EyePoint completes enrollment for phase 3 LUGANO trial of DURAVYU in wet AMD

(Image Credit: AdobeStock/Алина Бузунова)

EyePoint Pharmaceuticals recently announced the enrollment and randomization of its phase 3 LUGANO trial (NCT06668064) of DURAVYU for the treatment of wet age-related macular degeneration (wet AMD). EyePoint enrolled more than 400 patients in 7 months, making LUGANO one of the fastest enrolling phase 3 pivotal trials for wet AMD to date.

The phase 3 pivotal trial program for DURAVYU was developed with the US Food and Drug Administration (FDA), following recognized industry best practices, and strategically designed to enhance the potential for regulatory and commercial success, the company said.

“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 DURAVUY,” said Jay S. Duker, MD, president and CEO of EyePoint.

“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.”

Supported by the phase 2 DAVIO 2 clinical trial data, LUGANO is the first of 2 pivotal noninferiority trials underway in the phase 3 program of DURAVYU for the treatment of wet AMD, according to a press release.

Both LUGANO and LUCIA (NCT06683742) are randomized, double-masked, aflibercept-controlled, noninferiority phase 3 trials to assess the safety and efficacy of DURAVYU in patients with wet AMD—including treatment-naive and treatment-experienced patients. They are the only pivotal phase 3 trials in wet AMD with a sustained-release agent to evaluate 6-month redosing in both trials over 2 years.

LUGANO has enrolled more than 400 patients, and LUCIA is designed to enroll approximately 400 patients globally. Patients will be randomly assigned into 2 groups and receive either DURAVYU 2.7 mg or an on-label aflibercept control. Patients in the treatment arm will receive a DURAVYU 2.7-mg intravitreal injection every 6 months beginning at month 2 of the trial.

The trial's primary end point is the average change in best corrected visual acuity (BCVA) at weeks 52 and 56 compared with baseline. The secondary end points include safety, reduction in treatment burden, percentage of eyes free of supplemental aflibercept injections, and anatomical results as measured by optical coherence tomography (OCT).

Duker said that topline data for the LUGANO trial are expected in mid-2026, followed by LUCIA's in the second half of 2026, as both trials are continuing to exceed the company’s anticipated timelines.

Reference

1. EyePoint completes enrollment in pivotal phase 3 LUGANO trial of DURAVYU for treatment of wet age-related macular degeneration. News release. EyePoint Pharmaceuticals, Inc. May 27, 2025. Accessed May 27, 2025. https://investors.eyepointpharma.com/news-releases/news-release-details/eyepoint-completes-enrollment-pivotal-phase-3-lugano-trial ‌