IND approval allows Phase 2/3 pivotal trial for Stargardt gene therapy to move forward

Ocugen announced that it received approval of its Investigational New Drug amendment for OCU410ST, allowing the company to begin a Phase 2/3 pivotal confirmatory trial of the modifier gene therapy candidate in development for Stargardt disease (ABCA4-associatiated retinopathies). The company stated in a press release that clinical development of this gene therapy is being expedited by 2–3 years. The Phase 2/3 trial will enroll 51 participants with Stargardt disease; 34 will receive a single subretinal injection of OCU410ST in the eye with poorer visual acuity, and 17 will serve as an untreated control. The primary endpoint is reduction in atrophic lesion size; secondary endpoints include improvement in BCVA and low luminance visual acuity. Ocugen’s press release reiterated positive data from its Phase 1 trial that demonstrated a favorable safety and tolerability profile, slower lesion growth rate in treated eyes, and a clinically meaningful gain in BCVA at 12 months of follow-up (nearly 2 lines) in treated eyes.

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FDA approves generic anti-inflammatory

The FDA has approved Amneal Pharmaceutical’s prednisolone acetate ophthalmic suspension, 1%, as a generic anti-inflammatory that references the brand-name Pred Forte (AbbVie), for treatment of steroid-responsive ocular inflammation. The product’s launch is planned for the third quarter of this year.

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NDA resubmitted for dry eye disease drug candidate

Aldeyra Therapeutics announced its resubmission of a New Drug Application for reproxalap, an investigational new drug candidate for the treatment of signs and symptoms of dry eye disease. According to the company’s press release, it included new clinical data in the resubmitted NDA from a recently completed dry eye chamber trial. This trial, the company reported, achieved its primary endpoint. In its April 2025 Complete Response Letter, the FDA cited “potential methodological issues in a previously completed dry eye chamber trial … [that] may have affected the interpretation of the results.” Results from a Phase 3 trial were announced in May 2025; among these were a reduction in ocular discomfort, no notable differences in baseline scores across treatment arms, and no safety concerns.

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Review article finds high acceptance of AI in ophthalmology

A literature review published in the journal Eye evaluated the awareness, acceptance, and concerns about artificial intelligence in the ophthalmic community. Insights in these areas, the authors wrote, is “essential to ensure its successful implementation.” The literature review included 16 studies. Most of the studies, they wrote, “only emphasized performance expectancy and effort expectancy.” Discussions about the “social influence, facilitating conditions, and relevant regulating factors were relatively inadequate” overall, according to the authors. However, the acceptance of AI within ophthalmology (among patients with eye diseases, experts in ophthalmology, professionals in other fields, and the general population) was high. The authors advocated for “more well-designed qualitative studies with clear definitions of acceptance and using proper psychological models with larger sample sizes involving other representative and multidisciplinary stakeholders.” To address concerns regarding AI and to promote overall acceptance, the authors stated that clinician training is needed, as well as technologies to preserve privacy and to account for cost effectiveness.

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ASCRS news and events

• Business of Refractive Cataract Surgery Summit: This course, taking place October 3–5, in Chicago, Illinois, along with its extensive, take-home resource library, will help practices gain the navigational tools needed to increase premium IOL adoption and lead patients effectively on their refractive surgery journey. Learn more.
• ASCRS Live!: This educational dinner series is heading to several cities across the U.S. in 2025. Registration is open for the next event in Seattle, Washington, on July 24.
• ASCRS Grand Rounds: A new episode of ASCRS Grand Rounds, featuring cases involving a challenging intraoperative cataract surgery complication and a referral for a corneal mass, is online now. Watch the episode, which is eligible for CME, here.
• 2026 ASCRS Annual Meeting: Hotel room blocks are now open for the 2026 ASCRS Annual Meeting, taking place in Washington, D.C., April 10–13, 2026.

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Research highlights

• A systematic review and metanalysis published in JAMA Ophthalmology evaluated the association of CTR implantation on IOL position. The authors included randomized clinical trials or prospective cohort studies that reported the effect or association of CTR on postop anterior chamber depth, IOL decentration, tilt, and rotation, published from the time CTRs were invented until October 2024. The analysis identified 11 randomized controlled trials and 7 cohort studies (809 eyes with CTRs and 822 without). IOL tilt and rotation amounts were less in the group that received a CTR compared to those without, according to the investigators. Additional subgroup analyses were also conducted. The authors concluded that CTRs were associated with enhanced IOL stability when it came to rotation but only reduced IOL tilt in the setting of high myopia. “While the direct clinical relevance of these results could not be determined from this investigation, these findings provide evidence supporting use of CTR implantation when toric IOLs have been implanted or with high myopia, although a hyperopic refractive shift after implantation of plate haptic IOLs may require target refraction adjustment,” they wrote.
• In a theoretical study, a theoretical method to predict the ratio between changes in IOL power and induced variations in ocular refraction was developed. The investigators computed the theoretical changes in IOL power for desired variations in ocular refraction using a paraxial pseudophakic eye model. That formulation was then validated against the Haigis formula. The authors evaluated many eye models with different axial lengths, keratometry readings, and effective implant positions. Keratometry and effective lens position on IOL power-refraction change ratio was also studied. They found keratometric power and ELP had a significant impact on “determining theoretical magnitude of IOL power increment required for a specific dioptric change in refraction.” The model created, the authors wrote, provides “theoretical trends for guiding clinicians in predicting the necessary IOL power adjustments for desired refractive changes in pseudophakic eyes.” “This work also suggests potential applications in the fine tuning of adjustable IOLs and more customized IOL power selection for a range of refractive surgeries,” they concluded. The research is published in the Journal of Cataract & Refractive Surgery.

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Product news

• Johnson & Johnson Vision launched its TECNIS Odyssey IOL in Europe, the Middle East, and Canada.

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