EyePoint Completes Enrollment in Phase 3 LUGANO Trial of Duravyu for Wet AMD

EyePoint Pharmaceuticals has successfully completed patient enrollment in its Phase 3 LUGANO trial, a pivotal study evaluating Duravyu for the treatment of wet age-related macular degeneration (AMD). Over 400 patients have been enrolled and randomized across trial sites in just seven months, marking a significant milestone for the company’s late-stage development program.

LUGANO: A Key Component of the Phase 3 Duravyu Program

LUGANO is the first of two pivotal, noninferiority trials under the Phase 3 program evaluating the safety and efficacy of Duravyu in wet AMD. The program is built upon the foundation of the DAVIO 2 Phase 2 clinical trial, which included more than 160 patients. Developed in collaboration with the U.S. Food and Drug Administration (FDA), the Phase 3 program is designed to reflect real-world treatment dynamics.

All patients in LUGANO were randomized on Day 1 and initiated treatment immediately, with primary efficacy and safety endpoints assessed over a one-year period. With enrollment now complete, topline results from the LUGANO trial are expected by mid-2026.

LUGANO Trial Completes Enrollment Ahead of Schedule

“The rapid enrollment of the Phase 3 LUGANO trial is a testament to the significant patient and physician enthusiasm for our Phase 3 program and underscores the tremendous patient need and commercial market potential for Duravyu,” said Jay S. Duker, MD, President and CEO of EyePoint Pharmaceuticals.

“We are committed to bringing the first sustained-release tyrosine kinase inhibitor (TKI) to market for patients and physicians in need of a new treatment option for wet AMD. With both pivotal trials continuing to exceed our timelines, we now expect topline data for the LUGANO trial in mid-2026, with LUCIA to follow in the second half of 2026.”

Trial Design Aligned with Clinical Treatment Settings

Dr. Brittney Statler, Principal Investigator in the LUGANO clinical trial and Medical Retina Specialist at Panorama Eyecare, highlighted the clinical design’s advantages: “One of the many compelling elements of this program is the fact that all patients receive active treatment with either aflibercept or Duravyu, enabling us to effectively evaluate this potential next-generation treatment for wet AMD in a real-world clinical practice setting.”

Study Overview: LUGANO and LUCIA Trials

Both LUGANO and LUCIA are randomized, double-masked, aflibercept-controlled, noninferiority Phase 3 trials designed to assess the efficacy and safety of Duravyu 2.7 mg in patients with active wet AMD. This includes both treatment-naïve and treatment-experienced individuals. Each trial aims to enroll approximately 400 patients.

EyePoint noted that LUGANO and LUCIA are currently the only sustained-release pivotal Phase 3 trials evaluating six-month redosing intervals over a two-year duration. Patients receiving Duravyu will be administered intravitreal injections every six months, beginning at Month 2 of the study. The delivery method follows the standard practice used with existing anti-VEGF therapies.

Efficacy and Safety Endpoints

The primary endpoint for both Phase 3 trials is the average change in best corrected visual acuity (BCVA) at weeks 52 and 56 compared to baseline. Secondary endpoints include:

       • Safety evaluations

       • Reduction in treatment burden

       • Percentage of eyes free from supplemental aflibercept injections

       • Anatomical outcomes assessed via optical coherence tomography (OCT)