EyePoint Pharmaceuticals Completes Enrollment of Phase 3 Trials for Duravyu in Wet AMD

EyePoint Pharmaceuticals has successfully completed enrollment for pivotal Phase 3 clinical trials evaluating Duravyu, a sustained-release tyrosine kinase inhibitor (TKI) therapy for wet age-related macular degeneration (AMD).

LUCIA Trial Enrollment Concludes Ahead of Schedule

The company announced the completion of enrollment for the LUCIA trial, the second of two identical global Phase 3 noninferiority trials. LUCIA enrolled and randomized over 400 patients in just seven months, demonstrating what EyePoint described as “exceptional execution.” This follows the LUGANO trial, the first of the two studies, which completed enrollment in May 2025.

Safety Profile Consistent with Prior Trials

According to interim masked safety data, the safety profile observed in both LUGANO and LUCIA trials remains consistent with prior clinical experience. To date, Duravyu has been evaluated in more than 190 patients across four clinical studies, with no ocular or systemic serious adverse events related to the drug observed. An independent Data Safety Monitoring Committee (DSMC) has reviewed the data and recommended the continuation of the program as planned.

Regulatory Alignment and Study Design

The Phase 3 program, developed in collaboration with both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), builds on safety and efficacy data from the DAVIO 2 Phase 2 trial. All patients in the Phase 3 studies are randomized on Day 1 and immediately begin treatment, with primary efficacy and safety endpoints assessed at one year to support a potential New Drug Application (NDA) submission.

Anticipated Data and Clinical Impact

Topline data for the LUGANO trial is expected in mid-2026, with results from the LUCIA trial anticipated shortly afterward.

Dr. Jay S. Duker, President and CEO of EyePoint Pharmaceuticals, commented:
“With enrollment now complete for our phase 3 wet AMD program, well ahead of our expectations, we continue to demonstrate exceptional execution and our deep commitment to the retinal disease community. The industry-leading pace of our clinical program is a testament to the patient and physician enthusiasm for innovative, novel and more durable wet AMD treatments and Duravyu's compelling and differentiated profile. As we look ahead to anticipated topline data for LUGANO in mid-2026 and LUCIA to follow, 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.”

Expert Perspective on Clinical Relevance

Dr. Anat Loewenstein, Vice President of Ambulatory Services and Head of Retina at Tel Aviv Medical Center, and President of the European Society of Retina Specialists (EURETINA), highlighted the clinical utility of the program:
“With its use of a non-inferiority design and on-label aflibercept control, EyePoint’s phase 3 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.”

Trial Design and Dosing Strategy

LUGANO and LUCIA are randomized, double-masked, aflibercept-controlled, noninferiority trials assessing both treatment naïve and treatment-experienced patients with active wet AMD. In each trial, over 400 patients were randomized 1:1 to receive either Duravyu 2.7mg or on-label aflibercept.

Duravyu is administered via a standard intravitreal injection every six months, beginning at month two of the trial. This approach mirrors current FDA-approved anti-VEGF therapies in terms of administration but offers the potential benefit of reduced treatment frequency.

Primary and Secondary Endpoints

The primary endpoint of the Phase 3 trials is the average change in best corrected visual acuity (BCVA) at weeks 52 and 56 from baseline. Secondary endpoints include overall safety, reduction in treatment burden, percentage of eyes not requiring supplemental aflibercept injections, and anatomical outcomes as measured by optical coherence tomography (OCT).