EyePoint Pharmaceuticals has enrolled and randomized over 400 patients in the phase 3 LUGANO pivotal trial of Duravyu for the treatment of wet age-related macular degeneration (wet AMD), exceeding its enrollment target. The seven-month enrollment for LUGANO represents one of the fastest enrolling phase 3 pivotal trials for wet AMD to date, the company said in a press release. 

LUGANO is the first of 2 pivotal non-inferiority trials underway in the phase 3 program of Duravyu for the treatment of wet AMD. Supported by the DAVIO 2 phase 2 clinical trial in more than 160 patients, the phase 3 pivotal program was developed in direct alignment with the US Food and Drug Administration (FDA), follows recognized industry best practices, and is strategically designed to enhance the potential for regulatory and commercial success. All patients are randomized on Day 1 and immediately begin treatment with a one-year efficacy and safety endpoint. With the completion of enrollment for LUGANO, topline data is anticipated in mid-2026, the company said.

LUGANO and LUCIA are randomized, double-masked, aflibercept controlled, non-inferiority phase 3 trials assessing the efficacy and safety of Duravyu in patients with active wet AMD including treatment naïve and treatment experienced patients. The LUGANO trial has enrolled and randomized over 400 patients, and the LUCIA trial is also designed to enroll approximately 400 patients globally who will be randomly assigned to Duravyu 2.7 mg or an on-label aflibercept control.

According to the company, the LUGANO and LUCIA trials are the only sustained release wet AMD pivotal phase 3 trials evaluating 6-month redosing in both trials over 2-years. Patients in the Duravyu 2.7 mg treatment arm will receive an intravitreal dose of Duravyu every 6 months, starting at month 2 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 vs 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). More information about the trial is available at www.clinicaltrials.gov (LUGANO identifier: NCT06668064; LUCIA identifier: NCT06683742).