First patient enrolled in Phase 3 study of cenegermin-bkbj in NAION

Dompé announced the first patient has been enrolled in a Phase 3 study of cenegermin-bkbj for the treatment of non-arteritic anterior ischemic neuropathy (NAION). This Phase 3 trial will involve more than 130 centers globally, and it is a multicenter, double-blind study comparing cenegermin-bkbj against placebo in improving vision loss caused by NAION. According to the company’s press release, the study will enroll approximately 272 patients with NAION aged 50–80 years, and endpoints will assess functional and structural changes in the affected eye, as measured by BCVA, visual field testing, and OCT.

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New AI-powered digital health platform

Bausch + Lomb announced the creation of Orphia, a new AI-powered digital health platform, which the company said is built on the belief that eyecare providers should spend less time managing disconnected tools and technologies and more time caring for patients. The platform is brand agnostic and designed to serve all eyecare providers, regardless of the products, devices, or treatments they choose to use. Orphia will operate under a newly created platform at Bausch + Lomb—Digital Health Services. According to the company’s press release, the initial offering will focus on pre-surgery cataract education, with additional AI capabilities for ophthalmology planned over time.

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FDA Advisory Committee meeting for discussion of low-dose atropine therapy

Sydnexis announced that the FDA intends to convene an Advisory Committee meeting to discuss SYD-101, an investigational low-dose atropine therapy for the treatment of pediatric progressive myopia. The date of the meeting has not been set, but discussion is expected on various aspects of the company’s application, including findings from the Phase 3 STAR study. The Phase 3 STAR trial’s primary efficacy endpoint was the proportion of patients with confirmed progression of –0.75 D, and a key secondary endpoint was annual progression rate. According to the press release, “SYD-101 0.01% successfully met both the primary endpoint (p=0.0226) and the key secondary endpoint (p<0.001). Additionally, SYD-101 was well tolerated with no unexpected atropine-related adverse events.” SYD-101 is approved in the European Union and U.K. (licensed to Santen S.A. and marketed as Ryjunea).

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Selection of lead clinical candidate for gene therapy for Stargardt disease

Atsena Therapeutics announced the selection of a lead clinical candidate for ATSN-401, a potential best-in-class gene therapy for Stargardt disease. The company is advancing ATSN-401 in IND-enabling studies. The press release noted that there is currently no approved treatment to address the underlying cause of Stargardt disease. According to the press release, the “proprietary dual-vector platform delivers full-length ABCA4, enabled by Atsena’s laterally spreading AAV.SPR capsid for delivery to the central retina without foveal detachment.”

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ASCRS news and events

• ASCRS Live!: This educational dinner series is heading to several cities across the U.S. in 2026. Register for the next event, August 6, in Oklahoma City, Oklahoma.
• ASCRS Annual Meeting: Hotel rooms are now available for the 2027 ASCRS Annual Meeting. Book your 2027 hotel in San Diego early to get your preferred room and location.
• eyePAC: Support eyePAC, ASCRS’ political action committee (PAC), which helps protect cataract surgery and preserves surgeons’ ability to deliver high-quality care.*

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EyeWorld article of the week

The YES Connect column in the Spring issue of EyeWorld features two physicians discussing the importance of learning different technologies and techniques in training. Read the article.

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Research highlights

• A study published in the Journal of Cataract & Refractive Surgery sought to evaluate the effects of extracorporeal ultra-high-fluence corneal cross-linking (ECO-CAIRS) on the dehydration and rehydration behavior of porcine corneal stromal ring segments in an experimental model simulating the preparation of corneal allogenic intrastromal ring segments. Corneal ring segments (two per cornea) were prepared from freshly enucleated porcine corneas (n=48) and randomly divided into three groups: controls (no CXL, Jerky technique), extracorporeal ultra-high-fluence CXL at 30 J/cm², and 60 J/cm² (n=32 each). The study found that baseline structural thickness values did not differ significantly between groups. “Both CXL-treated groups demonstrated significantly greater dehydration (p<0.01) and reduced rehydration (p<0.01) when compared to controls,” the authors wrote. “No significant differences were found between the two CXL-treated groups. Ultra-high-fluence cross-linking enhanced segment dehydration and slowed rehydration.” The authors noted that further in vivo studies are needed.
• A prospective, multicenter cohort study, conducted at two academic centers in the U.S. sought to characterize longitudinal ocular symptom trajectories after refractive surgery, as well as describe associated symptom descriptors over time and identify baseline factors associated with pain trajectories. The study was published in JAMA Ophthalmology and included adults undergoing bilateral LASIK or PRK from April 2021–July 2025. The authors noted that among 326 participants with complete pain data (mean [SD] age, 34.3 [7.9] years; 196 [60.1%] female), pain trajectories were heterogeneous. Additionally, “no clinically relevant pain was observed in 94 participants (28.8%), pain at POD 1 only in 143 participants (43.9%), and prolonged pain (at POM 3 or POM 6) in 59 participants (18.1%); 30 participants had uncommon pain trajectories.” Prolonged pain was independently associated with PRK and several preoperative factors, including lubricating drop use, chronic low back pain, and greater ocular symptom burden. Additionally, corneal staining at 6 months after surgery was associated with lower odds of prolonged pain. The study concluded that postoperative ocular symptom trajectories after refractive surgery followed distinct longitudinal patterns. “This trajectory-based, symptom-specific approach may provide clinically relevant insight into patient recovery and may improve risk stratification, counseling, and targeted perioperative management, but further corroboration is warranted,” the authors wrote.

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Product news

• Tenpoint Therapeutics announced the submission of a Marketing Authorization Application to the United Kingdom’s Medicines and Healthcare products Regulatory Agency for the review and approval of YUVEZZI (carbachol and brimonidine tartrate ophthalmic solution, 2.75%/0.1%), a once-daily, dual-agent drop for the treatment of presbyopia in adults.

*Contributions to eyePAC are entirely voluntary and are not tax deductible. Only ASCRS members who are citizens or legal residents of the United States may contribute. eyePAC must obtain, maintain and report the name, address, occupation, and employer of each contributor who gives more than $200 in a calendar year.

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