FDA approves new viscoelastic system

New World Medical received FDA 510(k) clearance for its VIA360 Surgical system, which the company described as “for the delivery of controlled amounts of viscoelastic during ophthalmic surgeries.” The system is also indicated to cut the trabecular meshwork in trabeculotomy procedures combined with cataract surgery or standalone.

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Expanded label approved for geographic atrophy treatment

Astellas Pharma announced that the FDA expanded prescribing information in the U.S. for IZERVAY (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy secondary to AMD. With this expanded label, the drug is now approved without limitation on duration of dosing, giving providers and their patients more flexibility for their disease management.

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Biologics application accepted for aflibercept biosimilar

Alvotech and Teva Pharmaceuticals announced that the FDA accepted its Biologics License Application for AVT06, a biosimilar to Eylea (Regeneron, aflibercept, 2 mg) for treatment of retinal diseases, such as wet AMD, diabetic retinopathy, and macular edema. Regulatory approval, according to the company, would be expected by the end of this year.

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Update on gene therapy program

Opus Genetics provided an update on its gene therapy program for inherited retinal diseases. Among the updates were that its first pediatric patient with Leber congenital amaurosis was dosed in the company’s ongoing Phase 1/2 trial evaluating OPGx-LCA5. This trial has already started showing meaningful visual improvement as early as 1-month post-treatment in the first 3 adult patients. The company expects to release 12-month data on these three adult patients in the second quarter of 2026. The company also stated that it has scheduled an FDA Type D meeting in March to discuss pivotal trial design and endpoints.

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ASCRS news and events

• 2025 ASCRS Annual Meeting: Registration is open for the ASCRS Annual Meeting, taking place April 25–28, in Los Angeles, California. Find the most up to date information here: Real-Time Program.
• SightLine at ASCRS: This is a new day-long meeting April 24, ahead of the ASCRS Annual Meeting, for all commercial stakeholders in ophthalmology to learn about and collaborate on technologies and 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 24 from 1:00–5:30 p.m. in Los Angeles ahead of the ASCRS Annual Meeting and ASOA Annual Meeting. Learn more.
• ASCRS 50th anniversary: ASCRS members from the 50 states are sending in their perspectives on the Society, its impact on their career, and its influence on the specialty as a whole. Tune in each week through April 2025 for a new video.

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Research highlights

• Variability among different automated biometric devices to inform decision making for phakic IOL sizing was evaluated in a private practice, prospective, single-center, bilateral, non-randomized, open-label observational study, comparing the Orbscan II (Bausch + Lomb) to Argos (Alcon), Atlas 9000 (Zeiss), caliper, IOLMaster 500 (Zeiss), IOLMaster 700 (Zeiss), iTrace (Tracey Technologies), Lenstar LS900 (Haag-Streit), Pentacam HR (Oculus), and Pentacam AXL Wave (Oculus). The study included 204 participants (408 eyes). According to the investigators, all mean white-to-white measurements, except that obtained with the Pentacam AXL Wave, were significantly different compared to Orbscan. All mean anterior chamber depth and central corneal thickness measurements were also significantly different compared to the Orbscan. The authors concluded that “biometers tested were not interchangeable with Orbscan II” and that “adjustment factors for [white-to-white] and [anterior chamber depth] may compensate for differences between devices and adapt ICL sizing recommendations. The study was published in the Journal of Cataract & Refractive Surgery.
• A focus group and prospective audit published in the journal Eye sought to identify single-use pack items in cataract surgery that could be streamlined or replaced with reusable alternatives and the carbon impact of such a transition. According to the authors, the “total carbon savings from streamlining was 935 kgCO2e/year, and switching, was 309 kgCO2e/year.” The authors noted that single-use items had a 27-time greater carbon footprint compared to reusables. The “net carbon saving was achieved from 19 or more re-uses of the reusable items compared to single-use equivalents,” the authors wrote.

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Product news

• Optos announced the launch of MonacoPro, its next-generation ultra-widefield and spectral domain retinal imaging device, which will begin shipping in March 2025.
• Alcon announced the U.S. launch of its Voyager DSLT (direct selective laser trabeculoplasty device) for treatment of glaucoma.
• Glenmark Pharmaceuticals launched a generic latanoprost ophthalmic solution, 0.005%, which the company states is bioequivalent and therapeutically equivalent to Xalatan (Viatris).

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