EyePoint Completes Enrollment of Phase 3 Trials for Duravyu in Wet AMD
EyePoint Pharmaceuticals has completed enrollment of its phase 3 pivotal program with the full enrollment of the LUCIA trial, the second of two identical ongoing pivotal noninferiority trials evaluating Duravyu for the treatment of wet age-related macular degeneration (AMD). The first pivotal trial, LUGANO, completed enrollment in May 2025. The LUCIA trial has enrolled and randomized more than 400 patients in 7 months.
The company also announced that based on interim masked safety data, the safety profile observed in LUGANO and LUCIA is consistent with previous Duravyu clinical trials. Duravyu has been evaluated in over 190 patients across four clinical trials demonstrating a favorable safety and tolerability profile including no Duravyu related ocular or systemic serious adverse events observed. In parallel, an independent Data Safety Monitoring Committee (DSMC) convened and recommended continuation of the program as planned.
LUGANO and LUCIA are supported by the safety and efficacy data from the DAVIO 2 phase 2 clinical trial. The phase 3 pivotal program was developed in alignment with the FDA and European Medicines Agency (EMA). All patients are randomized on Day 1 and immediately begin treatment with a 1-year efficacy and safety endpoint to support an NDA filing. 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.
“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,” Jay S. Duker, MD, President and Chief Executive Officer of EyePoint, said in a company news release. “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.”
“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," said Anat Loewenstein, MD, MHA, Vice President Ambulatory Services, Head of Retina Tel Aviv Medical Center, President of European Society of Retina Specialists (EURetina) and member of EyePoint’s Scientific Advisory Board. "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."
LUGANO and LUCIA are randomized, double-masked, aflibercept controlled, noninferiority phase 3 trials assessing the efficacy and safety of Duravyu in patients with active wet AMD including treatment naïve and treatment experienced patients. Enrollment is complete in both trials with over 400 patients enrolled in each trial. Patients are randomized 1:1 to receive either Duravyu 2.7mg or an on-label aflibercept control.
The LUGANO and LUCIA trials are the only sustained release wet AMD pivotal phase 3 trials evaluating 6-month redosing in both trials over two-years. Patients in the DURAVYU 2.7mg treatment arm will receive an intravitreal dose of Duravyu every six months, starting at month two of the trial. Duravyu is delivered via a standard intravitreal injection in the physician's office, similar to current standard practice with FDA approved anti-VEGF treatments. The primary endpoint of the phase 3 pivotal trials is the average change in best corrected visual acuity (BCVA) at weeks 52 and 56 versus baseline. Secondary endpoints include safety, reduction in treatment burden, percentage of eyes free of supplemental aflibercept injections, and anatomical results as measured by optical coherence tomography (OCT).