EyePoint Reports Fourth Quarter and Full-Year 2025 Financial Results and Highlights Recent Corporate Developments

Core Insights - EyePoint, Inc. is advancing its pivotal Phase 3 trials for DURAVYU in wet age-related macular degeneration (AMD) and diabetic macular edema (DME), with data readouts expected to begin in mid-2026 [1][2] - The company has appointed Michael Campbell as Chief Commercial Officer to lead the launch strategy for DURAVYU [1] - As of December 31, 2025, EyePoint reported over $300 million in cash and investments, providing financial stability into Q4 2027 [1][12] Clinical Development - DURAVYU is currently in two identical Phase 3 trials, LUGANO and LUCIA, for wet AMD, with over 900 patients enrolled [4] - The trials are designed to follow a non-inferiority pathway with an on-label aflibercept control arm and six-month re-dosing [4] - Interim safety data from the trials has shown a consistent favorable safety profile [4] - The first patients have been dosed in the COMO and CAPRI Phase 3 trials for DME, with rapid enrollment expected [4] Financial Performance - For Q4 2025, total net revenue was $0.6 million, a significant decrease from $11.6 million in Q4 2024 [6] - Net product revenue for Q4 2025 was $0.3 million, down from $0.8 million in the same period of 2024 [6] - Total net revenue for the full year 2025 was $31.4 million, compared to $43.3 million in 2024 [9] - Operating expenses for Q4 2025 totaled $71.0 million, up from $56.8 million in the prior year, primarily due to ongoing Phase 3 trials [8][11] Corporate Developments - EyePoint has expanded its intellectual property protection for DURAVYU with a new U.S. patent expected to extend coverage into 2043 [10] - The company completed manufacturing of registration batches for DURAVYU, which will support the New Drug Application (NDA) filing [10] - An underwritten public offering in October 2025 raised gross proceeds of $172.5 million [10]