Enrollment complete in first-in-human trial evaluating treatment for patients with Usher syndrome

AAVantgarde announced that enrollment is complete for its Phase 1/2, first-in-human trial evaluating AAVB-081 for treatment of retinitis pigmentosa in patients with Usher syndrome type 1B. This is a multicenter, open-label, dose-escalation, and expansion study that will evaluate safety, tolerability, and efficacy of one AAVB-081 injection. According to the company’s press release, this investigational treatment targets the MYO7A gene, the root cause of Usher syndrome type 1B. Further, the treatment has two AAV8 vectors that each have “one half of an expression cassette encoding for the MYO7A gene.” The treatment works by “recombining the two halves of the transgene back into a single one within the cell.” In animal models, this treatment has “[generated] therapeutically meaningful protein levels.”

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First patients randomized in drug-eluting IOL trial

SpyGlass Pharma announced that it has begun randomizing patients in its two Phase 3 registrational clinical trials for its Bimatoprost Drug Pad-IOL System (BIM-IOL System) to lower IOP in patients with open-angle glaucoma or ocular hypertension. The IOL system would be placed at the time of cataract surgery. According to the company’s press release, each trial is expected to enroll about 400 participants, designed to demonstrate non-inferiority of the BIM-IOL System to a standard IOL with topical, twice-daily timolol drops. There are two primary endpoints: time-matched change in mean IOP from baseline and the proportion of patients with a BCDVA of 20/40 or better. Participants will be monitored for up to 36 months.

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Preliminary data from Phase 2 gene modifier study for geographic atrophy

Ocugen announced preliminary, 12-month data from its Phase 2 trial evaluating OCU410 for treatment of geographic atrophy secondary to dry AMD. According to the company’s press release, the gene modifier therapy (both the medium and high dose groups) resulted in a 46% lesion growth reduction at 12 months compared to control. The high dose achieved a 36% reduction in lesion growth while the medium dose achieved a 54% reduction. There was a 50% responder rate compared to the control group. Further data will be reported later this quarter with the Phase 3 trial expected to begin later this year.

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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. View the Preview Program for more information.
• 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

• The performance of a deep-learning implantable collamer lens (ICL) sizing model using SS-OCT images was the subject of a retrospective validation study. The research published in the Journal of Cataract & Refractive Surgery saw patients implanted with the EVO ICL (STAAR Surgical) at two clinics in Europe between October 2019 and April 2024; preop and postop OCT images from these cases as well as other data were included in the model to predict vault, confidence levels, and the probability of achieving a vault between 250–740 μm. These predictions were compared to the actual postop vault; mean absolute error, vault accuracy, and vault distribution were evaluated as well. The study included 848 eyes from 429 patients. The model, according to the investigators, “significantly [outperformed] the STAAR nomogram,” predicting vaults within ±250 μm in 81.7% of cases and ±300 μm in 90.7% of cases. When cases were outside the 250–750 μm range, the model recommended other ICL sizes. The authors concluded that the model “provided accurate ICL sizing predictions and valuable metrics such as P250-750 to assist clinical decision-making. This approach may reduce sizing errors and improve patient outcomes.” They report that the model is already available using the ANTERION SS-OCT system (Heidelberg Engineering) at safevaulticl.com.
• A multi-center, cohort study evaluated the efficacy and safety of repeated low-level red-light therapy (RLRL) for myopia progression over a 3-year period in a real-world setting. The study included electronic medical databases from three hospitals where patients age 7–18 received RLRL; about 90 participants were selected for each analysis group based on treatment duration of ≥0.5–1 year, ≥1–2 years, ≥2–3 years, and ≥3 years. RLRL therapy was administered twice daily 5–7 days/week. According to the authors, the “satisfactory myopia control rate (defined as annual axial elongation ≤0.10 mm) was 72.53% (95% CI 62.17 to 81.37) over ≥3 years of RLRL treatment, with annual axial length change of 0.06 mm/year (95% CI 0.03 to 0.08).” There was no subjective visual function damage and no duration-dependent changes based on objective full-field electroretinogram. There was a “reversible optical coherence tomography change” in four eyes, but this did not impact visual function. The authors concluded that this “real-world study demonstrates that RLRL therapy provides promising long-term efficacy and safety in myopia control over 3 years among Chinese myopic children and adolescents.” The research is published in the British Journal of Ophthalmology.

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Product news

• Eylea 8 mg (aflibercept 8 mg, Bayer) was approved for a third indication—macular edema following retinal vein occlusion—in the European Union.
• The Sophi phacoemulsification system by Rayner received FDA 510(k) clearance to enter the U.S. market. The system, according to the company, features “Triple Pump Fluidics (both peristaltic and venturi), an intuitive user interface, and wireless power concept.”

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