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The 0.1 mg/ml atropine eye drop for paediatric myopia is licensed from Sydnexis, Inc.

European Commission approves low-dose atropine eye drop Ryjunea, Santen announces

An official approval by the FDA in the United States can boost adoption rate of atropine and antimyopia glasses, which will change the landscape of myopia management.

Atropine vs spectacles: Which move will be more powerful in the game of myopia management?

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Mitch Ibach, OD, FAAO, details a presentation he gave with Tanner Ferguson, MD, at the Collaborative Care Symposium 2025.

CCS 2025: Tackling the complexities of glaucoma management

Both preservative-free, contact lens-friendly drops will be available in most national retailers.

Bausch + Lomb launch Blink Nourish Lubricating eye drops and Blink Boost Lubricating eye drops in the US for dry eye

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Eyecare practitioners' top misconceptions just may surprise you.

Debunking common ortho-k myths

Boehringer Ingelheim announced the start of the JADE and VERDANT phase 2 clinical studies to investigate the safety and efficacy of 2 candidates: BI 1584862, a potential first-in-class oral compound for the treatment of geographic atrophy (GA), an advanced form of age-related macular degeneration (AMD)

; and BI 771716, an antibody fragment, respectively. BI 1584862 is a phospholipid modulator intended to preserve patient vision by targeting inflammation and preserving vascular function. It follows Boehringer Ingelheim’s other candidate under investigation for the treatment of GA, BI 771716, in kicking off phase 2 investigation.

 Both announcements coincided with the Association for Research in Vision and Ophthalmology (ARVO) 2025 Annual Meeting, which took place May 4 through May 8, 2025, in Salt Lake City, Utah.

“Vision loss associated with geographic atrophy profoundly affects the lives of those impacted, particularly older adults, making daily activities more difficult. The loss of independence has a significant burden for patients, caregivers and society overall. I’m excited to see that Boehringer Ingelheim is exploring treatment options aimed at reducing the treatment and visit burden for patients and their caregivers,” Karl Csaky, MD, PhD, principal investigator of the phase 2 trial and CEO and chief medical officer of the Retina Foundation of the Southwest, said in a press release. “An oral treatment could alleviate the burden of existing treatment regimens and offer the opportunity to address both eyes simultaneously in patients with [bilateral] disease.”

BI 771716, also under phase 2 investigation, is a highly specific antibody fragment that targets GA pathology through optimized penetration of the retinal layers. Boehringer says its molecular properties have to potential to achieve unprecedented efficacy.

Currently, only 2 therapeutics are FDA approved to slow the progression of GA: pegcetacoplan (Syfovre; Apellis Pharmaceuticals) and avacincaptad pegol (Izervay; Astellas Pharma). A photobiomodulation device (Valeda; LumiThera) is FDA-approved to improve visual outcomes in patients with dry AMD. Boehringer Ingelheim’s hopeful therapeutics would widen the treatment landscape further, giving eye care providers the chance to choose the treatment that is best for the patient and their lifestyle.

“At Boehringer Ingelheim, we recognize the need for treatments that address the diverse needs of GA patients and of the medical community. Our commitment is reflected in our Phase II clinical trials investigating 2 distinct compounds, BI 1584862 and BI 771716, each targeting different pathways. This approach highlights our dedication to providing tailored solutions that support the individual needs of people living with the condition,” Patrick Bussfeld, MD, PhD, global head of medicine, eye health, at Boehringer Ingelheim, said in a press release. “By exploring multiple avenues, we are seeking to offer more individualized treatment options and, ultimately, improve the quality of life for people living with geographic atrophy."

In April 2023, Boehringer announced it was partnering with RetinAI to leverage its artificial intelligence (AI) properties in pursuit of pipeline advancement. The plan was to use RetinAI’s Discovery platform and range of AI tools to scour imaging to detect novel biomarkers and markers of disease progression as Boehringer continued research on its GA candidates.

At ARVO 2025, Boehringer presented 19 abstracts across its eye health portfolio, which aims to address unmet need for retinal conditions.

1. Boehringer Ingelheim starts Phase II study of its potential first-in-class oral compound as a treatment for geographic atrophy​. Boehringer Ingelheim. Press release. Published May 6, 2025. Accessed May 7, 2025. 

https://www.boehringer-ingelheim.com/science-innovation/human-health-innovation/phase-ii-start-oral-treatment-geographic-atrophy

2. A study to test different doses of BI 1584862 in people with a distinct form of age-related macular degeneration (AMD) called geographic atrophy. ClinicalTrials.Gov. Accessed May 7, 2025. 

https://clinicaltrials.gov/study/NCT06769048?cond=BI%201584862&rank=5

3. A study to test whether BI 771716 helps people with an advanced form of age-related macular degeneration (AMD) called geographic atrophy (VERDANT). ClinicalTrials.Gov. Accessed May 7, 2025. 

https://clinicaltrials.gov/study/NCT06722157?cond=BI%20771716&rank=1

4. Hutton D. RetinAI, Boehringer Ingelheim team up with shared vision to use AI to develop treatments for patients with geographic atrophy. 

https://www.ophthalmologytimes.com/view/retinai-boehringer-ingelheim-team-up-with-shared-vision-to-use-ai-to-develop-treatments-for-patients-with-geographic-atrophy

Boehringer Ingelheim announced that the phase 2 clinical studies will investigate a potential first-in-class oral compound and a highly specific antibody fragment for geographic atrophy.

Pipeline

Boehringer Ingelheim kicks off dual phase 2 clinical studies for geographic atrophy candidates

In light of the recent US Court of International Trade (CIT) decision to permanently prohibit all tariffs imposed by President Donald J. Trump under the International Emergency Economic Powers Act (IEEPA), The Vision Council weighed in to assess what the decision means for the vision industry.

With the decision made on May 28, the CIT has given the federal government 10 days to implement a process to halt the collection of IEEPA-related duties, according to a news release. This includes the 25% tariff on goods from Mexico and Canada, the 20% tariff on goods from China, and reciprocal tariffs set at 10% that are scheduled to increase to higher, country-specific rates in July of this year.

In response to the ruling and an appeal submitted by the Trump administration, the US Court of Appeals for the Federal Circuit issued a temporary stay on May 29, which allows the continued collection of the tariffs as the government moves through the appeal process.

“Fluctuating trade policies create real uncertainty for businesses across the vision industry, and we understand how challenging that can be,” said Ashley Mills, CEO of The Vision Council, in the release. “We remain committed to keeping our members informed, supported, and prepared to adapt. Our team is actively monitoring the ongoing legal developments, and we will continue to provide timely updates and resources. We encourage members to reach out to our Government Relations and Regulatory Affairs teams for guidance on how this ruling may affect their operations and supply chains.”

The CIT ruling, therefore, prohibits further collection of the tariffs unless a stay is granted. Although the decision does not mandate funds for duties previously paid, a means for refunds may be possible once the decision is final.

In response to the CIT decision, the Trump administration had filed a notice of appeal with the US Court of Appeals for the Federal Circuit and is expected to seek a stay of execution. The appeal has the potential to see the US Supreme Court during the appeal process.

Currently, all previously established duties remain in effect for the next 10 days as of May 28. An additional note from The Vision Council is that the decision does not impact Section 301 on Chinese goods, which are currently enforced under a separate statutory authority and are currently involved in a separate legal appeal. The CIT decision also does not impact the Section 232 duties on steel or aluminum, or automobiles and their parts.

Since there is no immediate change to the collection of IEEPA duties, The Vision Council’s Tariff Dashboard will not reflect changes for the tariffs until there are further updates.

US Court of International Trade strikes down IEEPA tariffs: What this means for the vision industry. News release. The Vision Council. May 29, 2025. Accessed May 30, 2025.

Federal appeals court temporarily reinstates IEEPA tariffs amid ongoing legal proceedings. News release. The Vision Council. May 30, 2025. Accessed May 30, 2025.

A recent US Court of International Trade decision was made on May 28 to permanently prohibit all tariffs imposed by President Donald J. Trump under the International Emergency Economic Powers Act.

Recent tariff decisions, appeals have no immediate effect on vision industry, The Vision Council reports

An investigation into incomplete retinal pigment epithelial and outer retinal atrophy (iRORA) identified a wide spectrum of fundus autofluorescence (FAF) patterns that corresponded with iRORA lesions and that those patterns were associated with conversion to complete RORA (cRORA) over time. First author Giulia Corradetti, MD, reported the study findings at the Association for Research in Vision and Ophthalmology 2025 annual meeting in Salt Lake City, Utah. She is from the Doheny Eye Institute, Pasadena, California, and the Department of Ophthalmology, David Geffen School of Medicine at the University of California Los Angeles.

The research team explained that “while the criteria for iRORA are well-defined, the iRORA phenotype on optical coherence tomography (OCT) B-scans can vary based on the extension of the lesions, hypertransmission into the choroid, disruption of the retinal pigment epithelium (RPE), and the number of signs of photoreceptor degeneration present.”

In light of that, the group set out to define the FAF phenotypes of iRORA lesions and the baseline FAF patterns associated with conversion of iRORA to cRORA within 18 months. iRORA has been characterized on OCT by hypertransmission into the choroid and RPE attenuation or disruption by less than 250 microns and by signs of photoreceptor degradation, ie, at least one of the following: ellipsoidal zone (EZ) attenuation/disruption, external limiting membrane (ELM) attenuation/disruption, outer nuclear layer (ONL) thinning, outer plexiform layer (OPL)/inner nuclear layer (INL) subsidence, and hyporeflective wedges in the Henle fiber layer.

In contrast, cRORA is characterized by hypertransmission into the choroid and RPE attenuation or disruption by more than 250 microns and by signs of photoreceptor degradation, ie, EZ and interdigitization zone discontinuity, ELM attenuation/disruption, ONL thinning, and OPL/INL subsidence.

In this study, Corradetti and colleagues pooled data for a post hoc analysis from 448 patients who participated in the phase 3 GATHER2 trial (NCT04435366) that evaluated the efficacy and safety of avacincaptad pegol 2 mg (Izervay; Astellas Pharma) in patients with geographic atrophy (GA) that did not involve the foveal center.

 The patients were evaluated for the presence of baseline iRORA and completed 3 follow-up visits at 6, 12, and 18 months.

The investigators evaluated each iRORA lesion at baseline and during follow-up to identify any changes in FAF phenotypes. The patterns were defined as “none,” indicating no autofluorescence abnormalities; not classifiable; increased autofluorescence (IAF); questionably decreased autofluorescence (QDAF); or definite decreased autofluorescence (DDAF).

The results identified 153 iRORA lesions in 95 eyes. Most were classified as none (53 lesions; 34.6%) or as QDAF (53 lesions, 34.6%). The remainder were not classifiable (27 lesions, 17.6%), DDAF (11 lesions, 7.2%) and IAF (9 lesions, 5.9%), Corradetti and colleagues reported.

After 18 months, OCT showed that the number of iRORA lesions decreased to 51.0%, and the number of new cRORA lesions increased and peaked at 15.0% by 12 months.

At the same time point, the FAF phenotypes were seen to have changed over time. The proportion of total iRORA lesions manifesting QDAF and DDAF patterns increased to 38.1% and 23.0%, respectively, whereas the “none” pattern decreased to 16.8%.

At 18 months, the majority of lesions that remained as persistent iRORA were classified as having the none (28/78) or QDAF FAF pattern. The none classification decreased from 90.6% of lesions at 6 months to 52.8% at 18 months, and the QDAF pattern from 79.2% to 49.1% at the respective time points.

At 18 months, the iRORA lesions that converted to cRORA were more likely to have more advanced FAF abnormalities, with cumulative 44.4% IAF, 30.2% QDAF, and 27.3% DDAF patterns, the investigators reported.

“This first large study characterizing the phenotype of iRORA on FAF highlights the heterogeneity of these lesions. Multimodal imaging, including both OCT and FAF, may allow a more granular classification of iRORA. A wide spectrum of FAF patterns corresponded with iRORA lesions identified on OCT at baseline and was associated with conversion of iRORA to cRORA over time. These findings underline a novel opportunity to potentially categorize those patterns from early to late lesion phenotypes using FAF. Early identification of atrophic changes may help doctors make informed treatment decisions to slow disease progression, help preserve photoreceptors, and help preserve vision,” Corradetti and colleagues concluded.

Khanani AM, Patel SS, Staurenghi G, et al. Efficacy and safety of avacincaptad pegol in patients with geographic atrophy (GATHER2): 12-month results from a randomised, double-masked, phase 3 trial. 

The results of an investigation into iRORA identified a wide spectrum of fundus autofluorescence patterns that corresponded with iRORA lesions and that those patterns were associated with conversion to cRORA over time. 

iRORA phenotypes characterized using fundus autofluorescence

A recent study has found an underrepresentation of uveitis in clinical trials conducted in the past 2 decades. In assessing the institutional, geographic, and temporal disparities in US uveitis clinical trials from 2000 to 2023, study authors noted that the disparities in trial access that were demonstrated can exacerbate inequities affecting underserved communities.

The study authors were led by Jainam Shah of Albert Einstein College of Medicine in the Bronx, New York.

Researchers identified phase 2-4 uveitis trials during the time period from clinicaltrials.gov, with trials without US sites or multicenter trials lacking site-level data excluded from the study. Categories for the trials consisted of sponsorship (public, private, and unknown), institution (academic, public, private, unknown), geography (south, west, midwest, northeast), and anatomy (anterior, intermediate, posterior, uveitic macular edema, or unspecified/general uveitis). Statistical significance was set at 

 < .05, and adjusted odds ratios (aORs) with 95% confidence intervals (CIs) were calculated, with sponsorship and institution categories analyzed separately and enrollment sizes compared between institutions. Private sponsorship ultimately accounted for over 55% of trials, followed by public (27.6%) and unknown (17.3%), with posterior uveitis most studied at almost 42%.

Results from the research that included 98 trials found that private trials increased from 28.8% (2000–2011) to 58.6% (2012–2023), while public trials declined from 40.9% to 22.4% (

 = .006). Additionally, uveitis trials rose from 22.7% to 51.7% (

 = .002). On average, private trials enrolling more participants (median: 92, interquartile range 65–110) than public (54; 40–74), academic (36; 26–50), and unknown trials (40; 32–68) (

 = .004). Notably, trials from 2012 through 2023 were more likely to be privately sponsored (2.84; 1.05–7.68; 

“Although these trials offer broader enrollment, their concentration in the South/West and private sponsorship limit access for patients in the Midwest, Northeast, and public systems. Academic studies on neglected subtypes like intermediate uveitis or macular edema remain underrepresented,” the study authors stated.

Additionally, a surge in posterior uveitis studies was observed in 2016 following the US Food and Drug Administration’s approval of adalimumab.

“These findings align with concerns that uveitis care and by extension, access to trials remains concentrated in resource-rich centers, with geographic barriers disproportionately affecting underserved populations,” the study authors stated, noting that 36.7% of Americans live more than an hour from a uveitis specialist, with these populations having higher rates of poverty and public insurance. “Moreover, fewer than 200 uveitis specialists are active nationally, often lacking support staff or institutional infrastructure to run trials. Public investment and academic incentives are necessary to address these inequities and promote equitable innovation in ophthalmology.”

Shah J, Pathuri S, Wilkins CS, et al. Unequal access and evolving priorities in US uveitis clinical trials: A 23-year analysis of regional, institutional, and anatomic trends. 

https://doi.org/10.1038/s41433-025-03854-7

Researchers included 98 phase 2-4 uveitis trials during the time period from clinicaltrials.gov.

Disparities found in uveitis clinical trials access by researchers

Let My Doctors Decide Action Network’s (LMDD AN) new national scorecard has exposed disparities in insurance coverage for serious and rare eye diseases.

 The LMDD Eye Health Scorecard specifically evaluated insurance coverage for treatments addressing geographic atrophy (GA), neovascular age-related macular degeneration (AMD), and thyroid eye disease, according to a news release.

The scorecard thus highlighted the fact that millions of American patients face barriers to accessing life-changing treatments based on their health plan.

“Despite medical advancements, many patients are still trapped in a system where access depends on the luck of their insurance card,” said Brett McReynolds, policy adviser for LMDD AN, in the release. “We urge policymakers, insurers, and health care leaders to break down these harmful, unnecessary barriers and prioritize patient health over administrative red tape.”

Some of the findings from the scorecard include Medicaid plans having the greatest restrictions and Medicare plans having the fewest access restrictions overall. Approximately 70% of state Medicaid plans received an “F” grade across all conditions assessed. Access for patients with Managed Medicaid plans was slightly better, even though a majority of plans received a “C” or “F” score for their coverage of all conditions included. Additionally, traditional Medicare received an “A” grade for nearly 100% of its plans for all conditions where treatments were administered under the medical benefit. Even with more restrictions imposed in the Medicare Advantage plans, a majority of said plans received either “A” or “B” grades for all conditions.

Other findings from the scorecard revealed a significant variation in coverage and access by disease condition and plan type, and about half of Commercial, Health Exchange, and Medicaid plans received either “C” or “D” grades. On average, beneficiaries of Commercial, Health Exchange, and Medicaid plans experience at least 2 access restrictions on average.

The scorecard underscored that most patients experience restrictive insurance policies, including authorization, onerous step therapy, and high cost-sharing, which can delay or limit access to prescribed treatments.

“For patients battling serious and rare eye conditions, timely access to treatment isn’t a luxury—it’s a lifeline to prevent permanent and irreversible vision loss,” said Molly Murray, president and CEO of the Autoimmune Association, in the release. “The results expose a health care system that is failing to meet its most fundamental promise: providing care when and where it’s needed.”

The scorecard was compiled by analyzing thousands of private, Medicare, and Medicaid health plans across the US and was developed in partnership with health care research firm MMIT, which provided data for the scorecard. The evaluation focused on US Food and Drug Administration-approved treatments for the 4 conditions and assessed coverage under both medical benefit and pharmacy benefit, or drugs administered in a doctor’s office and medications dispensed through a pharmacy. Plans were given a numeric score of 0 to 4, with higher scores reflecting larger barriers to access based on the presence of step therapy, prior authorization, and/or placement on a plan’s specialty tier. Those numerical scores were then converted into letter grades.

“Without adequate and timely insurance coverage, patients living with debilitating, rare eye diseases face devastating, life-altering consequences—not just loss of vision, but also loss of independence, employment, and quality of life,” said Jeff Todd, president and CEO of Prevent Blindness, in the release. “The LMDD Eye Health Scorecard findings underscore the urgent need for policy and regulatory reforms to ensure equitable access to sight-saving treatments, with limited barriers between diagnosis and treatment delivery.”

New eye health scorecard reveals gaps in treatment across insurance plans. News release. Let My Doctors Decide Action Network. May 22, 2025. Accessed May 22, 2025.

The LMDD Eye Health Scorecard specifically evaluated insurance coverage for treatments addressing GA, neovascular AMD, and thyroid eye disease.

New national scorecard exposes insurance coverage disparities for vision-threatening disease treatments

At this year’s ARVO annual meeting, 2 posters presenting data initiated by SightGlass highlighted the growing body of clinical evidence supporting the use of 

. Debbie Laughton, BSc, PhD, provided expert commentary on 2 significant studies: CYPRESS, a 4-year, multicenter clinical trial in North America, and a complementary study conducted across 5 sites in China. Together, these studies not only reaffirm the safety and efficacy of DOT lenses in slowing myopia progression but also address key concerns such as rebound effects post treatment and effectiveness across diverse populations.

In the following Q&A, Laughton discusses the methodologies, clinical relevance, and broader implications of these studies, offering valuable guidance for optometrists already managing pediatric myopia, as well as those considering expanding their scope of care in response to rising global prevalence.

For those who weren’t able to attend ARVO this year, can you detail the parameters and methods of the research featured in this poster?

Poster #1: CYPRESS, our pivotal 4-year multicenter clinical trial, demonstrated DOT lenses are safe and effective at slowing the progression of myopia in a population of North American children. Children enrolled in CYPRESS were invited to join a follow-up study, BIRCH, to evaluate whether there is an acceleration of myopia progression or ‘rebound effect’ following the cessation of DOT lens treatment. Twelve months after ceasing treatment, refraction and axial length reverted to age-normative rates, indicating no significant rebound effect.

Poster #2: To evaluate the safety and efficacy of DOT spectacle lenses in a Chinese population, where the prevalence and severity of myopia is even greater, a new study was initiated at 5 sites in China. The first 12-month results were presented at ARVO and demonstrated excellent safety and efficacy of DOT lenses, slowing myopia progression by 75%.

How did the actual performance of the DOT lenses compare to your expectations?

DOT lenses performed as expected, significantly slowing myopia progression and demonstrating no evidence of rebound effect once treatment was stopped.

This study took place in China. What does this mean for eye care providers in the US? How does this build upon Cypress?

The first-year results from our study in China support the outcomes from the North American (CYPRESS) clinical trial. Eye care providers can feel confident that DOT lenses effectively slow myopia progression in children from diverse racial and ethnic backgrounds, demonstrating consistent results across both Asian and North American populations.

What are the next steps in this research?

We have presented the interim results from our study in China, and we will be continuing this study for another 2 years to evaluate longer-term efficacy among Chinese children.

What immediately applicable clinical advice does this research yield, especially for optometrists who practice myopia management? What about doctors who see pediatric patients but

Based on these results, eye care professionals can feel confident in the performance and lasting impact of DOT lenses to slow myopia progression in their pediatric patients.

What was the response to these findings at the meeting? How do you think this research fits into the broader landscape of clinical research presented at ARVO, especially this session?

Myopia continues to be a hot topic in optometry, and the myopia poster sessions were incredibly busy. There was a lot of interest in the performance of DOT lenses and a clear demand from eye care professionals from the US to have access to spectacle lens myopia management technologies (DOT lenses are for investigational use only in the US). The theme of contrast reduction for myopia control was discussed during several other paper and poster sessions, showing the growing interest in contrast management. An education session led by Professor James Wolffsohn also explored the suggestion that all defocus-based optical interventions may operate via contrast management.

New data from North American and Chinese clinical trials reinforce the safety, efficacy, and durability of DOT lenses in slowing pediatric myopia progression, without evidence of rebound. 

Chandra Mickles, OD, MS, FAAO, FSLS

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