EyePoint Pharmaceuticals reported a third positive DSMC review for its Phase 3 DURAVYU program in wet AMD, with LUGANO and LUCIA continuing unchanged ahead of expected mid-2026 topline data.
Written By: Fariha Sameen, PharmD
Reviewed By: Pharmacally Editorial Team
EyePoint Pharmaceuticals a clinical-stage biopharmaceutical company developing therapies for serious retinal diseases, announced a key milestone in its pivotal Phase 3 program evaluating DURAVYU™ (vorolanib intravitreal insert) for wet age-related macular degeneration (wet AMD).
The independent Data Safety Monitoring Committee (DSMC) completed its third scheduled review of the Phase 3 program and recommended that both the LUGANO and LUCIA studies continue as planned without protocol modifications. This was the final anticipated DSMC meeting before topline data release.
Interim masked safety data from the ongoing Phase 3 studies remained consistent with the favorable safety profile observed in more than 190 patients across four completed clinical trials, including DAVIO, DAVIO 2, and VERONA.
Dr. Ramiro Ribeiro, Chief Medical Officer of EyePoint Pharmaceuticals, said three consecutive positive DSMC recommendations reinforce confidence in DURAVYU’s safety profile and its potential to become a first- and best-in-class therapy for wet AMD.
The global Phase 3 wet AMD program includes two identical randomized, double-masked, aflibercept-controlled, non-inferiority trials, LUGANO (NCT06668064) and LUCIA (NCT06683742). The studies enrolled both treatment-naïve and treatment-experienced patients with active wet AMD and are currently the only sustained-release pivotal wet AMD studies evaluating six-month redosing over two years.
Enrollment has been completed across both trials with more than 900 patients randomized 1:1 to receive either DURAVYU 2.7mg every six months or on-label aflibercept. As of May 2, 2026, all active patients in the DURAVYU arm reached the Week 32 visit and received their second dose, while more than 35% have already received their third planned dose at Week 56.
DURAVYU is administered through a standard intravitreal injection and is designed using EyePoint’s Durasert E™ bioerodible delivery technology to provide sustained drug release for at least six months.
The primary endpoint of the Phase 3 studies is non-inferiority in the average change in best corrected visual acuity (BCVA) at Weeks 52 and 56 versus baseline. Secondary endpoints include safety, reduction in treatment burden, the percentage of eyes free from supplemental aflibercept injections, and anatomical outcomes measured by optical coherence tomography (OCT).
Topline data from the LUGANO trial is expected in mid-2026, followed shortly thereafter by results from LUCIA. EyePoint is also enrolling patients in the Phase 3 diabetic macular edema (DME) studies, COMO and CAPRI, with topline data expected in the second half of 2027.
About the Writer
Fariha Sameen, PharmD (LinkedIn), is a clinical pharmacy professional with hands-on experience in patient counselling, medication review, therapeutic monitoring, and clinical documentation across multiple departments. She has experience identifying and assessing drug-related problems and supporting medication safety practices. Her interests include pharmacovigilance, ADR reporting, clinical research, and medical writing focused on clear, evidence-based communication.