Meeting with FDA to advance therapy for Leber congenital amaurosis

Opus Genetics announced its completion of a Type B Regenerative Medicine Advanced Therapy meeting with the FDA for OPGx-LCA5 as a gene therapy for Leber congenital amaurosis caused by LCA5 gene mutations. The meeting will influence the company’s registration strategy and pivotal trial design. According to the company’s press release, it is already evaluating and enrolling patients in its Phase 3 trial. Dosing is expected to begin the second half of 2026, with topline results the following year.

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36-month data from first-in-human bimatoprost-IOL system

SpyGlass Pharma announced 36-month data from the first-in-human trial for its Bimatoprost Drug Pad-IOL System for patients with mild-to-moderate open angle glaucoma. According to the company’s press release, patients achieved a 37% mean reduction in IOP across the dose groups, with 95% of them remaining off topical IOP-lowering drops. From a BCVA standpoint, 100% of patients who were available for evaluation achieved 20/30 or better vision, and there were no product-related adverse events. Three-month data from a separate Phase 1/2 trial reported details at different dose levels. There was a 37% and 36% mean IOP reduction with the 78 mcg and 39 mcg dose groups, respectively. Ninety-eight percent and 96% of patients were off IOP-lowering drops in the 78 mcg and 39 mcg dose groups, respectively. The company reported that safety results were comparable to that of routine cataract surgery. Long-term follow-up will continue with both trials as the company plans to advance toward Phase 3 clinical trials.

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20-week data from study evaluating treatment for patients with macular edema secondary to inflammation

Kodiac Sciences announced data showing meaningful vision gains as early as week 4 and continuing through week 20 with KSI-101 as a treatment for macular edema secondary to inflammation. According to the company’s press release, more than half of patients achieved a 3 line or greater improvement, and more than 90% of patients in the top two dose levels achieved sustained dryness of the retina (absence of intraretinal fluid and subretinal fluid). KSI-101 is an antibody-based investigational therapy targeting interleukin-6 and VEGF. Phase 3 trials investigating the 5 mg and 10 mg doses in patients with this condition are enrolling at a faster pace than expected, according to the company.

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Interim data from Phase 1/2 trial for wet AMD therapy

4D Molecular Therapeutics announced interim data from its Phase 1/2 trial evaluating 4D-150 as a therapy for wet AMD. According to the company’s press release, the treatment showed consistent and durable benefits in visual acuity, control of retinal anatomy, and reduction in treatment burden in three patient cohorts in an up to 2-year follow-up period. It continued to be well tolerated with no new safety or inflammatory findings. 4D-150 is designed to “provide multi-year and potentially life-long sustained delivery” of aflibercept and anti-VEGF-C in a single intravitreal injection. The company is currently enrolling for its second Phase 3 trial.

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Company news

• MeiraGTx entered into a collaboration with Eli Lilly to grant the latter worldwide exclusive rights to is AAV-AIPL1 program under investigation for treatment of ophthalmic genetic conditions.
• PolyActiva and RareSight entered into a collaboration to advance therapies for rare pediatric retinal diseases that don’t currently have approved treatments.

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ASCRS news and events

• 2026 ASCRS Annual Meeting: Register now for the 2026 ASCRS Annual Meeting in Washington, D.C., April 10–13, 2026. Get involved with the meeting by submitting a case video—learn more.
• SightLine at ASCRS: Connect, collaborate, and confront the challenges shaping the commercial landscape of ophthalmology at this meeting taking place Thursday, April 9 ahead of the ASCRS Annual Meeting. This meeting is for all commercial stakeholders in ophthalmology to learn about care delivery ideas that will forge a more sustainable financial future. Learn more.
• Business of Interventional Glaucoma: Surgeons and practice administrators alike are invited to the ASOA ASCRS Business of Interventional Glaucoma program, taking place Thursday, April 9 ahead of the ASCRS Annual Meeting and ASOA Annual Meeting. Learn more.

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Research highlights

• Three IOLs deemed enhanced monofocals were compared to a standard aspheric monofocal in a randomized, comparative study published in the Journal of Cataract & Refractive Surgery. The study included 344 eyes of 172 patients that were randomly assigned to receive TECNIS Eyhance (Johnson & Johnson Vision), Vivinex Impress (Hoya), Nexload NSP-3 (Nidek), or TECNIS Optiblue monofocal (Johnson & Johnson Vision). Monocular and binocular DCVA at far, intermediate, and near were evaluated, as well as photopic and mesopic contrast visual acuity and evaluation of halo and glare symptoms. The investigators found that the three enhanced monofocal IOLs provided better intermediate visual acuity compared to the traditional monofocal with no significant contrast sensitivity issues or photic symptoms. The authors suggest that “enhanced monofocal IOLs can serve as a replacement for standard monofocal IOLs.”
• A prospective, consecutive, interventional case series of 69 patients (75 eyes) that had modified Yamane intrascleral haptic fixation surgery evaluated its long-term effects on lens stability and on surrounding tissues. The study, published in the American Journal of Ophthalmology, had a median follow-up of 3.3 years and, during this time, there were no cases of IOL dislocation. Postop UCDVA and BCVA were significantly improved compared to preop levels. There were some changes in tissue thickness around the haptics, but the authors wrote that this might contribute to IOL stability. The authors noted conjunctival thinning over areas of flange exposure, necessitating a flange to be fully positioned in scleral tunnels with haptics trimmed, if necessary.

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Product news

• Ryjunea (atropine, 0.1 mg/ml, Sydnexis/Santen) was approved by the U.K. Medicines and Healthcare Products Regulatory Agency for pediatric patients with progressive myopia.

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