FDA approves epithelium-on crosslinking treatment

Glaukos announced FDA approval of Epioxa, the first epithelium-on crosslinking procedure for keratoconus to be approved in the U.S. Its approval is based on two Phase 3 pivotal trials that randomized more than 400 patients; both trials achieved their primary efficacy endpoints with a favorable safety and tolerability profile. Epioxa is expected to be commercially available in the first quarter of 2026.

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12-month results from Phase 1/2 trial evaluating regenerative cell therapy for corneal endothelial disease

Aurion Biotech presented results from its Phase 1/2 trial for AURN001 (neltependocel with Y-27632 rho-kinase inhibitor) as an investigational treatment for patients with corneal edema secondary to corneal endothelial dysfunction. The dose-ranging study treated patients with one dose of AURN001 and demonstrated a dose-dependent response, with the greatest efficacy in the high-dose group. Sixty-five percent of participants in the high-dose group compared to 0% of the Y-27632 group achieved a 15-letter or greater BCVA gain. The mean change in baseline BCVA in this group was 12.5 letters, there was a mean reduction of central corneal thickness of 23.2 µm, and responders’ visual acuity improved 60–81 letters, according to the company’s press release. Participants in the high-dose group also reported the highest gains in quality of life measures. The study enrolled 97 patients at 20 sites in the U.S. and Canada, randomizing them to receive a high, medium, or low dose, human corneal endothelial cells alone, or Y-27632 alone. A Phase 3 study is expected to begin in 2026.

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Phase 3 data supports nonsteroidal treatment for uveitic macular edema

Genentech announced presentation of its Phase 3 pivotal data for vamikibart (0.25 and 1 mg), an investigational, non-steroidal treatment for uveitic macular edema. According to the company’s press release, vision improvements (the primary endpoint) occurred in both studies with statistical significance reached in one study and nominal significance in the other when compared to the sham treatment. Improvements in average change from baseline BCVA and in central subfield thickness were observed as secondary endpoints. Vamikibart was well tolerated with a low incidence of treatment related adverse events (the most common of which were conjunctival hemorrhage and elevated IOP), according to the company.

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FDA approves IDE for glaucoma device

The FDA has approved VisiPlate from Avisi Technologies for an investigational device exemption (IDE) as the company begins a prospective, multicenter, open-label study. According to the company’s press release, VisiPlate is made from a “novel metamaterial” and is thinner than human hair. It is designed to introduce multiple microchannels to provide sustained aqueous flow while minimizing blockages. The study will evaluate safety and efficacy in glaucoma patients with 1 year of follow-up.

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Company news

• Topcon Healthcare launched IDHea, the Institute for Digital Health, which is dedicated to clinical research in eyecare and oculomics. The goal of IDHea is to build “an interoperable data ecosystem that advances biomarker discovery, translational research, and clinical decision-making.”
• Dompe received a voucher from the FDA Commissioner’s National Priority Voucher program, which will shorten the review timeline for a marketing application (from 10–12 months to 1–2 months) and includes enhanced collaboration with the administration. The company stated that it will apply this voucher to its BLA for intranasally administered cenergermin-bkbj for treatment of non-arteritic anterior ischemic optic neuropathy.
• Y.ora Vision entered into a licensing agreement with the Singapore Eye Research Institute and Eyexora Global to advance its MIGS platform, YRA-01, for mild to severe open angle glaucoma. It is described as a hand-held device designed to perform multiple trabeculotomies.

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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, 2026. Get involved with the meeting by submitting a case video—learn more.
• 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.
• ASCRS Grand Rounds: The latest episode of ASCRS Ground Rounds, presented by Eastern Virginia Medical School, is available on demand.

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Research highlights

• Two papers published in JAMA Ophthalmology evaluated DMEK success when the donor cornea was from a person who had diabetes. One of the studies evaluated the 1-year success rates of the DMEK procedure when the corneal tissue was from a donor with or without diabetes. The authors found that the success rate was high regardless of diabetes status of the donor. The other study evaluated endothelial cell loss and corneal morphometry at 1 year, comparing donor corneal tissue with and without diabetes. It also found that diabetes status did not significantly affect endothelial cell density, endothelial cell loss, coefficient of variation in the cell area, or the percentage of hexagonal cells. These studies, according to the authors, “provide strong support for having no restrictions on the use of tissue from donors with diabetes for DMEK.”
• A retrospective, comparative clinical study looked at keratometric parameters (white-to-white, flattest keratometry [K1], steepest keratometry [K2], axis values for K1 and K2, and astigmatism and axis of astigmatism) with different devices (IOLMaster 500/700 [Zeiss], Pentacam HR/AXL [Oculus], and the VERION Image-Guided System [Alcon]). The authors reported no significant difference between the VERION and IOLMaster 500/700 in corneal astigmatism measurements, while there were statistically significant differences between these measurements with Pentacam HR/AXL and VERION. The astigmatic axis, K1 axis, and K2 axis showed high agreement among all the devices, according to the authors, but significant differences were seen in white-to-white, K1, and K2 measurements. The authors concluded that VERION is comparable with the measurements obtained by IOLMaster devices and Pentacam devices, allowing them “to be used interchangeably when planning astigmatism correction.” They advocated for “limiting the use to measurements in clinic with ‘green’ quality rating, [so] a high agreement for all variables between the VERION Image-Guided System and IOLMaster 500/700 can be achieved.” This paper is published in the Journal of Cataract & Refractive Surgery.

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Product news

• Virtual Vision Health added new features to its Virtual Eye platform, including additional language support, ocular motility and cover testing modules, and multi-exam integration that allows several tests to be conducted in a single session without the need to recalibrate or restart the device.
• Lumenis launched its latest SLT and YAG platform, Digital Duet 2.0.
• Optos unveiled Silverstone RGB, which offers “the broadest spectrum of retinal imaging capabilities available.” It is now available in direct markets.
• Haag-Streit launched its METIS 3D Digital Heads-Up Module, which includes the METIS 900 ophthalmic microscope system and integrated digital 3D visualization platform.

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