EyePoint Provides Company Update and Anticipated Development Milestones for 2025

Core Insights - EyePoint Pharmaceuticals is advancing its lead product candidate, DURAVYU, with enrollment in Phase 3 clinical trials for wet AMD exceeding expectations, particularly with the LUGANO trial having one-third of its planned patients enrolled and the LUCIA trial ahead of schedule [1][2][3] - Full data from the Phase 2 VERONA clinical trial for diabetic macular edema (DME) is anticipated in the first quarter of 2025, with positive interim results already reported [1][8] - The company has appointed Dr. Reginald J. Sanders, a renowned retina specialist, to its Board of Directors, enhancing its leadership team [1][10] - EyePoint has a strong financial position with approximately $370 million in cash and investments as of December 31, 2024, providing a cash runway into 2027 [1][10] Clinical Trials and Data - The global Phase 3 trials, LUGANO and LUCIA, are designed to evaluate the efficacy, durability, and safety of DURAVYU, with topline data expected in 2026 [3][11] - DURAVYU's Phase 2 clinical trial (DAVIO 2) demonstrated a treatment burden reduction of approximately 88% six months post-treatment, with over 80% of patients being supplement-free or requiring only one supplemental anti-VEGF injection [7][10] - Interim data from the Phase 2 VERONA trial showed that DURAVYU 2.7mg significantly improved patients with active DME, with a central subfield thickness (CST) improvement of 68.1 microns and a best-corrected visual acuity (BCVA) gain of +8.9 letters compared to baseline [3][8] Manufacturing and Infrastructure - EyePoint opened a new 40,000 square-foot manufacturing facility in Northbridge, MA, in fall 2024, which is designed to meet FDA and EMA standards and support global manufacturing for DURAVYU [2][10] - The facility enhances EyePoint's manufacturing capabilities and is strategically positioned to support the company's growth and pipeline expansion [10] Future Milestones - EyePoint will present at the 43rd Annual J.P. Morgan Healthcare Conference on January 14, 2025, to provide updates on clinical and regulatory progress [1][10] - The company is preparing for interactions with the FDA and EMA regarding the Phase 3 plans following the full topline data from the VERONA trial [10][11]