Complete response letter issued for low-dose atropine drop

The FDA issued a complete response letter to Sydnexis for its New Drug Application (NDA) for SYD-101 (0.01% atropine) for treatment of progressive pediatric myopia. According to the company’s press release, its NDA was supported by a Phase 3 trial that included more than 800 pediatric participants, met its primary efficacy endpoint (proportion of patients with confirmed progression of –0.75 D), and met statistical significance in its secondary endpoint (annual progression rate). The FDA in the complete response letter stated that while the primary endpoint was met, it didn’t think the data supported the efficacy of low-dose atropine for children with myopia, according to Sydnexis. The letter did not note any safety or product quality issues. The company’s CEO said in a statement that Sydnexis would work with the FDA to address the complete response letter and determine the path forward toward FDA approval for SYD-101. SYD-101 is approved in the European Union, licensed to Santen and marketed as Ryjunea.

Back to top

Extension study shows reduced GA growth with intravitreal treatment

Astellas Pharma announced the results from its open-label extension trial for its Phase 3 study of IZERVAY (avacincaptad pegol intravitreal solution) for treatment of geographic atrophy (GA) secondary to AMD. According to the press release about the results, GA growth was reduced 37–40.5% compared to sham in the 18-month extension trial. A reduction in GA lesion growth for up to 3.5 years with IZERVAY was associated with earlier interventions. Over this timeframe, there were no cases of retinal vasculitis or occlusive vasculitis, with the treatment remaining well tolerated, according to the company. The company noted that real-world data from more than 10,000 U.S. patients with GA supports the safety and tolerability of the treatment with low rates of discontinuation and adverse events.

Back to top

Durable, 3-year vision improvements seen with optogenetic therapy

Nanoscope Therapeutics announced positive 3-year follow-up data from its Phase 2b/3 trial evaluating MCO-010 for treatment of retinitis pigmentosa (RP). The treatment showed sustained, 3-line vision gains compared to baseline among patients who had severe vision loss from RP. A favorable safety profile was maintained as well. The company stated in a press release that the data from this extension trial forms the basis for a rolling Biologics License Application, which was initiated in June 2025. If approved, this would be the first optogenetic therapy. The MCO platform, according to the company, is considered disease agnostic, designed to address vision loss for patients with RP, Stargardt disease, and geographic atrophy by activating bipolar retinal cell to become light sensitive.

Back to top

Preclinical data supports long-acting nature of investigational anti-VEGF for wet AMD

Preclinical data from Valitor for VLTR-559 could support a 6-month dosing schedule, according to a press release from the company. The company stated that the treatment has a “substantially longer ocular half-life, with high drug concentrations retained in the retina compared to current anti-VEGF standard of care.” More specifically, the company stated that VLTR-559 was maintained 3x longer than aflibercept in preclinical models. It was also well tolerated with a similar safety profile to already approved anti-VEGF therapies. According to the company, VLTR-559 uses Valitor’s proprietary multivalent polymer technology with the intent for redosing twice per year.

Back to top

Company news

• Eli Lilly and Adverum Biotechnologies announced Eli Lilly’s intent to acquire Adverum Biotechnologies and its lead product candidate, Ixo-vec, a Phase 3 gene therapy intended for vision loss associated with wet AMD.
• Locus Biosciences and Viatris entered into a research collaboration agreement to develop novel engineered bacteriophage products to target ophthalmic bacterial infections.

Back to top

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 Grand Rounds: The latest episode of ASCRS Ground Rounds, presented by Eastern Virginia Medical School, is available on demand.

Back to top

Research highlights

• A lack of standardized guidelines for DMEK prescriptions in Europe was revealed due to varying prescription patterns as observed in a cross-sectional European survey study. The research published in the Journal of Cataract & Refractive Surgery included countries affiliated with the European Cornea and Cell Transplantation Registry and the European Vision Institute Clinical Research Network. A survey was sent to 16 societies to gather prescription patterns for DMEK from among membership. The survey yielded 136 surgeon responses and found that “medication protocols came mainly from departmental protocols (54%) or personal experiences (48%) rather than national guidelines (22%)”; the authors noted that multiple answers were allowed. Intraoperative and postoperative antibiotics were the most common forms of infection prevention (more so than preop interventions). Similarly, steroids were used intraoperatively and/or postoperatively to prevent graft rejection, with dexamethasone being the preferred steroid. When DMEK was high risk, another topical steroid (30%) or systemic immunosuppressive (24%) were often employed. When graft rejection occurred, 85% of respondents increased frequency of topical steroids or added steroid injections (42%). To prevent pupillary block and glaucoma, intraoperative mydriatics were used among 34% of respondents, while IOP-lowering drops were between 0.7–2.2%. If steroid-induced ocular hypertension occurred, 40% of respondents switched to a lower strength steroid or reduced its dosing frequency (43%).
• An open-label, multicenter, prospective, single-group, baseline-controlled study evaluated the vision of patients with geographic atrophy and visual acuity of 1.2 logMAR or greater, after engaging a photovoltaic retina implant microarray (PRIMA) system intended to restore sight in areas of central retinal atrophy. The PRIMA system, which includes a subretinally placed photovoltaic implant and wearable glasses that project near-infrared light to the implant, was assessed in 32 patients at 12 months. The investigators found that there was a clinically meaningful improvement in visual acuity from baseline in 26 of the 32 assessable patients. There were 26 serious adverse events in 19 patients; 21 of these events occurred within the first 2 months of surgery and most (20) were resolved within 2 months. Six patients who had the implant were not assessed due to death, withdrawal, or being unavailable for testing. The research is published in the New England Journal of Medicine.

Back to top

Product news

• VEO Ophthalmics entered into a strategic partnership with PeriVision to launch the VisionOne AI Visual Field Platformin the U.S.

Back to top

---