility of telemedicine to decrease unnecessary hospitalizations, this study went one step further, Dr. Phillips said. “What was unique about this study was the package that they put together,” he added. “It was a combination of telehealth and being able to speak with someone when you have concerns with objective data of an electrocardiogram, blood-pressure cuff, and oxygen level assessment, which is an interesting approach having that ejective data with [a] subjective element.”

The trial received funding from the British Heart Foundation; King Khalid University, Abha, Saudi Arabia via The Saudi Arabian Cultural Bureau; Sansour Fund, Imperial Healthcare Charity; and Safwan Sobhan Fund at Imperial College London. Mr. Alshahrani and Dr. Khamis have no relevant relationships to disclose. Dr. Phillips has no relevant disclosures.

A version of this article first appeared on Medscape.com.

ATLANTA — Patients with acute coronary syndrome (ACS) who had a myocardial infarction or unstable angina and underwent percutaneous coronary intervention (PCI) had a 76% lower rate of hospital readmission after 6 months if they participated in a remote monitoring protocol compared with similar patients who had standard post-discharge care, results of a new trial suggest.

The TELE-ACS trial showed that at 6 months, telemedicine patients also had statistically significantly lower rates of post-discharge emergency department visits, unplanned coronary revascularizations, and cardiovascular symptoms, such as chest pain, shortness of breath and dizziness. However, the rates of major adverse cardiovascular events (MACE) were similar between the two groups. The protocol included consultation with a cardiologist who reviewed home-monitoring data.

“The team was able to aid in preventing unnecessary presentations and advised the patients to seek emergency care whenever was necessary,” Nasser Alshahrani, MSc, a clinical research fellow at Imperial College London, said while presenting the results at the American College of Cardiology meeting. “The TELE-ACS protocol provided a significant reduction in readmission rates post-ACS and other adverse events.” 

The study findings were published online simultaneously in the Journal of the American College of Cardiology.
 

Telemedicine Protocol

The trial, conducted from January 2022 to April 2023, randomly assigned 337 patients to telemedicine or standard care when they were discharged after PCI and had at least one cardiovascular risk factor. The telemedicine protocol consisted of 12-lead electrocardiogram belt, an automated blood-pressure monitor, and a pulse oximeter. 

Patients in the telemedicine arm initiated the remote monitoring protocol if they thought they had cardiac symptoms. The majority (86%) were men with what the study described as “a high preponderance of cardiovascular risk factors.” Average age was 58.1 years. 

If a telemedicine patient initiated the protocol, a cardiologist remotely assessed the patient’s symptoms and channeled the patient to the appropriate care pathway, whether reassuring the patient or sending them to a primary care physician or emergency department, or to call emergency services. Patients who didn’t get a call back from the cardiologist within 15 minutes were told to seek care in the standard clinical pathway.

Telemedicine patients were given the telemonitoring package and training in how to use the devices before they were discharged. They also received three follow-up quality control calls in the first two months to ensure they were using the equipment correctly. They kept the telemonitoring equipment for 8 months, but were followed out to 9 months. Six telemedicine patients dropped out while one standard care patient withdrew from the study.

Results showed that at 6 months, telemedicine patients had statistically significantly lower rates of post-discharge emergency department visits (25% vs 37%, P < .001), unplanned coronary revascularizations (3% vs 9%, P < .01) and cardiovascular symptoms, such as chest pain, shortness of breath and dizziness (a 13% to 18% difference for each symptom, P < .01).

MACE rates were similar between the two groups.

At 9 months, 3 months after the protocol ended, 20 telemedicine patients and 50 standard-care patients were readmitted to the hospital, while 52 and 73, respectively, went to the emergency department.

The telemedicine patients also had shorter hospital stays: an average of 0.5 and 1.2 days at 6 and 9 months, respectively, vs 1.5 and 1.8 days in the standard treatment arm (P < .001 for both).

Mr. Alshahrani noted several limitations with the study, namely that 86% of participants were men, and that the intervention was only offered to people who had smartphones. “The high level of support for the telemedicine group, with prompt cardiology responses, may be challenging to replicate outside a trial setting, requiring significant investment and training,” he added.
 

Human Element Key

In an interview from London after the presentation, lead author Ramzi Khamis, MB ChB, PhD, said, “This was quite a basic study. Really what we did was we integrated a clinical decision-making algorithm that we perfected with some quite novel but basic technology.” Future research should strive to add a home troponin test to the protocol and an artificial intelligence component, he said.

However, Dr. Khamis noted that human interaction was key to the success of the TELE-ACS trial. “The human factor is very important here and I think it would be really interesting to have a head-to-head comparison of human interaction with remote monitoring vs an AI-driven interaction,” he said. “I have my doubts that AI would be able to beat the human factor here.”

Lawrence Phillips, MD, medical director of outpatient cardiology at NYU Langone Heart, told this news organization that the study was appropriately powered to evaluate the telemedicine protocol, and that it could serve as a template for other studies of remote monitoring in cardiology. 

“I think that this study is forming the foundation of evolving telemedicine data,” he said. “It shows really interesting results, and I’m sure it’s going to be reproduced in different ways going forward.”

While other studies have shown the utility of telemedicine to decrease unnecessary hospitalizations, this study went one step further, Dr. Phillips said. “What was unique about this study was the package that they put together,” he added. “It was a combination of telehealth and being able to speak with someone when you have concerns with objective data of an electrocardiogram, blood-pressure cuff, and oxygen level assessment, which is an interesting approach having that ejective data with [a] subjective element.”

The trial received funding from the British Heart Foundation; King Khalid University, Abha, Saudi Arabia via The Saudi Arabian Cultural Bureau; Sansour Fund, Imperial Healthcare Charity; and Safwan Sobhan Fund at Imperial College London. Mr. Alshahrani and Dr. Khamis have no relevant relationships to disclose. Dr. Phillips has no relevant disclosures.

A version of this article first appeared on Medscape.com.

You can’t spell “ophthalmologist” without artificial intelligence (AI) — a fact that might have many eye specialists looking warily over their shoulders. But should they be concerned, or is it time to embrace the new technology?

Ophthalmologists, like most other medical specialists, might be looking warily over their shoulders as AI continues to evolve. But should they be concerned, or is it time to embrace the new technology?

Two recent studies have demonstrated the ability of AI to match ophthalmologists’ answers to patients’ questions about eye disease, and the technology is poised to assist ophthalmologists in managing patient workflow and overcome shortages in the ophthalmic workforce, attendees at the American Glaucoma Society meeting presented on March 2, 2024, in Huntington Beach, California, were told.

A study at the Icahn School of Medicine at Mount Sinai in New York City found chatbots matched the proficiency of fellowship-trained ophthalmologists in diagnostic accuracy and completeness in handling questions about eye disease and real patient cases. Another study found a similar result in handling 200 eye care questions from an online chat forum, Robert Chang, MD, co-author of the second study and a glaucoma specialist and associate professor of ophthalmology at Stanford University in Stanford, California, reported.

“Using prompt engineering of ChatGPT, replies to patient online forum questions are becoming so realistic that specialist physicians are having difficulty telling the difference between human- and machine-generated responses,” Dr. Chang said.

The study used questions patients submitted to an online medical forum that received responses from ophthalmologists, then presented those responses plus answers generated by ChatGPT to a panel of eight ophthalmologists and asked them to distinguish between the two. “The accuracy of judging whether you could tell if it was written by AI or a human was about 61%,” Dr. Chang reported. “So most of the time you could not tell the difference.”

The study reported that of 800 evaluations of chatbot-written answers, ophthalmologists rated 21% of them as human-written, while they marked 64.6% of human-written answers as AI-written. The study also found that the likelihood of chatbot answers containing incorrect or inappropriate material was comparable with human answers: Less than 1% for both.

Dr. Chang also referenced a similar, more recent study from the Icahn School of Medicine in which 15 clinicians reviewed answers to patient questions by fellowship-trained glaucoma and retina specialists and those generated by ChatGPT-4, the chatbot model released by OpenAI in the spring of 2023. The study used a statistical tool to evaluate the combined question-case mean rank for accuracy, which was 506.2 for ChatGPT and 403.4 for glaucoma specialists based on 831 question cases. The mean rank for completeness was 528.3 and 398.7, respectively, based on 828 question cases (P < .001).

“The specialists themselves didn’t rate their answers as good as they rated the chatbot answers,” Dr. Chang said. “So it’s really showing that what we can come up with generative AI so human-like that it’s difficult for us to tell the difference on accuracy and completeness.”
 

‘Getting Close’

However, he noted that chatbots still have some kinks to work out with factual errors, difficulty referencing reliable sources, and hallucinations — fabricated material that may not be accurate. “We’re not quite there yet, but it’s getting close,” Dr. Chang added.

Dr. Chang noted that his clinic at Stanford is testing an AI platform to perform virtual scribing of patient encounters in real time. “That can save a lot of time on documentation,” he said. “I think this is a direction moving forward to increase our productivity because as we know, we all have workforce problems whether it’s the doctors or having enough technicians.”

Chatbots also are being tested for scheduling and generating letters. “Because of the unique needs of each ophthalmologist, AI agents that augment the existing workforce on specific administrative tasks will be the most likely early use case rather than autonomous disease screening or clinical decision support tools, which will take longer to validate prospectively in specific cohorts,” he said.

“Any AI today still has a long way to go before it can ingest and verify all the data for independent decision-making and be validated for fairness and generalizability,” Dr. Chang added. “It is much easier to have ‘low-level thinking’, repetitive tasks be taken care of by algorithms first.”

Dr. Chang “made a convincing case for embracing currently feasible applications of AI, highlighting the potential benefits of leveraging LLMs such as ChatGPT to enhance clinical productivity,” said Thasarat Vajaranant, MD, MHA, director of the glaucoma service and of data sourcing and strategy for the AI Ophthalmology Center at Illinois Eye and Ear Infirmary and the University of Illinois Chicago.

“With the growing demands of an aging population and workforce shortages in ophthalmology, AI-driven solutions offer promise in various areas, including telemedicine triage, organizing clinical notes, assisting in assessments and treatment planning, and virtual scribing,” Dr. Vajaranant said. “Rather than fearing this technology, we should approach its integration with caution.”

Dr. Chang disclosed relationships with Alcon, Genentech/Roche, Itnalight, Verana Health, Sight Sciences, Ocular Therapeutix, Glaukos, Carl Zeiss Meditec, and Apple. Dr. Vajaranant had no relevant disclosures.

A version of this article first appeared on Medscape.com.

You can’t spell “ophthalmologist” without artificial intelligence (AI) — a fact that might have many eye specialists looking warily over their shoulders. But should they be concerned, or is it time to embrace the new technology?

Ophthalmologists, like most other medical specialists, might be looking warily over their shoulders as AI continues to evolve. But should they be concerned, or is it time to embrace the new technology?

Two recent studies have demonstrated the ability of AI to match ophthalmologists’ answers to patients’ questions about eye disease, and the technology is poised to assist ophthalmologists in managing patient workflow and overcome shortages in the ophthalmic workforce, attendees at the American Glaucoma Society meeting presented on March 2, 2024, in Huntington Beach, California, were told.

A study at the Icahn School of Medicine at Mount Sinai in New York City found chatbots matched the proficiency of fellowship-trained ophthalmologists in diagnostic accuracy and completeness in handling questions about eye disease and real patient cases. Another study found a similar result in handling 200 eye care questions from an online chat forum, Robert Chang, MD, co-author of the second study and a glaucoma specialist and associate professor of ophthalmology at Stanford University in Stanford, California, reported.

“Using prompt engineering of ChatGPT, replies to patient online forum questions are becoming so realistic that specialist physicians are having difficulty telling the difference between human- and machine-generated responses,” Dr. Chang said.

The study used questions patients submitted to an online medical forum that received responses from ophthalmologists, then presented those responses plus answers generated by ChatGPT to a panel of eight ophthalmologists and asked them to distinguish between the two. “The accuracy of judging whether you could tell if it was written by AI or a human was about 61%,” Dr. Chang reported. “So most of the time you could not tell the difference.”

The study reported that of 800 evaluations of chatbot-written answers, ophthalmologists rated 21% of them as human-written, while they marked 64.6% of human-written answers as AI-written. The study also found that the likelihood of chatbot answers containing incorrect or inappropriate material was comparable with human answers: Less than 1% for both.

Dr. Chang also referenced a similar, more recent study from the Icahn School of Medicine in which 15 clinicians reviewed answers to patient questions by fellowship-trained glaucoma and retina specialists and those generated by ChatGPT-4, the chatbot model released by OpenAI in the spring of 2023. The study used a statistical tool to evaluate the combined question-case mean rank for accuracy, which was 506.2 for ChatGPT and 403.4 for glaucoma specialists based on 831 question cases. The mean rank for completeness was 528.3 and 398.7, respectively, based on 828 question cases (P < .001).

“The specialists themselves didn’t rate their answers as good as they rated the chatbot answers,” Dr. Chang said. “So it’s really showing that what we can come up with generative AI so human-like that it’s difficult for us to tell the difference on accuracy and completeness.”
 

‘Getting Close’

However, he noted that chatbots still have some kinks to work out with factual errors, difficulty referencing reliable sources, and hallucinations — fabricated material that may not be accurate. “We’re not quite there yet, but it’s getting close,” Dr. Chang added.

Dr. Chang noted that his clinic at Stanford is testing an AI platform to perform virtual scribing of patient encounters in real time. “That can save a lot of time on documentation,” he said. “I think this is a direction moving forward to increase our productivity because as we know, we all have workforce problems whether it’s the doctors or having enough technicians.”

Chatbots also are being tested for scheduling and generating letters. “Because of the unique needs of each ophthalmologist, AI agents that augment the existing workforce on specific administrative tasks will be the most likely early use case rather than autonomous disease screening or clinical decision support tools, which will take longer to validate prospectively in specific cohorts,” he said.

“Any AI today still has a long way to go before it can ingest and verify all the data for independent decision-making and be validated for fairness and generalizability,” Dr. Chang added. “It is much easier to have ‘low-level thinking’, repetitive tasks be taken care of by algorithms first.”

Dr. Chang “made a convincing case for embracing currently feasible applications of AI, highlighting the potential benefits of leveraging LLMs such as ChatGPT to enhance clinical productivity,” said Thasarat Vajaranant, MD, MHA, director of the glaucoma service and of data sourcing and strategy for the AI Ophthalmology Center at Illinois Eye and Ear Infirmary and the University of Illinois Chicago.

“With the growing demands of an aging population and workforce shortages in ophthalmology, AI-driven solutions offer promise in various areas, including telemedicine triage, organizing clinical notes, assisting in assessments and treatment planning, and virtual scribing,” Dr. Vajaranant said. “Rather than fearing this technology, we should approach its integration with caution.”

Dr. Chang disclosed relationships with Alcon, Genentech/Roche, Itnalight, Verana Health, Sight Sciences, Ocular Therapeutix, Glaukos, Carl Zeiss Meditec, and Apple. Dr. Vajaranant had no relevant disclosures.

A version of this article first appeared on Medscape.com.

You can’t spell “ophthalmologist” without artificial intelligence (AI) — a fact that might have many eye specialists looking warily over their shoulders. But should they be concerned, or is it time to embrace the new technology?

Ophthalmologists, like most other medical specialists, might be looking warily over their shoulders as AI continues to evolve. But should they be concerned, or is it time to embrace the new technology?

Two recent studies have demonstrated the ability of AI to match ophthalmologists’ answers to patients’ questions about eye disease, and the technology is poised to assist ophthalmologists in managing patient workflow and overcome shortages in the ophthalmic workforce, attendees at the American Glaucoma Society meeting presented on March 2, 2024, in Huntington Beach, California, were told.

A study at the Icahn School of Medicine at Mount Sinai in New York City found chatbots matched the proficiency of fellowship-trained ophthalmologists in diagnostic accuracy and completeness in handling questions about eye disease and real patient cases. Another study found a similar result in handling 200 eye care questions from an online chat forum, Robert Chang, MD, co-author of the second study and a glaucoma specialist and associate professor of ophthalmology at Stanford University in Stanford, California, reported.

“Using prompt engineering of ChatGPT, replies to patient online forum questions are becoming so realistic that specialist physicians are having difficulty telling the difference between human- and machine-generated responses,” Dr. Chang said.

The study used questions patients submitted to an online medical forum that received responses from ophthalmologists, then presented those responses plus answers generated by ChatGPT to a panel of eight ophthalmologists and asked them to distinguish between the two. “The accuracy of judging whether you could tell if it was written by AI or a human was about 61%,” Dr. Chang reported. “So most of the time you could not tell the difference.”

The study reported that of 800 evaluations of chatbot-written answers, ophthalmologists rated 21% of them as human-written, while they marked 64.6% of human-written answers as AI-written. The study also found that the likelihood of chatbot answers containing incorrect or inappropriate material was comparable with human answers: Less than 1% for both.

Dr. Chang also referenced a similar, more recent study from the Icahn School of Medicine in which 15 clinicians reviewed answers to patient questions by fellowship-trained glaucoma and retina specialists and those generated by ChatGPT-4, the chatbot model released by OpenAI in the spring of 2023. The study used a statistical tool to evaluate the combined question-case mean rank for accuracy, which was 506.2 for ChatGPT and 403.4 for glaucoma specialists based on 831 question cases. The mean rank for completeness was 528.3 and 398.7, respectively, based on 828 question cases (P < .001).

“The specialists themselves didn’t rate their answers as good as they rated the chatbot answers,” Dr. Chang said. “So it’s really showing that what we can come up with generative AI so human-like that it’s difficult for us to tell the difference on accuracy and completeness.”
 

‘Getting Close’

However, he noted that chatbots still have some kinks to work out with factual errors, difficulty referencing reliable sources, and hallucinations — fabricated material that may not be accurate. “We’re not quite there yet, but it’s getting close,” Dr. Chang added.

Dr. Chang noted that his clinic at Stanford is testing an AI platform to perform virtual scribing of patient encounters in real time. “That can save a lot of time on documentation,” he said. “I think this is a direction moving forward to increase our productivity because as we know, we all have workforce problems whether it’s the doctors or having enough technicians.”

Chatbots also are being tested for scheduling and generating letters. “Because of the unique needs of each ophthalmologist, AI agents that augment the existing workforce on specific administrative tasks will be the most likely early use case rather than autonomous disease screening or clinical decision support tools, which will take longer to validate prospectively in specific cohorts,” he said.

“Any AI today still has a long way to go before it can ingest and verify all the data for independent decision-making and be validated for fairness and generalizability,” Dr. Chang added. “It is much easier to have ‘low-level thinking’, repetitive tasks be taken care of by algorithms first.”

Dr. Chang “made a convincing case for embracing currently feasible applications of AI, highlighting the potential benefits of leveraging LLMs such as ChatGPT to enhance clinical productivity,” said Thasarat Vajaranant, MD, MHA, director of the glaucoma service and of data sourcing and strategy for the AI Ophthalmology Center at Illinois Eye and Ear Infirmary and the University of Illinois Chicago.

“With the growing demands of an aging population and workforce shortages in ophthalmology, AI-driven solutions offer promise in various areas, including telemedicine triage, organizing clinical notes, assisting in assessments and treatment planning, and virtual scribing,” Dr. Vajaranant said. “Rather than fearing this technology, we should approach its integration with caution.”

Dr. Chang disclosed relationships with Alcon, Genentech/Roche, Itnalight, Verana Health, Sight Sciences, Ocular Therapeutix, Glaukos, Carl Zeiss Meditec, and Apple. Dr. Vajaranant had no relevant disclosures.

A version of this article first appeared on Medscape.com.

The burdens that monthly or every-other-month injections in the eye impose on patients with retinal diseases are well-known to be barriers to care for many people with these conditions. Making treatment less onerous has driven research into new treatments since the US Food and Drug Administration (FDA) approved ranibizumab (Lucentis) in 2006 as the first anti–vascular endothelial growth factor (VEGF) for the treatment of age-related macular degeneration (AMD) and other retinal diseases.

Those new treatments include combination therapies, novel drug delivery systems, and a host of oral and topical medications to boost gains in visual acuity and extend the intervals between injections or avoid the injections altogether. Several of those investigational therapies are poised to hit meaningful milestones in 2024.
 

Regular Eye Injections: How We Got Here

Ranibizumab originally received approval as a monthly injection. Since then, protocols have evolved to space those injections out to every other month in some, but not all, patients.

New drugs have emerged that require less frequent injections. In 2022, the anti-VEGF and angiopoietin-2 inhibitor faricimab (Vabysmo) was approved for dosing up to every 4 months. Last year, the FDA approved a high-dose formulation of the anti-VEGF treatment aflibercept 8 mg (Eylea HD) to be given every 2-4 months, as well.

But even these treatments require patients going to the office at least three or four times a year for injections, Reginald Sanders, MD, president of the American Society of Retina Specialist, Chicago, and a retina specialist in Washington, DC, told this news organization. “Now with injections, you have the anxiety of getting the injections, you have the inconvenience of coming in on a regular basis to get the injections, and you have mild discomfort — but you don’t go blind,” Dr. Sanders said.

Studies have shown patients with AMD or diabetic macular edema are better off getting more frequent injections, but still drug developers are seeking the holy grail of fewer injections. “How do we make these treatments last longer?” Dr. Sanders said. “Durability has become the catchword in our field. Instead of lasting a month or 2, can it last 3 months? Can it last 6 months? Or even a year? Can you get one injection and be done with it?”

Or, no injection at all?

“We’re looking for incremental improvements and longer-acting drugs, trying to lengthen the time between injections for wet AMD patients,” said David Boyer, MD, a retina specialist in Los Angeles.
 

Two Drugs May Be Better Than One

One combination treatment, sozinibercept, targets VEGF-C and D. The therapy is in two phase 3 trials: One in combination with aflibercept 2 mg (Eylea), which targets VEGF-A and B along with placental growth factor, and the other in combination with ranibizumab, which targets VEGF-A only. Data from one of those trials are expected this year, Dr. Boyer said.

A phase 2 trial last year reported that patients on combination sozinibercept-ranibizumab had significantly better visual acuity improvement than patients on ranibizumab only. The phase 3 trials ShORe with ranibizumab and COAST with aflibercept are evaluating improvements in visual acuity and retinal anatomy.

Two other combination therapies are in phase 2 trials, both with aflibercept: UBX1325 or foselutoclax, a small-molecule inhibitor of B-cell lymphoma extra-large, and umedaptanib pegol, an anti-fibroblast growth factor-2 aptamer. In the foselutoclax-aflibercept trial, 40% of patients didn’t need a supplemental anti-VEGF injection through 48 weeks, and 64% went treatment-free for more than 24 weeks.

Phase 2 trials of intravitreal umedaptanib pegol-aflibercept combination therapy in nAMD last year showed no superiority in vision and anatomical improvements over aflibercept alone but did find the combination halted disease progression, with “striking improvement” in previously untreated patients.
 

Novel Drug Delivery Systems

A host of novel drug delivery systems that could stretch out intervals between injections are in human trials. In 2021, the FDA approved one such system, the refillable port delivery system (PDS) implant with ranibizumab (Susvimo). PDS is a small cylinder implanted into the eye and filled with 100 mg/mL of ranibizumab, to be released for 6 months or so, then refilled in the physician’s office when it’s empty.

But new implants of PDS were halted in 2022 after the manufacturer, Genentech, received reports the device leaked. Genentech said it has fixed those problems and confirmed the device should again become available for implants this year.

The most advanced novel drug delivery system in clinical trials is EYP-1901, a depot that contains the tyrosine kinase inhibitor (TKI) vorolanib. The depot is inserted under the ocular surface, where it biodegrades over 6 months as it releases the drug. A phase 3 trial is due to start enrollment at midyear.

An intravitreal implant with the TKI axitinib (Axpaxli) is in a phase 3 trial in nAMD and is due to start a phase 3 trial in diabetic retinopathy this year. At least four other implants, some of which biodegrade as they release the active ingredient, are in phase 1 or 2 trials.

TKIs themselves are a drug class worth watching in retina, said Jennifer I. Lim, MD, director of the retina service at the University of Illinois Chicago and president of the Retina Society.

“With TKIs, which activate intracellularly, in combination with anti-VEGFs will result in enhanced durability and possibly more efficacy for AMD,” Dr. Lim said. “TKIs in the phase 2 studies showed a marked reduction in the need for anti-VEGF injections in previously difficult-to-treat, high-need patient.”
 

Potential for Orals and Topicals

Topical eye drops are commonly used for anti-glaucoma drugs and antibiotics and corticosteroids for eye infections and inflammation, but using them for retinal disease has been a challenge. By the time the drug reaches the back of the eye, it has lost much of its pharmacokinetic activity. Three drops are in clinical trials for diabetic eye disease, with one, OCS-01, a preservative-free formulation of the corticosteroid dexamethasone, scheduled this year to enter a phase 3 trial.

At least four oral tablets are in early-stage human trials for diabetic eye disease. Four others are in clinical trials to treat geographic atrophy or early-stage dry AMD. They include tinlarebant, which is in phase 3 trials for geographic atrophy and Stargardt disease, an inherited retinal disorder.

Two other oral tablets are in human trials for inherited retinal disease. Like tinlarebant, emixustat has been in a phase 3 trial for Stargardt disease but showed no clinically significant improvement in macular atrophy. An early readout of an ongoing phase 2 trial of glideuretinol, a modified form of vitamin A, demonstrated slowed growth of macular atrophy in Stargardt.

These new and emerging treatments may potentially enable retina specialists to manage a rapidly growing aging population more efficiently, Dr. Sanders said.

“We have to figure out, on one hand, how do we catch the disease earlier? Like in other fields of medicine, the earlier you treat someone, the better,” Dr. Sanders said. “And also, how do we efficiently see these patients earlier to get therapy? Using implants or more durable drugs may be able to help us to treat more people more efficiently.”

Dr. Lim disclosed financial relationships with AbbVie/Allergan, Adverum Biotechnologies, Alimera Sciences, Bausch + Lomb, Chengdu Kanghong Biotechnology, Eyepoint Pharmaceuticals, Genentech/ Roche, Graybug Vision, Iveric Bio, Janssen Pharmaceuticals, Novartis, Regeneron Pharmaceuticals, RegenxBio, Santen, SparingVision, Stealth BioTherapeutics, Unity Biotechnology, and Viridian.

Dr. Boyer disclosed financial relationships with 4D Molecular Therapeutics, AbbVie/Allergan, Adverum Biotechnologies, Aldeyra Therapeutics, Alimera Sciences, Alkahest, Allegro, Amgen, Annexon Biosciences, Apellis Pharmaceuticals, AsclepiX Therapeutics, Aviceda Therapeutics, Bausch + Lomb, Bayer, Belite Bio, Clearside Biomedical, Eyepoint Pharmaceuticals, Genentech/ Roche, Graybug Vision, Iveric Bio, Janssen Pharmaceuticals, Nano scope Therapeutics, Novartis, Ocugen, Oculist, Ocuphire Pharma, Opthea, Pfizer, Regeneron Pharmaceuticals, RegenxBio, Sanofi, Stilbite Zhuhai, Stealth BioTherapeutics, Thea Laboratories, and Unity Biotechnology. Dr. Sanders had no relevant disclosures.
 

A version of this article appeared on Medscape.com.

The burdens that monthly or every-other-month injections in the eye impose on patients with retinal diseases are well-known to be barriers to care for many people with these conditions. Making treatment less onerous has driven research into new treatments since the US Food and Drug Administration (FDA) approved ranibizumab (Lucentis) in 2006 as the first anti–vascular endothelial growth factor (VEGF) for the treatment of age-related macular degeneration (AMD) and other retinal diseases.

Those new treatments include combination therapies, novel drug delivery systems, and a host of oral and topical medications to boost gains in visual acuity and extend the intervals between injections or avoid the injections altogether. Several of those investigational therapies are poised to hit meaningful milestones in 2024.
 

Regular Eye Injections: How We Got Here

Ranibizumab originally received approval as a monthly injection. Since then, protocols have evolved to space those injections out to every other month in some, but not all, patients.

New drugs have emerged that require less frequent injections. In 2022, the anti-VEGF and angiopoietin-2 inhibitor faricimab (Vabysmo) was approved for dosing up to every 4 months. Last year, the FDA approved a high-dose formulation of the anti-VEGF treatment aflibercept 8 mg (Eylea HD) to be given every 2-4 months, as well.

But even these treatments require patients going to the office at least three or four times a year for injections, Reginald Sanders, MD, president of the American Society of Retina Specialist, Chicago, and a retina specialist in Washington, DC, told this news organization. “Now with injections, you have the anxiety of getting the injections, you have the inconvenience of coming in on a regular basis to get the injections, and you have mild discomfort — but you don’t go blind,” Dr. Sanders said.

Studies have shown patients with AMD or diabetic macular edema are better off getting more frequent injections, but still drug developers are seeking the holy grail of fewer injections. “How do we make these treatments last longer?” Dr. Sanders said. “Durability has become the catchword in our field. Instead of lasting a month or 2, can it last 3 months? Can it last 6 months? Or even a year? Can you get one injection and be done with it?”

Or, no injection at all?

“We’re looking for incremental improvements and longer-acting drugs, trying to lengthen the time between injections for wet AMD patients,” said David Boyer, MD, a retina specialist in Los Angeles.
 

Two Drugs May Be Better Than One

One combination treatment, sozinibercept, targets VEGF-C and D. The therapy is in two phase 3 trials: One in combination with aflibercept 2 mg (Eylea), which targets VEGF-A and B along with placental growth factor, and the other in combination with ranibizumab, which targets VEGF-A only. Data from one of those trials are expected this year, Dr. Boyer said.

A phase 2 trial last year reported that patients on combination sozinibercept-ranibizumab had significantly better visual acuity improvement than patients on ranibizumab only. The phase 3 trials ShORe with ranibizumab and COAST with aflibercept are evaluating improvements in visual acuity and retinal anatomy.

Two other combination therapies are in phase 2 trials, both with aflibercept: UBX1325 or foselutoclax, a small-molecule inhibitor of B-cell lymphoma extra-large, and umedaptanib pegol, an anti-fibroblast growth factor-2 aptamer. In the foselutoclax-aflibercept trial, 40% of patients didn’t need a supplemental anti-VEGF injection through 48 weeks, and 64% went treatment-free for more than 24 weeks.

Phase 2 trials of intravitreal umedaptanib pegol-aflibercept combination therapy in nAMD last year showed no superiority in vision and anatomical improvements over aflibercept alone but did find the combination halted disease progression, with “striking improvement” in previously untreated patients.
 

Novel Drug Delivery Systems

A host of novel drug delivery systems that could stretch out intervals between injections are in human trials. In 2021, the FDA approved one such system, the refillable port delivery system (PDS) implant with ranibizumab (Susvimo). PDS is a small cylinder implanted into the eye and filled with 100 mg/mL of ranibizumab, to be released for 6 months or so, then refilled in the physician’s office when it’s empty.

But new implants of PDS were halted in 2022 after the manufacturer, Genentech, received reports the device leaked. Genentech said it has fixed those problems and confirmed the device should again become available for implants this year.

The most advanced novel drug delivery system in clinical trials is EYP-1901, a depot that contains the tyrosine kinase inhibitor (TKI) vorolanib. The depot is inserted under the ocular surface, where it biodegrades over 6 months as it releases the drug. A phase 3 trial is due to start enrollment at midyear.

An intravitreal implant with the TKI axitinib (Axpaxli) is in a phase 3 trial in nAMD and is due to start a phase 3 trial in diabetic retinopathy this year. At least four other implants, some of which biodegrade as they release the active ingredient, are in phase 1 or 2 trials.

TKIs themselves are a drug class worth watching in retina, said Jennifer I. Lim, MD, director of the retina service at the University of Illinois Chicago and president of the Retina Society.

“With TKIs, which activate intracellularly, in combination with anti-VEGFs will result in enhanced durability and possibly more efficacy for AMD,” Dr. Lim said. “TKIs in the phase 2 studies showed a marked reduction in the need for anti-VEGF injections in previously difficult-to-treat, high-need patient.”
 

Potential for Orals and Topicals

Topical eye drops are commonly used for anti-glaucoma drugs and antibiotics and corticosteroids for eye infections and inflammation, but using them for retinal disease has been a challenge. By the time the drug reaches the back of the eye, it has lost much of its pharmacokinetic activity. Three drops are in clinical trials for diabetic eye disease, with one, OCS-01, a preservative-free formulation of the corticosteroid dexamethasone, scheduled this year to enter a phase 3 trial.

At least four oral tablets are in early-stage human trials for diabetic eye disease. Four others are in clinical trials to treat geographic atrophy or early-stage dry AMD. They include tinlarebant, which is in phase 3 trials for geographic atrophy and Stargardt disease, an inherited retinal disorder.

Two other oral tablets are in human trials for inherited retinal disease. Like tinlarebant, emixustat has been in a phase 3 trial for Stargardt disease but showed no clinically significant improvement in macular atrophy. An early readout of an ongoing phase 2 trial of glideuretinol, a modified form of vitamin A, demonstrated slowed growth of macular atrophy in Stargardt.

These new and emerging treatments may potentially enable retina specialists to manage a rapidly growing aging population more efficiently, Dr. Sanders said.

“We have to figure out, on one hand, how do we catch the disease earlier? Like in other fields of medicine, the earlier you treat someone, the better,” Dr. Sanders said. “And also, how do we efficiently see these patients earlier to get therapy? Using implants or more durable drugs may be able to help us to treat more people more efficiently.”

Dr. Lim disclosed financial relationships with AbbVie/Allergan, Adverum Biotechnologies, Alimera Sciences, Bausch + Lomb, Chengdu Kanghong Biotechnology, Eyepoint Pharmaceuticals, Genentech/ Roche, Graybug Vision, Iveric Bio, Janssen Pharmaceuticals, Novartis, Regeneron Pharmaceuticals, RegenxBio, Santen, SparingVision, Stealth BioTherapeutics, Unity Biotechnology, and Viridian.

Dr. Boyer disclosed financial relationships with 4D Molecular Therapeutics, AbbVie/Allergan, Adverum Biotechnologies, Aldeyra Therapeutics, Alimera Sciences, Alkahest, Allegro, Amgen, Annexon Biosciences, Apellis Pharmaceuticals, AsclepiX Therapeutics, Aviceda Therapeutics, Bausch + Lomb, Bayer, Belite Bio, Clearside Biomedical, Eyepoint Pharmaceuticals, Genentech/ Roche, Graybug Vision, Iveric Bio, Janssen Pharmaceuticals, Nano scope Therapeutics, Novartis, Ocugen, Oculist, Ocuphire Pharma, Opthea, Pfizer, Regeneron Pharmaceuticals, RegenxBio, Sanofi, Stilbite Zhuhai, Stealth BioTherapeutics, Thea Laboratories, and Unity Biotechnology. Dr. Sanders had no relevant disclosures.
 

A version of this article appeared on Medscape.com.

The burdens that monthly or every-other-month injections in the eye impose on patients with retinal diseases are well-known to be barriers to care for many people with these conditions. Making treatment less onerous has driven research into new treatments since the US Food and Drug Administration (FDA) approved ranibizumab (Lucentis) in 2006 as the first anti–vascular endothelial growth factor (VEGF) for the treatment of age-related macular degeneration (AMD) and other retinal diseases.

Those new treatments include combination therapies, novel drug delivery systems, and a host of oral and topical medications to boost gains in visual acuity and extend the intervals between injections or avoid the injections altogether. Several of those investigational therapies are poised to hit meaningful milestones in 2024.
 

Regular Eye Injections: How We Got Here

Ranibizumab originally received approval as a monthly injection. Since then, protocols have evolved to space those injections out to every other month in some, but not all, patients.

New drugs have emerged that require less frequent injections. In 2022, the anti-VEGF and angiopoietin-2 inhibitor faricimab (Vabysmo) was approved for dosing up to every 4 months. Last year, the FDA approved a high-dose formulation of the anti-VEGF treatment aflibercept 8 mg (Eylea HD) to be given every 2-4 months, as well.

But even these treatments require patients going to the office at least three or four times a year for injections, Reginald Sanders, MD, president of the American Society of Retina Specialist, Chicago, and a retina specialist in Washington, DC, told this news organization. “Now with injections, you have the anxiety of getting the injections, you have the inconvenience of coming in on a regular basis to get the injections, and you have mild discomfort — but you don’t go blind,” Dr. Sanders said.

Studies have shown patients with AMD or diabetic macular edema are better off getting more frequent injections, but still drug developers are seeking the holy grail of fewer injections. “How do we make these treatments last longer?” Dr. Sanders said. “Durability has become the catchword in our field. Instead of lasting a month or 2, can it last 3 months? Can it last 6 months? Or even a year? Can you get one injection and be done with it?”

Or, no injection at all?

“We’re looking for incremental improvements and longer-acting drugs, trying to lengthen the time between injections for wet AMD patients,” said David Boyer, MD, a retina specialist in Los Angeles.
 

Two Drugs May Be Better Than One

One combination treatment, sozinibercept, targets VEGF-C and D. The therapy is in two phase 3 trials: One in combination with aflibercept 2 mg (Eylea), which targets VEGF-A and B along with placental growth factor, and the other in combination with ranibizumab, which targets VEGF-A only. Data from one of those trials are expected this year, Dr. Boyer said.

A phase 2 trial last year reported that patients on combination sozinibercept-ranibizumab had significantly better visual acuity improvement than patients on ranibizumab only. The phase 3 trials ShORe with ranibizumab and COAST with aflibercept are evaluating improvements in visual acuity and retinal anatomy.

Two other combination therapies are in phase 2 trials, both with aflibercept: UBX1325 or foselutoclax, a small-molecule inhibitor of B-cell lymphoma extra-large, and umedaptanib pegol, an anti-fibroblast growth factor-2 aptamer. In the foselutoclax-aflibercept trial, 40% of patients didn’t need a supplemental anti-VEGF injection through 48 weeks, and 64% went treatment-free for more than 24 weeks.

Phase 2 trials of intravitreal umedaptanib pegol-aflibercept combination therapy in nAMD last year showed no superiority in vision and anatomical improvements over aflibercept alone but did find the combination halted disease progression, with “striking improvement” in previously untreated patients.
 

Novel Drug Delivery Systems

A host of novel drug delivery systems that could stretch out intervals between injections are in human trials. In 2021, the FDA approved one such system, the refillable port delivery system (PDS) implant with ranibizumab (Susvimo). PDS is a small cylinder implanted into the eye and filled with 100 mg/mL of ranibizumab, to be released for 6 months or so, then refilled in the physician’s office when it’s empty.

But new implants of PDS were halted in 2022 after the manufacturer, Genentech, received reports the device leaked. Genentech said it has fixed those problems and confirmed the device should again become available for implants this year.

The most advanced novel drug delivery system in clinical trials is EYP-1901, a depot that contains the tyrosine kinase inhibitor (TKI) vorolanib. The depot is inserted under the ocular surface, where it biodegrades over 6 months as it releases the drug. A phase 3 trial is due to start enrollment at midyear.

An intravitreal implant with the TKI axitinib (Axpaxli) is in a phase 3 trial in nAMD and is due to start a phase 3 trial in diabetic retinopathy this year. At least four other implants, some of which biodegrade as they release the active ingredient, are in phase 1 or 2 trials.

TKIs themselves are a drug class worth watching in retina, said Jennifer I. Lim, MD, director of the retina service at the University of Illinois Chicago and president of the Retina Society.

“With TKIs, which activate intracellularly, in combination with anti-VEGFs will result in enhanced durability and possibly more efficacy for AMD,” Dr. Lim said. “TKIs in the phase 2 studies showed a marked reduction in the need for anti-VEGF injections in previously difficult-to-treat, high-need patient.”
 

Potential for Orals and Topicals

Topical eye drops are commonly used for anti-glaucoma drugs and antibiotics and corticosteroids for eye infections and inflammation, but using them for retinal disease has been a challenge. By the time the drug reaches the back of the eye, it has lost much of its pharmacokinetic activity. Three drops are in clinical trials for diabetic eye disease, with one, OCS-01, a preservative-free formulation of the corticosteroid dexamethasone, scheduled this year to enter a phase 3 trial.

At least four oral tablets are in early-stage human trials for diabetic eye disease. Four others are in clinical trials to treat geographic atrophy or early-stage dry AMD. They include tinlarebant, which is in phase 3 trials for geographic atrophy and Stargardt disease, an inherited retinal disorder.

Two other oral tablets are in human trials for inherited retinal disease. Like tinlarebant, emixustat has been in a phase 3 trial for Stargardt disease but showed no clinically significant improvement in macular atrophy. An early readout of an ongoing phase 2 trial of glideuretinol, a modified form of vitamin A, demonstrated slowed growth of macular atrophy in Stargardt.

These new and emerging treatments may potentially enable retina specialists to manage a rapidly growing aging population more efficiently, Dr. Sanders said.

“We have to figure out, on one hand, how do we catch the disease earlier? Like in other fields of medicine, the earlier you treat someone, the better,” Dr. Sanders said. “And also, how do we efficiently see these patients earlier to get therapy? Using implants or more durable drugs may be able to help us to treat more people more efficiently.”

Dr. Lim disclosed financial relationships with AbbVie/Allergan, Adverum Biotechnologies, Alimera Sciences, Bausch + Lomb, Chengdu Kanghong Biotechnology, Eyepoint Pharmaceuticals, Genentech/ Roche, Graybug Vision, Iveric Bio, Janssen Pharmaceuticals, Novartis, Regeneron Pharmaceuticals, RegenxBio, Santen, SparingVision, Stealth BioTherapeutics, Unity Biotechnology, and Viridian.

Dr. Boyer disclosed financial relationships with 4D Molecular Therapeutics, AbbVie/Allergan, Adverum Biotechnologies, Aldeyra Therapeutics, Alimera Sciences, Alkahest, Allegro, Amgen, Annexon Biosciences, Apellis Pharmaceuticals, AsclepiX Therapeutics, Aviceda Therapeutics, Bausch + Lomb, Bayer, Belite Bio, Clearside Biomedical, Eyepoint Pharmaceuticals, Genentech/ Roche, Graybug Vision, Iveric Bio, Janssen Pharmaceuticals, Nano scope Therapeutics, Novartis, Ocugen, Oculist, Ocuphire Pharma, Opthea, Pfizer, Regeneron Pharmaceuticals, RegenxBio, Sanofi, Stilbite Zhuhai, Stealth BioTherapeutics, Thea Laboratories, and Unity Biotechnology. Dr. Sanders had no relevant disclosures.
 

A version of this article appeared on Medscape.com.

Patients with rheumatoid arthritis (RA) whose symptoms improved after they started taking nonbiologic disease-modifying antirheumatic drugs also demonstrated restored balance in their oral and gut flora, which could potentially serve as a marker of how they’ll respond to DMARDs, an observational study in the United Kingdom found.

Reporting in the journal Rheumatology, researchers led by Nathan Danckert, PhD, a genetic epidemiology researcher at King’s College London, and Maxim Freidin, PhD, of the Queen Mary University of London, London, England, evaluated stool and saliva samples of 144 people recently diagnosed with RA before and after they started DMARD therapy.

microbiome_gut_web.jpg

“We identified a partial restoration of the microbiome to a more eubiotic state in RA patients at 6 weeks and 12 weeks of DMARD treatment in participants [who] responded well to DMARD therapy,” they wrote. “This was further supported by long-term (> 1 year) treated DMARD RA participants with similar community shifts.” Microbiomes, they said, are “a promising diagnostic tool” for directing DMARD therapy.
 

Study Goal Not Met

The goal of the study was to determine whether the microbiome of patients before they began treatment with DMARDs could predict their response to therapy. The patients were enrolled in the IMRABIOME study. Eligible patients had inflammatory arthritis symptoms for a year or less and met the clinical criteria for RA. Most patients were taking methotrexate (134 at baseline, 77 at 12 weeks), but study participants were also taking sulfasalazine (16 at baseline, 14 at 12 weeks) or hydroxychloroquine (58 at baseline, 45 at 12 weeks) either in combination or as a stand-alone treatment.

The study found a total of 26 different stool microbes that decreased in patients who had a minimal clinically important improvement (MCII) after starting DMARD therapy. At 6 weeks, the most significant declines were in Prevotella species. At 12 weeks, the greatest declines were in Streptococcus. 

The researchers also developed models that used gut and oral metagenomes to predict MCII in patients starting DMARD therapy. They used a previously published microbiome dataset as a validation cohort for the model, but they acknowledged their models “were not as strong” as three previously published models. “Our findings support the hypothesis of DMARD restoration of a eubiotic gut microbiome when patient and treatment align,” the authors wrote.

They noted they had anticipated finding baseline microbiome samples that would help predict treatment responses. While baseline evaluation didn’t differentiate between responders and nonresponders, they wrote that a longitudinal analysis demonstrated changing microbiota and a positive response to therapy, with declining levels of Prevotella and Streptococcus species most pronounced at 6 and 12 weeks, respectively.

“Microbiomes provide a promising diagnostic tool for guiding therapeutic decisions in the future,” the study authors wrote.
 

Commentary

In commenting on the study, Gregg J. Silverman, MD, professor of medicine and pathology at the New York University School of Medicine, New York City, said it “was carefully performed, technically it was actually quite impressive, and the scale of the study actually was quite suitable.”

Silverman_Gregg_NY_2_web.jpg

However, the study fell short of achieving its primary goal of using the microbiome to predict treatment response, he said. “Basically, they could not find there was anything they could correlate with clinical response rates, although they did find that the presence or absence of certain bacteria at 6 weeks or 12 weeks into treatment correlated with a clinical response,” he said.

The multiplicity of DMARDs used by the study population was “one of the complicating factors” of the study, Dr. Silverman said. “It would’ve been a much more easily interpreted study if it used just a single agent like methotrexate,” he said. “I think that’s problematic, but I do think this contributes to getting us a little further down the road of understanding how the microbiome can influence the pathogenesis of rheumatoid arthritis response to treatment.”

One of the questions surrounding the microbiome changes is whether they occurred because of the effect of the therapy itself or because the disease activity subsides, Dr. Silverman said. “So, you’re not sure if it’s cause or effect. There’s evidence to suggest that either could be true.”

This study adds to a 2022 study that found a similar effect with methotrexate, Dr. Silverman said. “They considered a lot of variables, and they considered a lot of potential confounding effects,” he said. “So, their data were well-considered, and they will actually hold up over time and contribute to the next range of studies that will be performed, no doubt, in this area.”

It would be better if those future studies focused on just one DMARD drug and studied the recovered bacteria in animal models to gain a better understanding of how they correlate to pathogenesis, Dr. Silverman added.

The study received funding from Versus Arthritis. Dr. Danckert, Dr. Freidin, and coauthors, as well as Dr. Silverman, reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

Patients with rheumatoid arthritis (RA) whose symptoms improved after they started taking nonbiologic disease-modifying antirheumatic drugs also demonstrated restored balance in their oral and gut flora, which could potentially serve as a marker of how they’ll respond to DMARDs, an observational study in the United Kingdom found.

Reporting in the journal Rheumatology, researchers led by Nathan Danckert, PhD, a genetic epidemiology researcher at King’s College London, and Maxim Freidin, PhD, of the Queen Mary University of London, London, England, evaluated stool and saliva samples of 144 people recently diagnosed with RA before and after they started DMARD therapy.

microbiome_gut_web.jpg

“We identified a partial restoration of the microbiome to a more eubiotic state in RA patients at 6 weeks and 12 weeks of DMARD treatment in participants [who] responded well to DMARD therapy,” they wrote. “This was further supported by long-term (> 1 year) treated DMARD RA participants with similar community shifts.” Microbiomes, they said, are “a promising diagnostic tool” for directing DMARD therapy.
 

Study Goal Not Met

The goal of the study was to determine whether the microbiome of patients before they began treatment with DMARDs could predict their response to therapy. The patients were enrolled in the IMRABIOME study. Eligible patients had inflammatory arthritis symptoms for a year or less and met the clinical criteria for RA. Most patients were taking methotrexate (134 at baseline, 77 at 12 weeks), but study participants were also taking sulfasalazine (16 at baseline, 14 at 12 weeks) or hydroxychloroquine (58 at baseline, 45 at 12 weeks) either in combination or as a stand-alone treatment.

The study found a total of 26 different stool microbes that decreased in patients who had a minimal clinically important improvement (MCII) after starting DMARD therapy. At 6 weeks, the most significant declines were in Prevotella species. At 12 weeks, the greatest declines were in Streptococcus. 

The researchers also developed models that used gut and oral metagenomes to predict MCII in patients starting DMARD therapy. They used a previously published microbiome dataset as a validation cohort for the model, but they acknowledged their models “were not as strong” as three previously published models. “Our findings support the hypothesis of DMARD restoration of a eubiotic gut microbiome when patient and treatment align,” the authors wrote.

They noted they had anticipated finding baseline microbiome samples that would help predict treatment responses. While baseline evaluation didn’t differentiate between responders and nonresponders, they wrote that a longitudinal analysis demonstrated changing microbiota and a positive response to therapy, with declining levels of Prevotella and Streptococcus species most pronounced at 6 and 12 weeks, respectively.

“Microbiomes provide a promising diagnostic tool for guiding therapeutic decisions in the future,” the study authors wrote.
 

Commentary

In commenting on the study, Gregg J. Silverman, MD, professor of medicine and pathology at the New York University School of Medicine, New York City, said it “was carefully performed, technically it was actually quite impressive, and the scale of the study actually was quite suitable.”

Silverman_Gregg_NY_2_web.jpg

However, the study fell short of achieving its primary goal of using the microbiome to predict treatment response, he said. “Basically, they could not find there was anything they could correlate with clinical response rates, although they did find that the presence or absence of certain bacteria at 6 weeks or 12 weeks into treatment correlated with a clinical response,” he said.

The multiplicity of DMARDs used by the study population was “one of the complicating factors” of the study, Dr. Silverman said. “It would’ve been a much more easily interpreted study if it used just a single agent like methotrexate,” he said. “I think that’s problematic, but I do think this contributes to getting us a little further down the road of understanding how the microbiome can influence the pathogenesis of rheumatoid arthritis response to treatment.”

One of the questions surrounding the microbiome changes is whether they occurred because of the effect of the therapy itself or because the disease activity subsides, Dr. Silverman said. “So, you’re not sure if it’s cause or effect. There’s evidence to suggest that either could be true.”

This study adds to a 2022 study that found a similar effect with methotrexate, Dr. Silverman said. “They considered a lot of variables, and they considered a lot of potential confounding effects,” he said. “So, their data were well-considered, and they will actually hold up over time and contribute to the next range of studies that will be performed, no doubt, in this area.”

It would be better if those future studies focused on just one DMARD drug and studied the recovered bacteria in animal models to gain a better understanding of how they correlate to pathogenesis, Dr. Silverman added.

The study received funding from Versus Arthritis. Dr. Danckert, Dr. Freidin, and coauthors, as well as Dr. Silverman, reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

Patients with rheumatoid arthritis (RA) whose symptoms improved after they started taking nonbiologic disease-modifying antirheumatic drugs also demonstrated restored balance in their oral and gut flora, which could potentially serve as a marker of how they’ll respond to DMARDs, an observational study in the United Kingdom found.

Reporting in the journal Rheumatology, researchers led by Nathan Danckert, PhD, a genetic epidemiology researcher at King’s College London, and Maxim Freidin, PhD, of the Queen Mary University of London, London, England, evaluated stool and saliva samples of 144 people recently diagnosed with RA before and after they started DMARD therapy.

microbiome_gut_web.jpg

“We identified a partial restoration of the microbiome to a more eubiotic state in RA patients at 6 weeks and 12 weeks of DMARD treatment in participants [who] responded well to DMARD therapy,” they wrote. “This was further supported by long-term (> 1 year) treated DMARD RA participants with similar community shifts.” Microbiomes, they said, are “a promising diagnostic tool” for directing DMARD therapy.
 

Study Goal Not Met

The goal of the study was to determine whether the microbiome of patients before they began treatment with DMARDs could predict their response to therapy. The patients were enrolled in the IMRABIOME study. Eligible patients had inflammatory arthritis symptoms for a year or less and met the clinical criteria for RA. Most patients were taking methotrexate (134 at baseline, 77 at 12 weeks), but study participants were also taking sulfasalazine (16 at baseline, 14 at 12 weeks) or hydroxychloroquine (58 at baseline, 45 at 12 weeks) either in combination or as a stand-alone treatment.

The study found a total of 26 different stool microbes that decreased in patients who had a minimal clinically important improvement (MCII) after starting DMARD therapy. At 6 weeks, the most significant declines were in Prevotella species. At 12 weeks, the greatest declines were in Streptococcus. 

The researchers also developed models that used gut and oral metagenomes to predict MCII in patients starting DMARD therapy. They used a previously published microbiome dataset as a validation cohort for the model, but they acknowledged their models “were not as strong” as three previously published models. “Our findings support the hypothesis of DMARD restoration of a eubiotic gut microbiome when patient and treatment align,” the authors wrote.

They noted they had anticipated finding baseline microbiome samples that would help predict treatment responses. While baseline evaluation didn’t differentiate between responders and nonresponders, they wrote that a longitudinal analysis demonstrated changing microbiota and a positive response to therapy, with declining levels of Prevotella and Streptococcus species most pronounced at 6 and 12 weeks, respectively.

“Microbiomes provide a promising diagnostic tool for guiding therapeutic decisions in the future,” the study authors wrote.
 

Commentary

In commenting on the study, Gregg J. Silverman, MD, professor of medicine and pathology at the New York University School of Medicine, New York City, said it “was carefully performed, technically it was actually quite impressive, and the scale of the study actually was quite suitable.”

Silverman_Gregg_NY_2_web.jpg

However, the study fell short of achieving its primary goal of using the microbiome to predict treatment response, he said. “Basically, they could not find there was anything they could correlate with clinical response rates, although they did find that the presence or absence of certain bacteria at 6 weeks or 12 weeks into treatment correlated with a clinical response,” he said.

The multiplicity of DMARDs used by the study population was “one of the complicating factors” of the study, Dr. Silverman said. “It would’ve been a much more easily interpreted study if it used just a single agent like methotrexate,” he said. “I think that’s problematic, but I do think this contributes to getting us a little further down the road of understanding how the microbiome can influence the pathogenesis of rheumatoid arthritis response to treatment.”

One of the questions surrounding the microbiome changes is whether they occurred because of the effect of the therapy itself or because the disease activity subsides, Dr. Silverman said. “So, you’re not sure if it’s cause or effect. There’s evidence to suggest that either could be true.”

This study adds to a 2022 study that found a similar effect with methotrexate, Dr. Silverman said. “They considered a lot of variables, and they considered a lot of potential confounding effects,” he said. “So, their data were well-considered, and they will actually hold up over time and contribute to the next range of studies that will be performed, no doubt, in this area.”

It would be better if those future studies focused on just one DMARD drug and studied the recovered bacteria in animal models to gain a better understanding of how they correlate to pathogenesis, Dr. Silverman added.

The study received funding from Versus Arthritis. Dr. Danckert, Dr. Freidin, and coauthors, as well as Dr. Silverman, reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

Prednisolone may be an effective bridge therapy to ease withdrawal symptoms and improve reversal for patients with migraine whose headaches persist despite them taking an abundance of acute headache medications, a condition known as medication-overuse headache (MOH), an observational study out of South Korea has found.

The study, a post-hoc analysis of the RELEASE multicenter observational cohort study of MOH patients in South Korea, found that patients who took prednisolone as a bridge therapy in the early phase of withdrawal from headache medications, or detoxification, had statistically significant higher rates of MOH reversal at 3 months after enrollment than those who did not, 73.8% versus 57.8% (P = .034)  

Lee_Mi Ji_Seoul_web.jpg

The reversal trend also was noted at 1 month after treatment, the study authors, led by Mi Ji Lee, MD, PhD, an assistant professor at Seoul National University Hospital, Seoul, South Korea, wrote. “Although an observational study cannot draw a definitive conclusion, our study supports the use of prednisolone for the treatment of MOH in a real-world setting,” Dr. Lee and colleagues wrote.
 

Study methods

The study was a post hoc analysis of the RELEASE study, which stands for Registry for Load and Management of Medication Overuse Headache. RELEASE is a multicenter observational cohort study that has been ongoing in South Korea since April 2020. The post hoc analysis included 309 patients, 59 of whom received prednisolone at a varying dose of 10-40 mg a day, with a varying course of 5-14 days. About 74% of patients (228 of 309) completed the 3-month follow-up period, including 41 in the prednisolone group.

The study used three different forms of medication withdrawal before the patients started prednisolone therapy: abrupt discontinuation; gradual discontinuation concurrent with starting prednisolone; and no withdrawal.

Because of the observational nature of the RELEASE study, participating physicians prescribed prednisolone at their own discretion. The study authors noted prednisolone use was neither randomized nor controlled, which they acknowledged as a limitation.

Dr. Lee and colleagues also acknowledged that newer calcitonin gene–related peptide (CGRP) receptor antagonists may not require detoxification to reverse MOH, but that those therapies are not always available for a variety of reasons, such as reimbursement restrictions, regional distribution issues, and financial issues.

The study also evaluated a number of secondary outcomes. For example, 72% of prednisolone patients achieved MOH reversal 1 month after starting treatment versus 54.9% of the nonprednisolone patients. (P = .33). Prednisolone users also had greater reductions in acute medication days (AMD) at 1 month and scores on headache impact test-6 (HIT-6) at 6 months.

Dr. Lee and colleagues noted that the concept of detoxification, or discontinuing medication overuse, as a treatment for MOH has been controversial due to a lack of high-quality evidence to support the approach. “Nevertheless,” they wrote, “several experts still put withdrawal of medication overuse as an important step of MOH treatment in clinical practice despite limited evidence.”
 

Commentary

Alan Rapoport, MD, a clinical professor of neurology at the David Geffen School of Medicine at University of California, Los Angeles, noted a number of limitations with the study. “It wasn’t a unified population of patients,” he said, “which makes it a little harder to say this medicine worked — worked on whom?” The lack of a treatment regimen — the varied dosing and treatment durations, along with the different withdrawal approaches — are further limitations, Dr. Rapoport said.

Rapoport_Alan_LA_web.jpg

Nonetheless, the study is an important addition to the evidence on how to manage medication withdrawal in MOH, said Dr. Rapoport, a past president of the International Headache Society and founder and director emeritus of the New England Center for Headache in Stamford, Connecticut, who has a keen interest in MOH research.

“I think this shows to some extent, although it doesn’t prove it because it’s a whole mixture of patients who were all treated differently by different doctors, but when you put them all together the patients who took steroids did better than the patients who did not,” he said. “The study authors did the best they could with the information they had.”

He termed the study “well-done by well-known authors in South Korea.” As medications such as CGRP receptor antagonists and monoclonal antibodies that target CGRP and its receptors become more available, MOH patients “may not need actual detoxification or steroids in their treatment,” Dr. Rapoport said.

Dr. Lee and co-authors have no disclosures. Dr. Rapoport is editor-in-chief of Neurology Reviews. He disclosed relationships with AbbVie, Biohaven, Cala Health, Dr. Reddy’s, Pfizer, Satsuma, Teva Pharmaceutical Industries, and Theranica.

Prednisolone may be an effective bridge therapy to ease withdrawal symptoms and improve reversal for patients with migraine whose headaches persist despite them taking an abundance of acute headache medications, a condition known as medication-overuse headache (MOH), an observational study out of South Korea has found.

The study, a post-hoc analysis of the RELEASE multicenter observational cohort study of MOH patients in South Korea, found that patients who took prednisolone as a bridge therapy in the early phase of withdrawal from headache medications, or detoxification, had statistically significant higher rates of MOH reversal at 3 months after enrollment than those who did not, 73.8% versus 57.8% (P = .034)  

Lee_Mi Ji_Seoul_web.jpg

The reversal trend also was noted at 1 month after treatment, the study authors, led by Mi Ji Lee, MD, PhD, an assistant professor at Seoul National University Hospital, Seoul, South Korea, wrote. “Although an observational study cannot draw a definitive conclusion, our study supports the use of prednisolone for the treatment of MOH in a real-world setting,” Dr. Lee and colleagues wrote.
 

Study methods

The study was a post hoc analysis of the RELEASE study, which stands for Registry for Load and Management of Medication Overuse Headache. RELEASE is a multicenter observational cohort study that has been ongoing in South Korea since April 2020. The post hoc analysis included 309 patients, 59 of whom received prednisolone at a varying dose of 10-40 mg a day, with a varying course of 5-14 days. About 74% of patients (228 of 309) completed the 3-month follow-up period, including 41 in the prednisolone group.

The study used three different forms of medication withdrawal before the patients started prednisolone therapy: abrupt discontinuation; gradual discontinuation concurrent with starting prednisolone; and no withdrawal.

Because of the observational nature of the RELEASE study, participating physicians prescribed prednisolone at their own discretion. The study authors noted prednisolone use was neither randomized nor controlled, which they acknowledged as a limitation.

Dr. Lee and colleagues also acknowledged that newer calcitonin gene–related peptide (CGRP) receptor antagonists may not require detoxification to reverse MOH, but that those therapies are not always available for a variety of reasons, such as reimbursement restrictions, regional distribution issues, and financial issues.

The study also evaluated a number of secondary outcomes. For example, 72% of prednisolone patients achieved MOH reversal 1 month after starting treatment versus 54.9% of the nonprednisolone patients. (P = .33). Prednisolone users also had greater reductions in acute medication days (AMD) at 1 month and scores on headache impact test-6 (HIT-6) at 6 months.

Dr. Lee and colleagues noted that the concept of detoxification, or discontinuing medication overuse, as a treatment for MOH has been controversial due to a lack of high-quality evidence to support the approach. “Nevertheless,” they wrote, “several experts still put withdrawal of medication overuse as an important step of MOH treatment in clinical practice despite limited evidence.”
 

Commentary

Alan Rapoport, MD, a clinical professor of neurology at the David Geffen School of Medicine at University of California, Los Angeles, noted a number of limitations with the study. “It wasn’t a unified population of patients,” he said, “which makes it a little harder to say this medicine worked — worked on whom?” The lack of a treatment regimen — the varied dosing and treatment durations, along with the different withdrawal approaches — are further limitations, Dr. Rapoport said.

Rapoport_Alan_LA_web.jpg

Nonetheless, the study is an important addition to the evidence on how to manage medication withdrawal in MOH, said Dr. Rapoport, a past president of the International Headache Society and founder and director emeritus of the New England Center for Headache in Stamford, Connecticut, who has a keen interest in MOH research.

“I think this shows to some extent, although it doesn’t prove it because it’s a whole mixture of patients who were all treated differently by different doctors, but when you put them all together the patients who took steroids did better than the patients who did not,” he said. “The study authors did the best they could with the information they had.”

He termed the study “well-done by well-known authors in South Korea.” As medications such as CGRP receptor antagonists and monoclonal antibodies that target CGRP and its receptors become more available, MOH patients “may not need actual detoxification or steroids in their treatment,” Dr. Rapoport said.

Dr. Lee and co-authors have no disclosures. Dr. Rapoport is editor-in-chief of Neurology Reviews. He disclosed relationships with AbbVie, Biohaven, Cala Health, Dr. Reddy’s, Pfizer, Satsuma, Teva Pharmaceutical Industries, and Theranica.

Prednisolone may be an effective bridge therapy to ease withdrawal symptoms and improve reversal for patients with migraine whose headaches persist despite them taking an abundance of acute headache medications, a condition known as medication-overuse headache (MOH), an observational study out of South Korea has found.

The study, a post-hoc analysis of the RELEASE multicenter observational cohort study of MOH patients in South Korea, found that patients who took prednisolone as a bridge therapy in the early phase of withdrawal from headache medications, or detoxification, had statistically significant higher rates of MOH reversal at 3 months after enrollment than those who did not, 73.8% versus 57.8% (P = .034)  

Lee_Mi Ji_Seoul_web.jpg

The reversal trend also was noted at 1 month after treatment, the study authors, led by Mi Ji Lee, MD, PhD, an assistant professor at Seoul National University Hospital, Seoul, South Korea, wrote. “Although an observational study cannot draw a definitive conclusion, our study supports the use of prednisolone for the treatment of MOH in a real-world setting,” Dr. Lee and colleagues wrote.
 

Study methods

The study was a post hoc analysis of the RELEASE study, which stands for Registry for Load and Management of Medication Overuse Headache. RELEASE is a multicenter observational cohort study that has been ongoing in South Korea since April 2020. The post hoc analysis included 309 patients, 59 of whom received prednisolone at a varying dose of 10-40 mg a day, with a varying course of 5-14 days. About 74% of patients (228 of 309) completed the 3-month follow-up period, including 41 in the prednisolone group.

The study used three different forms of medication withdrawal before the patients started prednisolone therapy: abrupt discontinuation; gradual discontinuation concurrent with starting prednisolone; and no withdrawal.

Because of the observational nature of the RELEASE study, participating physicians prescribed prednisolone at their own discretion. The study authors noted prednisolone use was neither randomized nor controlled, which they acknowledged as a limitation.

Dr. Lee and colleagues also acknowledged that newer calcitonin gene–related peptide (CGRP) receptor antagonists may not require detoxification to reverse MOH, but that those therapies are not always available for a variety of reasons, such as reimbursement restrictions, regional distribution issues, and financial issues.

The study also evaluated a number of secondary outcomes. For example, 72% of prednisolone patients achieved MOH reversal 1 month after starting treatment versus 54.9% of the nonprednisolone patients. (P = .33). Prednisolone users also had greater reductions in acute medication days (AMD) at 1 month and scores on headache impact test-6 (HIT-6) at 6 months.

Dr. Lee and colleagues noted that the concept of detoxification, or discontinuing medication overuse, as a treatment for MOH has been controversial due to a lack of high-quality evidence to support the approach. “Nevertheless,” they wrote, “several experts still put withdrawal of medication overuse as an important step of MOH treatment in clinical practice despite limited evidence.”
 

Commentary

Alan Rapoport, MD, a clinical professor of neurology at the David Geffen School of Medicine at University of California, Los Angeles, noted a number of limitations with the study. “It wasn’t a unified population of patients,” he said, “which makes it a little harder to say this medicine worked — worked on whom?” The lack of a treatment regimen — the varied dosing and treatment durations, along with the different withdrawal approaches — are further limitations, Dr. Rapoport said.

Rapoport_Alan_LA_web.jpg

Nonetheless, the study is an important addition to the evidence on how to manage medication withdrawal in MOH, said Dr. Rapoport, a past president of the International Headache Society and founder and director emeritus of the New England Center for Headache in Stamford, Connecticut, who has a keen interest in MOH research.

“I think this shows to some extent, although it doesn’t prove it because it’s a whole mixture of patients who were all treated differently by different doctors, but when you put them all together the patients who took steroids did better than the patients who did not,” he said. “The study authors did the best they could with the information they had.”

He termed the study “well-done by well-known authors in South Korea.” As medications such as CGRP receptor antagonists and monoclonal antibodies that target CGRP and its receptors become more available, MOH patients “may not need actual detoxification or steroids in their treatment,” Dr. Rapoport said.

Dr. Lee and co-authors have no disclosures. Dr. Rapoport is editor-in-chief of Neurology Reviews. He disclosed relationships with AbbVie, Biohaven, Cala Health, Dr. Reddy’s, Pfizer, Satsuma, Teva Pharmaceutical Industries, and Theranica.

Dry eye and glaucoma may be the two most confounding conditions ophthalmologists face. Late last year, the US Food and Drug Administration (FDA) approved three new treatments for dry eye disease (DED) and one new procedure for glaucoma, which means ophthalmologists will soon have the opportunity to incorporate these therapies into their practices. Meanwhile, several investigative treatments for both chronic ailments will continue to move forward.

Undry Those Eyes

Based on a 2022 study in JAMA Ophthalmology, about 27 million Americans have some form of DED or meibomian gland dysfunction. Treatments aim to preserve and enhance tears and tear production to counteract the grittiness and itchiness that accompany DED.

“For decades, we only had one treatment [cyclosporine] for dry eye, then the second one a few years ago, which is lifitegrast, but nothing innovative until very recently,” Marjan Farid, MD, director of cornea, cataract and refractive surgery at the Gavin Herbert Eye Institute at the University of California-Irvine, told this news organization.

“In 2023, I feel that innovation from the pharmaceutical standpoint in this space really exploded, and it’s very exciting because dry eye disease is such a multifactorial disease that you can’t just go after one angle,” said Dr. Farid, who is also chair of the American Society of Cataract and Refractive Surgery’s cornea clinical committee. “You really need to be able to attack dry eye disease from multiple areas, when the meibomian glands are involved, or whether or not there’s blephartitis.”

The three treatments for DED the FDA approved last year are lotilaner 0.25% ophthalmic solution, which targets the Demodex mites that cause of Demodex blepharitis, a trigger for DED; perfluorohexyloctane ophthalmic solution; and cyclosporine ophthalmic solution 0.1%. The latter two agents coat the ocular surface — perfluorohexyloctane acting as a shield to prevent tear evaporation and cyclosporine 0.1% using perfluorobutylpentane to allow the immunosuppressant cyclosporine to penetrate deeper into the eye.

This year, Dr. Farid said, while ophthalmologists will be adopting those treatments, they’ll also be watching three emerging treatments poised to report results from clinical trial or take other steps toward FDA approval. They include:

• Selenium sulfide 0.5% ophthalmic ointment will move into phase 3 trials. This ointment is applied directly to the lower eyelid to open the meibomian gland (MGs), secretions from which prevent tear evaporation and tear overflow. Results last year from a phase 2 trial demonstrated improvement in MG secretions in treated patients. “It’s a very unique compound because it’s the only compound that could potentially open the meibomian gland orifices along lid margin and improve the quality of secretions,” Dr. Farid said.
• Reproxalap, a reactive aldehyde species (RASP) inhibitor, will be the subject of a new drug application (NDA) resubmission this year. RASPs have been found in elevated levels in ocular and systemic inflammatory disease. The FDA last year notified drug developer Aldeyra Therapeutics that an additional trial was needed to demonstrate efficacy in treating symptoms of DED. Aldeyra said it would resubmit the NDA and report topline trial results in the first half of the year. “That’s a really nice anti-inflammatory eye drop that works early in the inflammatory cascade,” Dr. Farid said. “It acts almost like a steroid does without having the side effects of the steroid.”
• AR-15512, a topical transient receptor potential melastatin 8 agonist, may also be the subject of an NDA this year. Topline results from two phase 3 trials last year demonstrated a clinically meaningful increase in tear production.

The Centers for Disease Control and Prevention estimates 3 million Americans have glaucoma. The use of daily eye drops to lower intraocular pressure (IOP) has been a mainstay of glaucoma therapy treatment for decades. However, a 2018 study put the rates of nonadherence as high at 67%.

In part to skirt the adherence issue, several approaches have evolved to lower IOP without relying on drops. They include laser treatments to perforate the eye’s trabecular meshwork and improve the outflow of aqueous humor, minimally invasive glaucoma surgery to create a small tunnel or even insert a shunt to enable aqueous outflow, and, more recently, implantable depots that release IOP-lowering drugs within the eye over months.

“Glaucoma is a disease that has a slow onset, so you have to diagnose it as early as possible,” Andrew Iwach, MD, a glaucoma specialist in San Francisco and clinical spokesperson for the American Academy of Ophthalmology, told this news organization. “One challenge with glaucoma is its chronic nature. There are different methods that are being looked at to achieve sustained release of drugs — ways you can implant a little bolus of this medicine,” Dr. Iwach added.

Glaucoma also requires regular monitoring of changes in IOP, Iwach noted. “During COVID, there was an increased interest in during this remotely,” he said. A remote monitoring platform, Peripherex, was registered last year with the FDA. It consists of a diagnostic online visual field test that can enable patients with glaucoma to provide data on disease changes from home.

A laser platform, the Belkin Eagle Nd:YAG laser for performing selective laser trabeculoplasty (SLT), in December 2023 received FDA clearance. Dr. Iwach said this is the first innovation in lasers in 20 years in that it eliminates the need for placing a diagnostic lens on the eye itself to direct the laser pulses, a technique called direct SLT. It uses a computer-driven tacking device.

Looking Ahead

A laser in development is ViaLase, which offers femtosecond laser image-guided high-precision trabeculotomy or FLigHT. The VIA-002 study, which began enrolling patients in September 2023, is comparing ViaLase with SLT to determine reduction in unmedicated IOP at 6 and 12 months. A small feasibility study published last year demonstrated safety of the procedure with an average reduction in IOP of 34.6% at 24 months.

Microshunts inserted into the eye also have been used to reduce IOP. An early stage study is evaluating a new-generation, minimally invasive shunt that, once implanted, allows the ophthalmologist to adjust the level of aqueous outflow in an office-based procedure.

Another December 2023 FDA approval was iDose TR, an implant loaded with the prostaglandin analog travoprost 75 mcg. The implant is scheduled for commercial release in the first quarter of 2024, with a projected wholesale acquisition cost of $13,950 per dose or implant.

Two phase 3 trials compared two iDose TR models with two different travoprost release intervals, defined as the fast- and slow-release iDose TR models, respectively, with topical timolol ophthalmic solution, 0.5% twice a day. The trials demonstrated comparable IOP reduction between all three vehicles. At 12 months, 81% of iDose TR subjects required no IOP-lowering topical medications across both trials.

Also in development is an implant that uses a cilioscleral technique to preserve the anterior chamber of the eye, reducing the risk for complications, such as endothelial cell loss or a filtration bleb, that can occur with other implant procedures. Preliminary results of a 12-month study of 57 patients fitted with a new design with the cilioscleral interpositioning device (CID) showed it lowered IOP an average of 13.9 mmHg vs 15.1 mmHg in earlier studies with the device. In the latest study, more than 85% of patients reported being medication free at 12 months. The CID procedure spares the conjunctiva, requiring only a local incision, according to its developers.

As for topical agents that reduce IOP, cannabinoids may soon find their way into the glaucoma specialist’s toolbox. A phase 2 trial evaluating SBI-100 ophthalmic emulsion started enrolling patients late last year. SBI-100 OE is a synthetic prodrug of tetrahydrocannabinol that can bind and activate cannabinoid receptor type 1 in ocular tissues. The trial is scheduled for completion later this year. A phase 1 trial last year demonstrated an average reduction in IOP of 24%.

Another area of focus is on the use of preservatives in topical drops. “One of big issues we’re dealing with is preservatives because you’re marinating these eyes over years with these drops,” Dr. Iwach said. Late last year, the first preservative-free form of latanoprost ophthalmic solution 0.005% launched in the United States. Other delivery systems that remove preservatives from topical drops and preservative-free formulations are in the investigative stage, he said.

Dr. Farid disclosed financial relationships with Alcon Laboratories, Allergan/AbbVie, Bausch + Lomb, Bio-Tissue, CorneaGen, Harrow, Kala Pharmaceuticals, and Tarsus Pharmaceuticals. Dr. Iwach disclosed a previous financial relationship with Belkin Vision as well as relationships with Alcon Laboratories and Innovia.

A version of this article appeared on Medscape.com.

Dry eye and glaucoma may be the two most confounding conditions ophthalmologists face. Late last year, the US Food and Drug Administration (FDA) approved three new treatments for dry eye disease (DED) and one new procedure for glaucoma, which means ophthalmologists will soon have the opportunity to incorporate these therapies into their practices. Meanwhile, several investigative treatments for both chronic ailments will continue to move forward.

Undry Those Eyes

Based on a 2022 study in JAMA Ophthalmology, about 27 million Americans have some form of DED or meibomian gland dysfunction. Treatments aim to preserve and enhance tears and tear production to counteract the grittiness and itchiness that accompany DED.

“For decades, we only had one treatment [cyclosporine] for dry eye, then the second one a few years ago, which is lifitegrast, but nothing innovative until very recently,” Marjan Farid, MD, director of cornea, cataract and refractive surgery at the Gavin Herbert Eye Institute at the University of California-Irvine, told this news organization.

“In 2023, I feel that innovation from the pharmaceutical standpoint in this space really exploded, and it’s very exciting because dry eye disease is such a multifactorial disease that you can’t just go after one angle,” said Dr. Farid, who is also chair of the American Society of Cataract and Refractive Surgery’s cornea clinical committee. “You really need to be able to attack dry eye disease from multiple areas, when the meibomian glands are involved, or whether or not there’s blephartitis.”

The three treatments for DED the FDA approved last year are lotilaner 0.25% ophthalmic solution, which targets the Demodex mites that cause of Demodex blepharitis, a trigger for DED; perfluorohexyloctane ophthalmic solution; and cyclosporine ophthalmic solution 0.1%. The latter two agents coat the ocular surface — perfluorohexyloctane acting as a shield to prevent tear evaporation and cyclosporine 0.1% using perfluorobutylpentane to allow the immunosuppressant cyclosporine to penetrate deeper into the eye.

This year, Dr. Farid said, while ophthalmologists will be adopting those treatments, they’ll also be watching three emerging treatments poised to report results from clinical trial or take other steps toward FDA approval. They include:

• Selenium sulfide 0.5% ophthalmic ointment will move into phase 3 trials. This ointment is applied directly to the lower eyelid to open the meibomian gland (MGs), secretions from which prevent tear evaporation and tear overflow. Results last year from a phase 2 trial demonstrated improvement in MG secretions in treated patients. “It’s a very unique compound because it’s the only compound that could potentially open the meibomian gland orifices along lid margin and improve the quality of secretions,” Dr. Farid said.
• Reproxalap, a reactive aldehyde species (RASP) inhibitor, will be the subject of a new drug application (NDA) resubmission this year. RASPs have been found in elevated levels in ocular and systemic inflammatory disease. The FDA last year notified drug developer Aldeyra Therapeutics that an additional trial was needed to demonstrate efficacy in treating symptoms of DED. Aldeyra said it would resubmit the NDA and report topline trial results in the first half of the year. “That’s a really nice anti-inflammatory eye drop that works early in the inflammatory cascade,” Dr. Farid said. “It acts almost like a steroid does without having the side effects of the steroid.”
• AR-15512, a topical transient receptor potential melastatin 8 agonist, may also be the subject of an NDA this year. Topline results from two phase 3 trials last year demonstrated a clinically meaningful increase in tear production.

The Centers for Disease Control and Prevention estimates 3 million Americans have glaucoma. The use of daily eye drops to lower intraocular pressure (IOP) has been a mainstay of glaucoma therapy treatment for decades. However, a 2018 study put the rates of nonadherence as high at 67%.

In part to skirt the adherence issue, several approaches have evolved to lower IOP without relying on drops. They include laser treatments to perforate the eye’s trabecular meshwork and improve the outflow of aqueous humor, minimally invasive glaucoma surgery to create a small tunnel or even insert a shunt to enable aqueous outflow, and, more recently, implantable depots that release IOP-lowering drugs within the eye over months.

“Glaucoma is a disease that has a slow onset, so you have to diagnose it as early as possible,” Andrew Iwach, MD, a glaucoma specialist in San Francisco and clinical spokesperson for the American Academy of Ophthalmology, told this news organization. “One challenge with glaucoma is its chronic nature. There are different methods that are being looked at to achieve sustained release of drugs — ways you can implant a little bolus of this medicine,” Dr. Iwach added.

Glaucoma also requires regular monitoring of changes in IOP, Iwach noted. “During COVID, there was an increased interest in during this remotely,” he said. A remote monitoring platform, Peripherex, was registered last year with the FDA. It consists of a diagnostic online visual field test that can enable patients with glaucoma to provide data on disease changes from home.

A laser platform, the Belkin Eagle Nd:YAG laser for performing selective laser trabeculoplasty (SLT), in December 2023 received FDA clearance. Dr. Iwach said this is the first innovation in lasers in 20 years in that it eliminates the need for placing a diagnostic lens on the eye itself to direct the laser pulses, a technique called direct SLT. It uses a computer-driven tacking device.

Looking Ahead

A laser in development is ViaLase, which offers femtosecond laser image-guided high-precision trabeculotomy or FLigHT. The VIA-002 study, which began enrolling patients in September 2023, is comparing ViaLase with SLT to determine reduction in unmedicated IOP at 6 and 12 months. A small feasibility study published last year demonstrated safety of the procedure with an average reduction in IOP of 34.6% at 24 months.

Microshunts inserted into the eye also have been used to reduce IOP. An early stage study is evaluating a new-generation, minimally invasive shunt that, once implanted, allows the ophthalmologist to adjust the level of aqueous outflow in an office-based procedure.

Another December 2023 FDA approval was iDose TR, an implant loaded with the prostaglandin analog travoprost 75 mcg. The implant is scheduled for commercial release in the first quarter of 2024, with a projected wholesale acquisition cost of $13,950 per dose or implant.

Two phase 3 trials compared two iDose TR models with two different travoprost release intervals, defined as the fast- and slow-release iDose TR models, respectively, with topical timolol ophthalmic solution, 0.5% twice a day. The trials demonstrated comparable IOP reduction between all three vehicles. At 12 months, 81% of iDose TR subjects required no IOP-lowering topical medications across both trials.

Also in development is an implant that uses a cilioscleral technique to preserve the anterior chamber of the eye, reducing the risk for complications, such as endothelial cell loss or a filtration bleb, that can occur with other implant procedures. Preliminary results of a 12-month study of 57 patients fitted with a new design with the cilioscleral interpositioning device (CID) showed it lowered IOP an average of 13.9 mmHg vs 15.1 mmHg in earlier studies with the device. In the latest study, more than 85% of patients reported being medication free at 12 months. The CID procedure spares the conjunctiva, requiring only a local incision, according to its developers.

As for topical agents that reduce IOP, cannabinoids may soon find their way into the glaucoma specialist’s toolbox. A phase 2 trial evaluating SBI-100 ophthalmic emulsion started enrolling patients late last year. SBI-100 OE is a synthetic prodrug of tetrahydrocannabinol that can bind and activate cannabinoid receptor type 1 in ocular tissues. The trial is scheduled for completion later this year. A phase 1 trial last year demonstrated an average reduction in IOP of 24%.

Another area of focus is on the use of preservatives in topical drops. “One of big issues we’re dealing with is preservatives because you’re marinating these eyes over years with these drops,” Dr. Iwach said. Late last year, the first preservative-free form of latanoprost ophthalmic solution 0.005% launched in the United States. Other delivery systems that remove preservatives from topical drops and preservative-free formulations are in the investigative stage, he said.

Dr. Farid disclosed financial relationships with Alcon Laboratories, Allergan/AbbVie, Bausch + Lomb, Bio-Tissue, CorneaGen, Harrow, Kala Pharmaceuticals, and Tarsus Pharmaceuticals. Dr. Iwach disclosed a previous financial relationship with Belkin Vision as well as relationships with Alcon Laboratories and Innovia.

A version of this article appeared on Medscape.com.

Dry eye and glaucoma may be the two most confounding conditions ophthalmologists face. Late last year, the US Food and Drug Administration (FDA) approved three new treatments for dry eye disease (DED) and one new procedure for glaucoma, which means ophthalmologists will soon have the opportunity to incorporate these therapies into their practices. Meanwhile, several investigative treatments for both chronic ailments will continue to move forward.

Undry Those Eyes

Based on a 2022 study in JAMA Ophthalmology, about 27 million Americans have some form of DED or meibomian gland dysfunction. Treatments aim to preserve and enhance tears and tear production to counteract the grittiness and itchiness that accompany DED.

“For decades, we only had one treatment [cyclosporine] for dry eye, then the second one a few years ago, which is lifitegrast, but nothing innovative until very recently,” Marjan Farid, MD, director of cornea, cataract and refractive surgery at the Gavin Herbert Eye Institute at the University of California-Irvine, told this news organization.

“In 2023, I feel that innovation from the pharmaceutical standpoint in this space really exploded, and it’s very exciting because dry eye disease is such a multifactorial disease that you can’t just go after one angle,” said Dr. Farid, who is also chair of the American Society of Cataract and Refractive Surgery’s cornea clinical committee. “You really need to be able to attack dry eye disease from multiple areas, when the meibomian glands are involved, or whether or not there’s blephartitis.”

The three treatments for DED the FDA approved last year are lotilaner 0.25% ophthalmic solution, which targets the Demodex mites that cause of Demodex blepharitis, a trigger for DED; perfluorohexyloctane ophthalmic solution; and cyclosporine ophthalmic solution 0.1%. The latter two agents coat the ocular surface — perfluorohexyloctane acting as a shield to prevent tear evaporation and cyclosporine 0.1% using perfluorobutylpentane to allow the immunosuppressant cyclosporine to penetrate deeper into the eye.

This year, Dr. Farid said, while ophthalmologists will be adopting those treatments, they’ll also be watching three emerging treatments poised to report results from clinical trial or take other steps toward FDA approval. They include:

• Selenium sulfide 0.5% ophthalmic ointment will move into phase 3 trials. This ointment is applied directly to the lower eyelid to open the meibomian gland (MGs), secretions from which prevent tear evaporation and tear overflow. Results last year from a phase 2 trial demonstrated improvement in MG secretions in treated patients. “It’s a very unique compound because it’s the only compound that could potentially open the meibomian gland orifices along lid margin and improve the quality of secretions,” Dr. Farid said.
• Reproxalap, a reactive aldehyde species (RASP) inhibitor, will be the subject of a new drug application (NDA) resubmission this year. RASPs have been found in elevated levels in ocular and systemic inflammatory disease. The FDA last year notified drug developer Aldeyra Therapeutics that an additional trial was needed to demonstrate efficacy in treating symptoms of DED. Aldeyra said it would resubmit the NDA and report topline trial results in the first half of the year. “That’s a really nice anti-inflammatory eye drop that works early in the inflammatory cascade,” Dr. Farid said. “It acts almost like a steroid does without having the side effects of the steroid.”
• AR-15512, a topical transient receptor potential melastatin 8 agonist, may also be the subject of an NDA this year. Topline results from two phase 3 trials last year demonstrated a clinically meaningful increase in tear production.

The Centers for Disease Control and Prevention estimates 3 million Americans have glaucoma. The use of daily eye drops to lower intraocular pressure (IOP) has been a mainstay of glaucoma therapy treatment for decades. However, a 2018 study put the rates of nonadherence as high at 67%.

In part to skirt the adherence issue, several approaches have evolved to lower IOP without relying on drops. They include laser treatments to perforate the eye’s trabecular meshwork and improve the outflow of aqueous humor, minimally invasive glaucoma surgery to create a small tunnel or even insert a shunt to enable aqueous outflow, and, more recently, implantable depots that release IOP-lowering drugs within the eye over months.

“Glaucoma is a disease that has a slow onset, so you have to diagnose it as early as possible,” Andrew Iwach, MD, a glaucoma specialist in San Francisco and clinical spokesperson for the American Academy of Ophthalmology, told this news organization. “One challenge with glaucoma is its chronic nature. There are different methods that are being looked at to achieve sustained release of drugs — ways you can implant a little bolus of this medicine,” Dr. Iwach added.

Glaucoma also requires regular monitoring of changes in IOP, Iwach noted. “During COVID, there was an increased interest in during this remotely,” he said. A remote monitoring platform, Peripherex, was registered last year with the FDA. It consists of a diagnostic online visual field test that can enable patients with glaucoma to provide data on disease changes from home.

A laser platform, the Belkin Eagle Nd:YAG laser for performing selective laser trabeculoplasty (SLT), in December 2023 received FDA clearance. Dr. Iwach said this is the first innovation in lasers in 20 years in that it eliminates the need for placing a diagnostic lens on the eye itself to direct the laser pulses, a technique called direct SLT. It uses a computer-driven tacking device.

Looking Ahead

A laser in development is ViaLase, which offers femtosecond laser image-guided high-precision trabeculotomy or FLigHT. The VIA-002 study, which began enrolling patients in September 2023, is comparing ViaLase with SLT to determine reduction in unmedicated IOP at 6 and 12 months. A small feasibility study published last year demonstrated safety of the procedure with an average reduction in IOP of 34.6% at 24 months.

Microshunts inserted into the eye also have been used to reduce IOP. An early stage study is evaluating a new-generation, minimally invasive shunt that, once implanted, allows the ophthalmologist to adjust the level of aqueous outflow in an office-based procedure.

Another December 2023 FDA approval was iDose TR, an implant loaded with the prostaglandin analog travoprost 75 mcg. The implant is scheduled for commercial release in the first quarter of 2024, with a projected wholesale acquisition cost of $13,950 per dose or implant.

Two phase 3 trials compared two iDose TR models with two different travoprost release intervals, defined as the fast- and slow-release iDose TR models, respectively, with topical timolol ophthalmic solution, 0.5% twice a day. The trials demonstrated comparable IOP reduction between all three vehicles. At 12 months, 81% of iDose TR subjects required no IOP-lowering topical medications across both trials.

Also in development is an implant that uses a cilioscleral technique to preserve the anterior chamber of the eye, reducing the risk for complications, such as endothelial cell loss or a filtration bleb, that can occur with other implant procedures. Preliminary results of a 12-month study of 57 patients fitted with a new design with the cilioscleral interpositioning device (CID) showed it lowered IOP an average of 13.9 mmHg vs 15.1 mmHg in earlier studies with the device. In the latest study, more than 85% of patients reported being medication free at 12 months. The CID procedure spares the conjunctiva, requiring only a local incision, according to its developers.

As for topical agents that reduce IOP, cannabinoids may soon find their way into the glaucoma specialist’s toolbox. A phase 2 trial evaluating SBI-100 ophthalmic emulsion started enrolling patients late last year. SBI-100 OE is a synthetic prodrug of tetrahydrocannabinol that can bind and activate cannabinoid receptor type 1 in ocular tissues. The trial is scheduled for completion later this year. A phase 1 trial last year demonstrated an average reduction in IOP of 24%.

Another area of focus is on the use of preservatives in topical drops. “One of big issues we’re dealing with is preservatives because you’re marinating these eyes over years with these drops,” Dr. Iwach said. Late last year, the first preservative-free form of latanoprost ophthalmic solution 0.005% launched in the United States. Other delivery systems that remove preservatives from topical drops and preservative-free formulations are in the investigative stage, he said.

Dr. Farid disclosed financial relationships with Alcon Laboratories, Allergan/AbbVie, Bausch + Lomb, Bio-Tissue, CorneaGen, Harrow, Kala Pharmaceuticals, and Tarsus Pharmaceuticals. Dr. Iwach disclosed a previous financial relationship with Belkin Vision as well as relationships with Alcon Laboratories and Innovia.

A version of this article appeared on Medscape.com.