EyePoint Announces Pivotal Phase 3 Program Initiation for DURAVYU™ in Diabetic Macular Edema

Core Insights - EyePoint Pharmaceuticals is advancing DURAVYU (vorolanib intravitreal insert) into Phase 3 trials for diabetic macular edema (DME), with first patient dosing expected in Q1 2026 [1][14] - New preclinical data indicates that vorolanib inhibits both VEGF-mediated vascular permeability and IL-6 mediated inflammation, which are significant factors in wet AMD and DME [1][4] - DURAVYU is positioned as a potential multi-mechanism treatment option, addressing both inflammation and vascular leakage, which are critical in managing DME [2][5] Company Overview - EyePoint Pharmaceuticals is a clinical-stage biopharmaceutical company focused on innovative therapeutics for serious retinal diseases [15] - The lead product candidate, DURAVYU, utilizes next-generation Durasert E technology for sustained drug delivery [10][15] - Vorolanib, the active ingredient in DURAVYU, is a selective tyrosine kinase inhibitor targeting both VEGF and IL-6 pathways [11][12] Clinical Development - The Phase 3 program for DME consists of two identical non-inferiority trials, enrolling approximately 240 patients each, comparing DURAVYU to aflibercept [6][12] - The primary endpoint of the trials is the change in best corrected visual acuity (BCVA) at weeks 52 and 56 [6] - Previous Phase 2 trials demonstrated significant treatment burden reduction, with approximately 88% fewer injections needed after six months [12] Market Need - There is a significant unmet need for effective treatments for DME, as up to two-thirds of patients remain active despite anti-VEGF therapies [5][8] - The multifactorial nature of DME necessitates treatment options that address both VEGF and inflammatory pathways [5][8] - DME is a leading cause of vision loss in diabetic patients, affecting approximately 28 million people globally [9] Future Outlook - The retinal community is optimistic about DURAVYU's potential to improve patient outcomes, particularly given its favorable safety profile and dosing intervals compared to existing therapies [8][14] - EyePoint plans to present preclinical data on JAK/IL-6 inhibition at the Eyecelerator meeting at AAO 2025 [8]