DURAVYU Phase 3 Updates: Wet AMD Readouts and DME Dosing Timelines

EyePoint reported that DURAVYU Phase 3 topline data in wet age-related macular degeneration (wet AMD) are anticipated in mid-2026 for LUGANO, with LUCIA expected shortly after. The update described LUGANO and LUCIA as pivotal Phase 3 trials in wet AMD that remain on track for readout beginning in mid-2026.

For wet AMD, the company described LUGANO and LUCIA as identical Phase 3 trials evaluating DURAVYU (vorolanib intravitreal insert) and reported that over 900 patients were enrolled. The release characterized both trials as following a non-inferiority pathway and noted a six-month re-dosing schedule. It also specified an on-label aflibercept control arm as part of the Phase 3 design, which the company framed as aligning the wet AMD program with an established comparative framework.

On program oversight, EyePoint reported that the independent Data Safety Monitoring Committee (DSMC) completed its second scheduled review of the wet AMD Phase 3 program and recommended continuation as planned, with no protocol modifications. Separately, the company referenced an interim masked safety data cut through September 29, 2025, and stated that the safety profile observed in LUGANO and LUCIA remained consistent with favorable safety observed in previous DURAVYU clinical trials.

In diabetic macular edema (DME), the company reported that first patients have been dosed in the Phase 3 COMO and CAPRI trials evaluating DURAVYU for DME. EyePoint described the pivotal DME program as following a non-inferiority pathway with an on-label aflibercept control arm and DURAVYU re-dosing every six months. The release also outlined an anticipated rapid enrollment of approximately 240 patients in each of COMO and CAPRI and stated an expectation for topline data in the second half of 2027. In the company’s framing, these points marked the transition of the DME program into active Phase 3 execution with a defined reporting window.

Key Takeaways:

• The company reported wet AMD Phase 3 readouts beginning in 2026, with two identical trials (LUGANO and LUCIA) described as using a six-month re-dosing schedule and an on-label aflibercept control arm.
• EyePoint stated the DSMC recommended continuing the wet AMD Phase 3 program without protocol modifications and referenced an interim masked safety cut dated September 29, 2025.
• For DME, the company reported first patient dosing in COMO and CAPRI and described a topline data timing window in 2027 for the pivotal program.