EyePoint Pharmaceuticals Doses First Patient in Phase 3 LUGANO Trial of Duravyu for Wet AMD
Key Insights
EyePoint Pharmaceuticals has dosed the first patient in the Phase 3 LUGANO trial evaluating Duravyu (vorolanib intravitreal insert) for wet age-related macular degeneration (search) (AMD (search)).
The LUGANO trial, along with the planned LUCIA trial, will enroll approximately 400 patients, comparing Duravyu to aflibercept, with the primary endpoint being change in best-corrected visual acuity.
Duravyu, which utilizes the Durasert E technology to deliver the tyrosine kinase inhibitor vorolanib, aims to reduce treatment burden with a 6-month intravitreal injection schedule.
EyePoint Pharmaceuticals has announced the dosing of the first patient in its global Phase 3 LUGANO clinical trial, evaluating Duravyu (formerly EYP-1901) for the treatment of wet age-related macular degeneration (search) (AMD (search)). This marks a significant step in the development of a potentially paradigm-shifting treatment for this prevalent retinal disease. The company also plans to initiate a second Phase 3 trial, LUCIA, by the end of the year.
The LUGANO and LUCIA trials are designed as randomized, controlled studies, each enrolling approximately 400 patients with active wet AMD (search). Participants will be assigned to receive either a 2.7 mg dose of Duravyu or an on-label aflibercept control. The Duravyu treatment arm will involve intravitreal injections every six months, commencing in the second month of the trial.
Novel Mechanism of Action
Duravyu utilizes EyePoint’s Durasert E technology to deliver vorolanib, a selective tyrosine kinase inhibitor (TKI). Carl D. Regillo, MD, FACS, FASRS, chief of retina service at Wills Eye Hospital in Philadelphia and a clinical trial investigator, noted that vorolanib offers a new mechanistic approach by inhibiting all VEGF receptors (search). This pan-VEGF (search) receptor inhibition has the potential to maintain wet AMD (search) under control for at least six months, potentially reducing the treatment burden for patients.
The primary endpoint of both the LUGANO and LUCIA trials is the average change in best corrected visual acuity at weeks 52 and 56 compared to baseline. Secondary endpoints include safety, reduction in treatment burden, the percentage of eyes free of supplemental aflibercept injections, and OCT-measured anatomical outcomes.
Promising Phase 1 and 2 Results
Duravyu has already demonstrated promising results in earlier clinical trials. The Phase 1 DAVIO and Phase 2 DAVIO 2 trials showed clinically meaningful efficacy data and a favorable safety profile. Notably, in the DAVIO 2 trial, over 80% of patients with wet AMD (search) were free of supplemental anti-VEGF (search) injections or had received only one such injection in the six months following Duravyu treatment.
Jay S. Duker, MD, president and CEO of EyePoint Pharmaceuticals, emphasized the significance of this milestone, stating that it underscores the company’s leadership in sustained-release ocular drug delivery and commitment to developing innovative therapies for patients with serious retinal diseases. He added that the company has incorporated learnings from the DAVIO and DAVIO 2 trials to facilitate accelerated enrollment in the Phase 3 program.