EyePoint Completes Phase 3 Enrollment for DURAVYU™ in Wet AMD Treatment Trial

EyePoint Pharmaceuticals, Inc., a company dedicated to enhancing patient care for severe retinal diseases through innovative therapeutics, announced significant progress in its clinical trials for DURAVYU™, a treatment aimed at managing wet age-related macular degeneration (wet AMD). The company's Phase 3 clinical trial, named LUGANO, surpassed its enrollment target by enrolling and randomizing over 400 patients within a seven-month period. This achievement marks one of the fastest enrollments for a Phase 3 pivotal study in wet AMD.

LUGANO is part of a duo of pivotal trials evaluating the efficacy of DURAVYU, which is designed as a sustained-release tyrosine kinase inhibitor (TKI) intended for patients with wet AMD. Built upon the promising results of the DAVIO 2 Phase 2 clinical trial, which involved over 160 participants, the Phase 3 program aligns with U.S. Food and Drug Administration (FDA) guidelines. Its strategic design aims to maximize regulatory approval and commercial prospects. Patients enrolled in the LUGANO trial commence treatment on Day 1 and undergo a one-year evaluation of efficacy and safety, with topline data expected by mid-2026.

The swift enrollment rate reflects strong interest from both patients and physicians, highlighting the unmet need and potential market success of DURAVYU. Dr. Jay S. Duker, President and CEO of EyePoint, emphasized the commitment to introducing a new treatment option in the form of a sustained-release TKI. With optimistic timelines, the company anticipates releasing topline data from the LUGANO trial in mid-2026, followed by the LUCIA trial later that year.

Dr. Ramiro Ribeiro, Chief Medical Officer of EyePoint, noted the excitement surrounding DURAVYU among the retinal community, citing the trial’s design and established safety profile as key factors. The completion of LUGANO’s enrollment shifts focus to the LUCIA trial, expected to conclude enrollment by the third quarter of 2025. As enrollment extends internationally, certain LUGANO sites are set to transition to the LUCIA trial.

Principal Investigator Dr. Brittney Statler highlighted the LUGANO trial's collaborative engagement with the retinal community, emphasizing the opportunity to assess DURAVYU against aflibercept in a practical clinical setting. The trial's design allows all participants to receive active treatment, facilitating comprehensive evaluation of this potential next-generation therapy.

Both LUGANO and LUCIA are structured as randomized, double-masked, aflibercept-controlled trials. Each trial seeks to enroll approximately 400 patients globally, dividing participants between the DURAVYU 2.7mg treatment and an aflibercept control. These trials uniquely evaluate a six-month redosing schedule over two years, with DURAVYU delivered via standard intravitreal injection. The primary measure of success is the change in best corrected visual acuity (BCVA) at weeks 52 and 56 compared to baseline. Secondary considerations include safety, treatment burden reduction, and anatomical outcomes assessed through optical coherence tomography.

Wet AMD, a leading cause of vision impairment and blindness in individuals over fifty, results from abnormal blood vessel growth in the retina leading to fluid leakage and severe vision loss. Current treatments require frequent dosing, posing challenges for patient compliance and contributing to further vision deterioration.

DURAVYU™, formerly known as EYP-1901, is EyePoint’s investigational treatment for VEGF-mediated retinal diseases. Using the company's proprietary Durasert E™ technology, DURAVYU delivers vorolanib, a selective tyrosine kinase inhibitor, as a bioerodible insert. This approach promises neuroprotection and potential antifibrotic benefits. DURAVYU has demonstrated robust safety and efficacy in previous trials, significantly reducing treatment burden with most patients requiring minimal supplemental injections.

The company is also exploring DURAVYU for diabetic macular edema (DME). Recent Phase 2 results showed sustained improvement in vision and anatomy, supporting progression to Phase 3 trials. EyePoint continues to leverage its Durasert® technology, proven effective across multiple FDA-approved treatments, to advance its pipeline of retinal therapeutics.