One of the fastest enrolling phase III pivotal programs for wet AMD
EyePoint Pharmaceuticals (Watertown, MA) has completed enrollment of its phase III pivotal program with the full enrollment of the LUCIA trial, the second of two identical ongoing pivotal non-inferiority trials evaluating DURAVYU™ (vorolanib intravitreal insert, f/k/a EYP-1901) for the treatment of wet age-related macular degeneration (wet AMD). The first pivotal trial, LUGANO, completed enrollment in May 2025.
The LUCIA trial has enrolled and randomized over 400 patients in seven months making DURAVYU one of the fastest enrolling phase III pivotal programs in wet AMD. LUGANO and LUCIA are supported by the robust safety and efficacy data from the DAVIO 2 phase II clinical trial. With the completion of enrollment for LUCIA, topline data is anticipated to follow shortly after topline data for LUGANO, which is expected in mid-2026.
Anat Loewenstein, Head of Retina Tel Aviv Medical Center, President of European Society of Retina Specialists (EURetina) and member of EyePoint’s Scientific Advisory Board, commented: "The rapid enrollment of the LUCIA trial reflects its patient-centric design, DURAVYU’s excellent safety profile, and EyePoint’s ongoing engagement with the retinal community,” said “With its use of a non-inferiority design and on-label aflibercept control, EyePoint’s phase III program is designed to generate data that is relevant to clinical practitioners like myself. Additionally, the 6-month redosing schedule being evaluated would enable greater clinical flexibility and improved compliance for patients, representing a potential paradigm shift for the treatment of wet AMD.”
Jay S. Duker, President and Chief Executive Officer of EyePoint, added: “As we look ahead to anticipated topline data for LUGANO [and] LUCIA ... we remain focused on bringing the first sustained-release TKI for wet AMD to market and advancing our mission of delivering transformative treatment options for patients.”
EyePoint Pharmaceuticals (Watertown, MA) has completed enrollment of its phase III pivotal program with the full enrollment of the LUCIA trial, the second of two identical ongoing pivotal non-inferiority trials evaluating DURAVYU™ (vorolanib intravitreal insert, f/k/a EYP-1901) for the treatment of wet age-related macular degeneration (wet AMD). The first pivotal trial, LUGANO, completed enrollment in May 2025.
The LUCIA trial has enrolled and randomized over 400 patients in seven months making DURAVYU one of the fastest enrolling phase III pivotal programs in wet AMD. LUGANO and LUCIA are supported by the robust safety and efficacy data from the DAVIO 2 phase II clinical trial. With the completion of enrollment for LUCIA, topline data is anticipated to follow shortly after topline data for LUGANO, which is expected in mid-2026.
Anat Loewenstein, Head of Retina Tel Aviv Medical Center, President of European Society of Retina Specialists (EURetina) and member of EyePoint’s Scientific Advisory Board, commented: "The rapid enrollment of the LUCIA trial reflects its patient-centric design, DURAVYU’s excellent safety profile, and EyePoint’s ongoing engagement with the retinal community,” said “With its use of a non-inferiority design and on-label aflibercept control, EyePoint’s phase III program is designed to generate data that is relevant to clinical practitioners like myself. Additionally, the 6-month redosing schedule being evaluated would enable greater clinical flexibility and improved compliance for patients, representing a potential paradigm shift for the treatment of wet AMD.”
Jay S. Duker, President and Chief Executive Officer of EyePoint, added: “As we look ahead to anticipated topline data for LUGANO [and] LUCIA ... we remain focused on bringing the first sustained-release TKI for wet AMD to market and advancing our mission of delivering transformative treatment options for patients.”
