(RTTNews) - EyePoint Pharmaceuticals (EYPT), a clinical-stage biopharmaceutical company, on Tuesday announced the first patient has been dosed in its second global Phase 3 clinical trial of DURAVYU for the treatment of wet age-related macular degeneration, dubbed LUCIA.
The LUCIA trial is a pivotal Phase 3 study evaluating DURAVYU, an investigational sustained delivery therapy, that utilizes EyePoint's proprietary Durasert E technology to deliver vorolanib, a selective tyrosine kinase inhibitor. The treatment is designed for sustained intraocular delivery to address the high treatment burden associated with wet age-related macular degeneration. (wet AMD).
EyePoint's President and CEO, Dr. Jay S. Duker, expressed about this milestone, highlighting the enrollment in the first pivotal Phase 3 trial, the LUGANO trial, exceeded expectations. With two simultaneous Phase 3 trials, EyePoint aims to collect the most comprehensive clinical dataset of long-acting treatments in development for wet AMD.
The LUCIA and LUGANO trials are global, randomized, double-masked, aflibercept-controlled, non-inferiority studies assessing DURAVYU's efficacy and safety.
The trials are expected to enroll about 400 patients globally, with DURAVYU being administered every six months, starting at month two.
The primary endpoint is the average change in best-corrected visual acuity (BCVA) at weeks 52 and 56.
EyePoint also provided updates on its other ongoing studies. The Phase 2 VERONA trial for diabetic macular edema (DME) is progressing, with topline data expected in the first quarter 2025. The company expects to provide key data on both the LUGANO and LUCIA trials in 2026.
Dr. Ramiro Ribeiro, EyePoint's Chief Medical Officer, emphasized the importance of the LUCIA trial, noting that it includes both treatment-naive and previously treated wet AMD patients.
The trial also explores the re-dosing of DURAVYU every six months, which aligns with potential real-world treatment protocols.
EyePoint is also progressing with its other pipeline programs, including EYP-2301, a TIE-2 agonist designed to stabilize retinal blood vessels and improve vascular health. The company is leveraging its Durasert E technology, which has already been safely administered in thousands of patients through FDA-approved products, to optimize delivery of EYP-2301.
EYPT closed Tuesday's trading at $8.36, down 4.51%. In premarket trading today, the stock is up by 3.05% at $8.62.
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