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EyePoint Announces First Patients Dosed in Both Global Phase 3 Clinical Trials of DURAVYU™ for the Treatment of Diabetic Macular Edema
– Active Phase 3 programs for DURAVYU in wet AMD and DME, the two largest multi-billion-dollar retinal disease markets – – Topline data for DURAVYU in DME
About this update from Eyepoint, Inc.
[{"type":"text","content":"– Active Phase 3 programs for DURAVYU in wet AMD and DME, the two largest multi-billion-dollar retinal disease markets – – Topline data for DURAVYU in DME anticipated in 2H 2027 – WATERTOWN, Mass., March 02, 2026 (GLOBE NEWSWIRE) -- EyePoint, Inc. (Nasdaq: EYPT), a company committed to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases, today announced the first patient dosed in both Phase 3 COMO and CAPRI global clinical trials of DURAVYU™ (vorolanib intravitreal insert) for the treatment of diabetic macular edema (DME). DURAVYU is an investigational sustained delivery therapy delivering vorolanib, a selective tyrosine kinase inhibitor (TKI) that brings a novel, multi-mechanism of action inhibiting VEGF-mediated vascular permeability, PDGF, and IL-6 mediated inflammation to the potential treatment of DME. “Dosing of the first patients in our two pivotal DME trials represents a significant milestone for EyePoint and DURAVYU – the only TKI in Phase 3 clinical trials for DME – and solidifies our leadership in sustained-release ocular drug delivery,” said Ramiro Ribeiro, M.D., Ph.D., Chief Medical Officer of EyePoint. “Informed by the positive Phase 2 VERONA DME results, the efficient trial design of COMO and CAPRI follow an established non-inferiority regulatory pathway leveraging the relationships and infrastructure of our exceptionally well-executed pivotal wet AMD program. Together, these trials are designed to position DURAVYU with the potential to be the first-in-class and best-in-class TKI for DME, a disease that continues to cause vision loss and significant treatment burden despite available anti-VEGF therapies.” “There is a clear need for more durable and differentiated treatment options for patients with DME,” said David Eichenbaum, M.D., Principal Investigator in the CAPRI clinical trial and Director of Research for Retina Vitreous Associates. “The current standard of care is overly burdensome for a largely working-age population, and existing therapies do not fully address the underlying disease, as up to two-thirds of DME patients still have active disease after anti-VEGF loading. DURAVYU’s multi-MOA uniquely targets inflammation through inhibition of IL-6/JAK1 signaling while also reducing vascular leakage through blocking of all VEGF receptors, as in...