EyePoint Teases Mid-2026 DURAVYU Readout, Initiates 240-Patient DME Phase III
EyePoint has fully enrolled over 900 patients in its LUGANO and LUCIA Phase III wet AMD trials, with LUGANO results due mid-2026 and a –4.5-letter non-inferiority margin versus on-label aflibercept. The company initiated its 240-patient COMO and CAPRI DME program and ended 2025 with $300M cash runway to Q4 2027.
1. Phase III Wet AMD Trials and Timeline
EyePoint has completed enrollment of over 900 patients across its LUGANO and LUCIA Phase III wet age-related macular degeneration trials, each evaluating a six-month dosing interval of a vorolanib insert. The company targets mid-2026 LUGANO data with a primary non-inferiority endpoint of –4.5 letters versus on-label aflibercept.
2. Safety Profile and Supplementation Criteria
Prior to Phase III, 190 patients in four trials experienced no serious ocular or systemic adverse events. Data safety monitoring committees have reviewed unmasked safety data twice and recommended no protocol changes. Supplementation in Phase III is triggered by a five-letter vision loss with at least 75 microns of fluid or hemorrhage adjudicated by key opinion leaders.
3. Phase III DME Program Initiation
EyePoint launched its 240-patient COMO and CAPRI Phase III diabetic macular edema trials in Q4 2025 with its CRO, expects first patient dosing this quarter, and projects enrollment in roughly six months. The trials leverage vorolanib’s dual anti-VEGF and JAK1-mediated IL-6 blockade in a six-month bio-erodible intravitreal insert, with data anticipated by end-2027.
4. Manufacturing Readiness and Financial Runway
The Northbridge, Massachusetts facility is operational and advancing to meet FDA chemistry, manufacturing, and controls requirements ahead of potential NDA submission. EyePoint ended 2025 with $300 million in cash, funding both wet AMD and DME pivotal programs, manufacturing scale-up, and U.S. self-commercialization through Q4 2027 with a planned 70-rep sales force.