New designations granted to investigational treatment for retinal dystrophies

Nanoscope Therapeutics announced that it received a Regenerative Medicine Advanced Therapy designation from the FDA for MCO-010 (sonpiretigene isteparvovec) for Stargardt disease, in addition to the FDA Orphan Drug designation it has for Stargardt disease and the Fast Track designations that it has for both Stargardt disease and retinitis pigmentosa. The company also received five Orphan designations from the European Medicines Agency for “non-syndromic and syndromic rod-dominant and cone-dominant dystrophies, as well as macular dystrophies.” These designations, according to the company, provide “a potential disease-agnostic regulatory path forward for dozens of retinal conditions.” The company previously announced positive results from its Phase 2b/3 trial investigating the one-time, in-office therapy for retinitis pigmentosa and “encouraging findings” in its Phase 2 trial for Stargardt disease. A Phase 3 trial for Stargardt disease and a Phase 2 trial for geographic atrophy are expected to begin by the end of this year.

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Status update on BLA for bevacizumab for treatment of retinal diseases

Outlook Therapeutics was issued a complete response letter for its biologics license application (BLA), a resubmission, to the FDA for ONS-5010 (bevacizumab-vikg) for treatment of wet AMD. According to the company’s press release, the FDA indicated that it could not approve the application because it did not meet its primary efficacy endpoint in one of its studies, acknowledging that its primary endpoint for efficacy was met in another study. The company later announced that it requested a Type A meeting with the FDA to gain clarity on the confirmatory evidence required by the FDA to support resubmission of an application for ONS-5010. The company noted that it has marketing authorization for LYTENAVA (bevacizumab gamma) for treatment of wet AMD in the E.U. and the U.K.

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Acquisition news

Alcon announced its completed acquisition of LumiThera. According to the company’s press release, the acquisition includes the Valeda photobiomodulation device for treatment of early and intermediate dry AMD and a subset of late dry AMD. The system is currently available in the U.S. and some European and Latin American countries. Alcon plans to expand into other approved markets and into additional markets, pending regulatory approvals, in 2026, according to the press release.

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ASCRS news and events

• Business of Refractive Cataract Surgery (BRiCS) Summit: This course, taking place October 3–5, in Chicago, Illinois, along with its extensive, take-home Resource Library, will help practices gain the navigational tools needed to increase premium IOL adoption and lead patients effectively on their refractive surgery journey. Learn more.
• ASCRS Live!: This educational dinner series is heading to several cities across the U.S. in 2025. Registration is open for the next event in Philadelphia on September 11.
• 2026 ASCRS Annual Meeting: Hotel room blocks are open for the 2026 ASCRS Annual Meeting, taking place in Washington, D.C., April 10–13, 2026. The call for submissions is also ongoing until September 18. Submit an abstract and get involved in the 2026 ASCRS Annual Meeting.

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Research highlights

• The outcomes of two different IOLs implanted with a modified Yamane technique were evaluated in a retrospective study published in the Journal of Cataract & Refractive Surgery. The study included 25 patients who received the Alcon MA60AC lens (Group A) and 25 who received the Sensar AR40e lens (Group S) for treatment of aphakia or single-piece lens subluxation. The authors reported no statistically significant differences in terms of age, sex, axial length, or IOL power. Significant improvements in uncorrected and corrected visual acuity occurred in both groups. At 6 months postop, Group A and Group S had a spherical refractive value of +0.75±0.48 D and –0.56±0.49 D, respectively. Deviation from refractive target was 1.71±1.35 D in Group A and 0.65±1.54 D in Group S. There was no significant difference in cylindrical refraction between the groups. There were no IOL-specific complications, according to the authors, but they noted one case of CME and one case of retinal detachment in Group A, and one case of CME and one case of pseudophakic bullous keratopathy in Group S. Each group experienced one case of intraoperative haptic damage. The authors concluded that the modified Yamane technique “could be performed effectively and safely with polymethylmethacrylate haptic IOLs,” though “each IOL may require specific modifications for the target refraction.” The authors also noted that to their knowledge this was the first study to compare real-world outcomes of two IOLs using a modified Yamane technique.
• A retrospective cohort study published in JAMA Ophthalmology suggests that glucagon-like peptide-1 receptor agonists (GLP-1RAs) could have a protective effect against uveitis. The study used EHR data from 2006–2025, identifying patients who used GLP-1RAs, metformin, insulin, or sodium-glucose cotransporter 2 inhibitors (SGLT2is) and comparing the incidence of non-infectious uveitis to patients who did not take any of these medications. There were 258,025 in the GLP-1RA group and 258,026 in the control group. The GLP-1RA group showed a reduced risk of uveitis compared to controls, with consistency in this among those who had type 2 diabetes and those who didn’t. The patients who were taking GLP-1RAs had lower incidence of uveitis compared to those on metformin and insulin, but the authors noted that GLP-1RAs were associated with a “slightly increased uveitis risk vs. SGLT2is,” the latter of which was also associated with reduced uveitis risk compared to control. The authors concluded that GLP-1RAs could have “anti-inflammatory benefits beyond glycemic control, warranting further investigation into their role in ocular inflammatory diseases.”

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Product news

• New World Medical launched the Ahmed ClearPath ST, a non-valved glaucoma drainage device that has a smaller tube lumen than the prior model and is pre-threaded with a 6-0 Prolene ripcord suture and a 25-gauge needle for scleral tunneling.
• Plexitome Medical and VEO Ophthalmics partnered to launch Plexitome, a device for anterior stromal puncture. The company’s press release stated that the device “features a 6.2 mm diameter disc array with approximately 675 precisely engineered micro-spikes” and “up to 3,375 individual epithelial attachment points created over five imprints.”
• VirtuaLens launched its Immersive IOL Simulator, a virtual reality platform that showcases different IOL options to prospective cataract patients.
• BVI announced its plans to introduce Virtuoso, a dual-function phaco-vitrectomy system for cataract and vitreoretinal surgery in Europe at the Euretina and ESCRS congresses.

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