EyePoint Pharmaceuticals(EYPT) - 2025 Q4 - Annual Results

Product Development - EyePoint's lead product candidate, DURAVYU™, is currently in Phase 3 trials for wet AMD and DME, with topline data expected in mid-2026[2] - Over 900 patients have been enrolled in the Phase 3 LUGANO and LUCIA trials within 7 months, making it one of the fastest enrolling wet AMD pivotal programs[4] - The Phase 3 wet AMD program has a primary endpoint of noninferiority in best corrected visual acuity (BCVA) at weeks 52 and 56, compared to aflibercept[6] - First patient dosing in the Phase 3 DME trials (COMO and CAPRI) is expected in Q1 2026, with each trial enrolling approximately 240 patients[6] - The independent Data Safety Monitoring Committee recommended the continuation of the Phase 3 program with no protocol modifications[6] Treatment Efficacy - DURAVYU demonstrated an 88% reduction in treatment burden six months after treatment, with over 80% of patients being supplement-free or requiring only one supplemental anti-VEGF injection[10] - DURAVYU's multi-mechanism of action includes a greater than 50% reduction in IL-6 activity, which is significant for treating wet AMD and DME[6] - DURAVYU is positioned as the only sustained release TKI in development for DME, addressing a significant need for new therapeutic options[3] Financial Overview - The company completed a public offering with gross proceeds of $172.5 million in October 2025, with approximately $300 million in cash and investments as of December 31, 2025[6] - EyePoint is preparing for an expeditious NDA filing and FDA review to deliver DURAVYU to patients as soon as possible[3]