Topline Phase 3 results for low-dose atropine drop

Sydnexis announced presentation of its topline results from its Phase 3 trial evaluating SYD-101 (0.01% atropine) for treatment of progressive pediatric myopia. The company stated that the drop is designed to have “enhanced ocular delivery characteristics and room-temperature stability.” The study included 847 patients aged 3–14 with myopia of –0.50 to –6.00 D and mean baseline progression of –2.65 D. According to the company’s press release, the randomized (SYD-101 0.01%, SYD-101, 0.03%, or placebo) trial met both its primary and secondary endpoint of proportion of patients with confirmed progression of –0.75 D at 36 months and mean myopic annual progression rate at 36 months, respectively. The study found the drop to be well tolerated without any atropine-related adverse events. Last week, the FDA issued a complete response letter to the company rejecting its New Drug Application for SYD-101. The company plans to meet with the FDA to discuss next steps. The drop is approved in the E.U. and marketed as Ryjunea.

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12-month data from prospective pilot study assessing aqueous shunt

Avisi Technologies announced presentation of its 12-month clinical data from its prospective pilot study assessing safety and efficacy of the VisiPlate Aqueous Shunt for patients with open-angle glaucoma. According to the company’s press release, the study took place at three centers with three surgeons in South Africa, treating 15 patients who had no prior filtration surgery history. The implantation of the VisiPlate was unilateral, ab externo, and standalone. The company reported a mean baseline diurnal IOP of 24.1±6.2 mm Hg. Baseline medications were 2.0±1.5, and baseline visual field mean deviation was –11.7±8.6 dB. After 12 months postop, mean diurnal IOP reduced to 13.1±2.6 mm Hg on 1.3±1.5 medications, equating to a 42.6% reduction in IOP from baseline. The company also reported that 46.7% of participants were not on any IOP-lowering medications at 12 months. There were no serious adverse events and no incidents of persistent vision loss among participants.

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5-year follow-up data supports safety, tolerability of investigational retinitis pigmentosa treatment.

Nanoscope Therapeutics announced positive long-term safety data from its 5-year follow-up study of patients who received MCO-010 for treatment of retinitis pigmentosa in a Phase 1/2a trial. The study followed these 10 participants and confirmed that MCO-010 was safe and well tolerated over this longer timeframe. In a press release, the company reported no serious adverse events or new safety signals; it stated that quality of life was improved during this timeframe. Last week the company also announced positive 3-year follow-up data from its Phase 2b/3 for MCO-010 as a single intravitreal injection for treatment of retinitis pigmentosa.

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Randomization achieved in registrational trial for wet AMD therapy

Ocular Therapeutix announced that it achieved its randomization target of 555 participants in the second registrational trial for AXPAXLI (OTX-TKI) for treatment of wet AMD. The company stated in a press release that it will continue to allow randomization of already enrolled participants who are in the loading phase of the trial. According to the company, this trial along with its other trial will serve as the basis for a potential New Drug Application submission. This trial is a Phase 3, multicenter, double-masked, and randomized 2:2:1 to evaluate AXPAXLI dosed every 6 months, comparing it to aflibercept, 2 mg, dosed every 8 weeks in treatment-naïve patients. The primary endpoint will be non-inferiority in mean change in BCVA from baseline at week 56. Topline results for this second trial are expected in the first half of 2027. The company’s first registrational trial is designed to be a superiority study evaluating a single injection of AXPAXLI compared to a single injection of aflibercept, 2 mg. The topline results from this trial are expected in the first quarter of 2026.

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BLA submitted for thyroid eye disease treatment

Viridian Therapeutics announced its submission of a Biologics License Application (BLA) to the FDA for veligrotug, a treatment for thyroid eye disease that has a breakthrough therapy designation. According to the company’s press release, veligrotug is a novel, fully human monoclonal antibody that in pivotal clinical trials showed improvement in proptosis, diplopia, and other measures of disease activity. The company reported that FDA acceptance of the BLA filing is expected within 60 days of the submission.

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Company news

• Celularity and DefEYE have partnered to advance regenerative therapies in eyecare.
• Samsung Bioepis entered into an asset purchase agreement with Biogen for BYOOVIZ (ranibizumab) and OPUVIZ (aflibercept) in Europe.

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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.
• ASCRS Live!: This educational dinner series has already made its way to several cities across the U.S. in 2025. Registration is open for the final event in Dallas, Texas, on November 13.

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Research highlights

• The clinical performance of the Light Adjustable Lens (LAL, RxSight) and the LAL+, the latter of which has an increase in central power to provide some extended depth of focus, was the subject of a prospective, non-randomized, non-masked, multicenter trial that took place at private practice clinics. The study, published in the Journal of Cataract & Refractive Surgery, found that 91.1% and 93.5% of LAL and LAL+ eyes, respectively, had a manifest refraction spherical equivalent within 0.5 D of target, while 92% and 89% of LAL and LAL+ patients achieved binocular UDVA of 20/20 or better post-adjustment. When it came to binocular uncorrected best focus visual acuity, the authors found that 86% and 93% of LAL and LAL+ patients, respectively, achieved J1 or greater at 100% contrast. They also found intermediate and near corrected visual acuity were better with the LAL+. BCDVA was reduced by 1 letter with the LAL+. The authors concluded that both lenses “achieved excellent refractive and binocular visual outcomes at distance, intermediate, and near” and that the “broadened [depth of focus] of the LAL+ was clinically evident and led to less anisometropia.”
• A double-masked, placebo-controlled crossover randomized study sought to determine whether oral nicotinamide (NAM) supplementation could improve retinal function in normal tension glaucoma patients who were on IOP-lowering therapy. The study, published in the British Journal of Ophthalmology, included 53 patients who received oral placebo or NAM, followed by a crossover without a washout period. Treatments were administered as NAM/placebo 1 g/day for 6 weeks, then 2 g/day for another 6 weeks. Retinal function was measured with full-field electroretinography and visual field testing. The investigators found that after 12 weeks, the “photopic negative response in peak-to-trough and the B-wave were significantly greater in the NAM group … compared with the placebo group,” which they wrote in their conclusion supports the “induced functional improvement” with NAM supplementation. They, however, noted that normal tension glaucoma having a lower IOP could show weaker electrophysiological activity and slower progression, meriting longer studies on the effects of NAM in this patient population.

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