EyePoint Announces Positive Six-Month Results for the Phase 2 VERONA Clinical Trial of DURAVYU™ for Diabetic Macular Edema Meeting Primary and Secondary Endpoints

Core Insights - EyePoint Pharmaceuticals announced positive six-month results from the Phase 2 VERONA clinical trial for DURAVYU, achieving its primary endpoint of extended time to first supplemental injection compared to aflibercept control [1][3] - DURAVYU 2.7mg showed a significant improvement in best corrected visual acuity (BCVA) with a gain of +7.1 letters and a reduction in central subfield thickness (CST) by 76 microns, alongside a two-thirds reduction in treatment burden [1][2][3] - The safety profile of DURAVYU remains favorable, with no ocular or systemic serious adverse events reported [1][3] Company Overview - EyePoint Pharmaceuticals is focused on developing innovative therapeutics for serious retinal diseases, utilizing its proprietary bioerodible Durasert E™ technology for sustained intraocular drug delivery [11] - The company plans to initiate a Phase 3 non-inferiority pivotal program for DURAVYU in diabetic macular edema (DME) by the end of 2025, following positive Phase 2 results [1][10] Clinical Trial Details - The Phase 2 VERONA trial involved 27 patients and compared two doses of DURAVYU (1.34mg and 2.7mg) against aflibercept control, with the primary endpoint being the time to first supplemental injection over 24 weeks [4] - Key secondary endpoints included changes in BCVA, CST, and diabetic retinopathy severity scale (DRSS) [4] Market Context - DME is a leading cause of vision loss among working-age adults, with a significant need for more durable treatment options as the prevalence of diabetes increases [6][4] - The number of diabetic retinopathy patients is projected to reach 16 million by 2050, highlighting the growing market for effective treatments [4] Future Outlook - EyePoint anticipates presenting interim data at an upcoming medical meeting and is preparing for discussions with the FDA regarding the Phase 3 trial initiation [5][2] - The company is also conducting ongoing pivotal trials in wet age-related macular degeneration (wet AMD), with results expected in 2026 [10][11]