Enrollment complete in Phase 3 trial for wet AMD

Ahead of its goal date, 4D Molecular Therapeutics announced that enrollment is complete in its Phase 3 registrational trial evaluating treatment of wet AMD with intravitreal 4D-150 (investigational) compared to aflibercept 2 mg (control). According to the company’s press release, the trial at this point is overenrolled, exceeding the anticipated 500 patients needed to be randomized. The study aims to establish non-inferiority in mean change from baseline in BCVA at 52 weeks with 4D-150 compared to aflibercept. A secondary endpoint is treatment burden reduction, looking at the number of aflibercept injections during the study timeframe. Topline results are expected in the first half of 2027. A second Phase 3 trial will be similar in design to this first registrational trial, except it will include enrollment of treatment-naïve patients and those recently diagnosed wet AMD patients who had received treatment; enrollment for this trial is expected to be complete in the second half of this year with topline results in the second half of 2027. According to the company’s press release, 4D-150 is intended to provide “multi-year, and potentially lifelong, sustained delivery of anti-VEGF biologics” in a single injection.

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Dosing complete in Phase 1/2 trial for retinitis pigmentosa treatment

The dosing of 33 patients enrolled in a Phase 1/2 trial evaluating SPVN06, an AAV vector-based, mutation-agnostic gene therapy for treatment of retinitis pigmentosa, is complete. According to the press release from SparingVision, 27 patients received the SPVN06 injection, and 6 received a control dose. The trial will assess safety and exploratory efficacy endpoints, according to the company. There is a dose-escalation part of the study where 9 patients received 3 doses of SPVN06. The rest of the patients were randomized to receive one of two doses of SPVN06 or control. Data from this study is expected to be shared in 2026 with the goal of beginning a pivotal trial in 2027. The study described SPVN06 as gene therapy that is “comprised of one neurotrophic factor (Rod derived Cone Viability Factor, RdCVF) and one enzyme reducing oxidative stress (Rod derived Cone Viability Factor Long form, RdCVFL).” These elements are meant to act synergistically to slow or stop the degeneration of cone photoreceptors.

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First patient dosed in gene therapy study for optic nerve disorder

Stoke Therapeutics dosed its first patient in a Phase 1 study evaluating STK-002 as a possible treatment for autosomal dominant optic atrophy (ADOA), a rare, inherited disorder of the optic nerve with no currently approved treatments. The Phase 1 study is a dose-escalation, open-label study that includes children and adults age 6–55 with ADOA and a confirmed mutation in the OPA1 gene. The primary objectives are safety and tolerability of single ascending doses and exposure in the blood. Secondary objectives are changes in visual function, ocular structure, and quality of life after a single dose. Dose escalation in the study, if safe and tolerable, is expected to continue through 2026 and into early 2027. STK-002 is a “proprietary antisense oligonucleotide,” designed to “upregulate OPA1 protein expression by leveraging the non-mutant (wild-type) copy of the OPA1 gene to restore OPA1 protein expression with the aim to maintain or improve vision in people with ADOA,” according to the company.

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Company news

• ZipBio entered into an exclusive license agreement with MeiraGTx Holdings in which MeiraGTx will receive exclusive rights to ZipBio’s first-in-class therapies for geographic atrophy.

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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

• Two crosslinking protocols—the Tel-Aviv Protocol, which combines accelerated crosslinking with epithelial PRK, and the Athens Protocol, which combines accelerated crosslinking with topography-guided PRK—for treatment of keratoconus were compared in a multicenter, retrospective, comparative study published in the Journal of Cataract & Refractive Surgery. Thirty-five eyes of 35 patients received the Tel-Aviv Protocol, while 60 eyes of 60 patients received the Athens Protocol. Both groups saw an improved UDVA, CDVA, astigmatism, and Kmax. The Tel-Aviv Protocol had a significant improvement in spherical equivalence, while propensity score matching (which adjusted for differences in baseline characteristics between the two groups) showed that the Athens Protocol yielded a 1.84 D greater reduction in Kmax and a 19.44 μm greater minimal corneal thickness reduction compared to the Tel-Aviv Protocol. The Tel-Aviv Protocol group had a 3.4-line greater improvement in UDVA compared to the Athens Protocol group, according to the investigators. They concluded that both protocols resulted in improved visual and topographic outcomes. While the Tel-Aviv Protocol yielded better visual gains, the Athens Protocol saw greater corneal flattening. The authors concluded that the Tel-Aviv Protocol could be better for patients with thinner corneas due to less stromal tissue ablation.
• A secondary analysis of the Zoster Eye Disease Study that focused on stromal keratitis (SK) sought to evaluate the outcomes of recurrent, new, or worsening SK in patients with herpes zoster ophthalmicus (HZO) with use of oral valacyclovir and topical steroid. According to the paper, recurrent, new, or worsening SK occurred in 20% of participants, and being randomized to the valacyclovir group or placebo in the original study was not associated with SK. Masked investigators treated 10% of the SK cases with open-label oral antiviral. The authors noted that when SK was identified (usually during one of the study’s scheduled visits), 50% of patients were already on a topical steroid but 90% of these patients on the topical steroid were using them one time per day or less. In the 47% of patients not on topical steroids when recurrent, new, or worsening SK was diagnosed, 38% had discontinued their steroids in the 3 months prior to the diagnosis. Of the patients who were not on topical steroids at the time of SK diagnosis, 75% were treated with high-potency steroids twice daily (or more). Some patients were on a low-potency steroid at the time of SK diagnosis, and these patients (50%) were told to increase frequency of this steroid use, according to the authors. The authors concluded that patients with HZO who develop SK can maintain good vision without the use of oral therapy, and low-potency topical steroids should be considered for treatment and suppression of SK. This study was published in the American Journal of Ophthalmology.

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Product news

• Nordic Pharma launched Lacrifill, an intracanalicular, cross-linked hyaluronic acid gel, in the European market.
• AEYE Health expanded deployment of its integration of AEYE-DS for diabetic eye exams with the Epic electronic medical record platform. This integration, according to the company, provides portable AI screening for ordering of exams and results within Epic in under 1 minute. The company also noted that these screenings are reimbursable under the first AI-specific reimbursement code in the U.S., 92229.

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