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

EyePoint Pharmaceuticals announced it 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 (AMD). Enrollment took 7 months.

LUGANO is the first of two pivotal noninferiority 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 over 160 patients, the phase 3 pivotal program was developed in alignment with the FDA. All patients are randomized on Day 1 and immediately begin treatment with a 1-year efficacy and safety endpoint. With the completion of enrollment for LUGANO, topline data is anticipated in mid-2026.

“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,” Jay S. Duker, MD, President and Chief Executive Officer of EyePoint, said in a company news release. “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.”

“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," said Brittney Statler, MD, Principal Investigator in the LUGANO clinical trial and Medical Retina Specialist at Panorama Eyecare.

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. 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 2.7mg or an on-label aflibercept control. The LUGANO and LUCIA trials are the only sustained release wet AMD pivotal thase 3 trials evaluating 6-month redosing in both trials over 2 years, according to EyePoint. Patients in the Duravyu 2.7mg 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 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).

More information about the trial is available at www.clinicaltrials.gov (LUGANO identifier: NCT06668064; LUCIA identifier: NCT06683742).