FDA approval for treatment of wet AMD

Outlook Therapeutics announced that the U.S. FDA approved LYTENAVA (bevacizumab-vikg) for the treatment of neovascular age-related macular degeneration (nAMD). The company’s press release noted that, “for the first time, retina specialists and patients have access to an FDA-approved ophthalmic bevacizumab developed specifically for the eye and supported by rigorous clinical evidence, validated manufacturing, approved labeling, comprehensive quality systems, and ongoing FDA regulatory oversight.” The company is now executing the commercial launch and expects to make LYTENAVA available to eligible patients in the U.S. by the end of the year.

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Patient enrollment complete for 510(k) pivotal study for microshunt

Glaukos announced the completion of patient enrollment in its U.S. 510(k) pivotal study evaluating the PRESERFLO MicroShunt in adult patients with primary open-angle glaucoma (POAG) who failed previous medical and surgical treatment. According to the company’s press release, this prospective, multi-center, single-arm clinical trial enrolled patients who had previously undergone unsuccessful incisional or cilioablative glaucoma surgery and whose IOP remained inadequately controlled with IOP-lowering medications. The company noted that the study “successfully enrolled its target of at least 110 patients across clinical sites in the United States and Canada. The study’s primary effectiveness endpoint is a 20% or greater reduction in mean diurnal IOP from baseline at 12 months postoperatively without an increase in the number of IOP-lowering medication classes from baseline.” Glaukos intends to use the study results to support a future FDA marketing submission for the PRESERFLO MicroShunt.

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Key findings in using PROSE for NK

BostonSight announced key findings in the use of PROSE for the treatment of neurotrophic keratitis (NK). These findings were noted in a poster presented at the Association for Research in Vision and Ophthalmology’s (ARVO) Annual Meeting. According to BostonSight’s press release, the purpose of this retrospective observational study was to evaluate PROSE treatment as a therapeutic intervention for NK, and the study analyzed data from November 2008 to September 2023 for 87 eyes from 87 patients with NK (Stage 0: n= 8; Stage 1: n=57; Stage 2: n= 17; Stage 3: n=5). “Overall, results demonstrated a statistically significant improvement in Mackie Stage (mean) and Visual Acuity (mean) after PROSE treatment among eyes with NK. The average time to achieve the lowest Mackie Stage was 31.18 days,” the press release stated.

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Successful End-of-Phase 1 Type B meeting for non-atropine eye drop

iVeena Delivery Systems announced a successful End-of-Phase 1 Type B meeting with the U.S. FDA for IVMED-85, an investigational, non-atropine eye drop being developed for the treatment of pediatric myopia. This followed the recently announced successful completion of iVeena’s Phase 1 clinical study evaluating the safety and tolerability of IVMED-85 in healthy adult volunteers. The press release noted that “the FDA confirmed that the Phase 1 clinical data, together with the company’s previously completed nonclinical toxicology program, support advancement into pediatric Phase 2 clinical development.”

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Digital journal invites original case report submissions

The Digital Journal of Case Reports in Ophthalmology (DJCRO), an open access, fully online journal affiliated with Duke Eye Center, is requesting original case reports from ophthalmologists, trainees, and other eyecare professionals worldwide. Authors are invited to share distinctive clinical presentations, diagnostic challenges, innovative management approaches, and other cases that offer valuable lessons for the ophthalmology community.

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Company news

• Yarrow Bioscience announced the completion of its merger with VYNE Therapeutics. The company is advancing YB-101, a potential first-in-class anti-thyroid stimulating hormone receptor monoclonal antibody, designed to directly disrupt the central mechanism of Graves’ disease and thyroid eye disease. The company also announced the initiation of dosing in a Phase 2a/2b trial evaluating YB-101 in patients with Graves’ disease, with or without concurrent TED; the molecule has received Fast Track Designation from FDA. Data from the Phase 2a portion of the trial are expected in the second half of 2027.

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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.*
• ASCRS Position Statement on Cyclodialysis with Scleral Reinforcement: ASCRS has released a new position statement addressing how physicians should report a controlled cyclodialysis with scleral reinforcement procedure using currently available CPT codes—until a dedicated Category III code takes effect on January 1, 2027. Read the full position statement.

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EyeWorld article of the week

• The Summer issue of EyeWorld features an article discussing how simulation can help demonstrate vision with different lens platforms and aid patients in the decision-making process. In “Visual simulators in ophthalmology: available options and functionalities,” several physicians discuss the utility of this technology, as well as specific products. Read the article.

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Research highlights

• A retrospective, single-center study detailed complications from epithelium-off crosslinking for keratoconus, presenting a single institution’s historical experience. The study, published in the Journal of Cataract & Refractive Surgery, identified all patient encounters for epithelium-off CXL performed by eight physicians between January 1, 2018, and September 1, 2023, at two large cornea practices at Wills Eye Hospital, and ultimately, 833 eyes from 670 patients that received CXL via the KXL system (Glaukos) were identified for inclusion. Overall, 31 (3.7%) eyes had persistent epithelial defect (PED), 28 (3.4%) had postoperative infiltrates, and 565 (67.8%) had corneal haze. In multivariable analysis, PED was associated with use of general anesthesia and preoperative corneal scarring. Corneal haze was associated with thicker baseline pachymetry and younger age. No significant risk factors for corneal infiltrates were identified.
• Research published in Ophthalmology sought to identify donor, lenticule preparation, recipient, and operative factors associated with 1-year Descemet membrane endothelial keratoplasty (DMEK) success in the Diabetes Endothelial Keratoplasty Study (DEKS). The prospective cohort study was a pre-specified secondary analysis of the DEKS randomized, double-masked, multicenter clinical trial. Eyes undergoing DMEK were randomized to receive a cornea from a donor without or with diabetes in a 2:1 ratio. The main outcome measure was DMEK success rate at 1 year. The authors noted that, of 1,421 DMEK grafts, 1,374 (97%) were clear at 1 year, 32 were primary donor failures, 12 were early failures, and 3 were late failures. The 78 cases (5.5%) with operative complications had a reduced success rate. “Three additional factors were associated with slightly higher graft success rates in multivariate analysis without reaching the defined statistical significance threshold of P<.01: baseline donor endothelial cell density ≥ 2500 vs. <2500 cells/mm² (97% vs. 95% success, P=.03), tissue peeled by surgeon vs. eye bank (99% vs. 96% success, P=.02), and recipient diabetes status: no vs. yes (97% vs. 94% success, P=.02),” the authors noted.

*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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