EyePoint Announces First Patient Dosed in Phase 3 LUCIA Trial of Duravyu for Wet AMD
EyePoint Pharmaceuticals announced that the first patient has been dosed in the LUCIA trial. This is the second global phase 3 clinical trial evaluating Duravyu (formerly EYP-1901), a sustained-delivery therapy for treating wet age-related macular degeneration (AMD).
Duravyu is an investigational therapy that uses a proprietary bioerodible Durasert E platform to deliver vorolanib, a selective tyrosine kinase inhibitor, directly to the eye. The treatment is designed to reduce the burden of frequent injections for patients with wet AMD.
“Dosing the first patient in the LUCIA trial marks a significant milestone for EyePoint and demonstrates our commitment to execution,” Jay S. Duker, MD, President and CEO of EyePoint, said in a company news release. “With enrollment in our first pivotal trial, the LUGANO trial, exceeding expectations, we are encouraged by the enthusiasm for Duravyu. Having two simultaneous phase 3 trials underscores our position as a leader in sustained-release ocular therapies.”
Dr. Duker noted that the robust clinical dataset from these trials positions the company well to address a major unmet need in wet AMD treatment.
“The phase 3 pivotal program is the first and only sustained release wet AMD pivotal program evaluating re-dosing in both trials. Following a typical noninferiority approval pathway, the LUGANO and LUCIA trials will provide data on the efficacy, durability, safety and dosing flexibility of treatment with DURAVYU and have the potential to provide the retina community valuable insights on how Duravyu could be used in ‘real-world’ practice," said Ramiro Ribeiro, MD, PhD, Chief Medical Officer of EyePoint. "With over 240 global sites already committed across both Phase 3 trials and exceptional patient and investigator enthusiasm, we are confident we can rapidly enroll patients in the Phase 3 pivotal trials.”
Adam Gerstenblith, MD, principal investigator in the LUCIA trial and vitreoretinal surgeon at Mid Atlantic Retina Specialists, said the design of the LUCIA trial includes both treatment naïve and previously treated wet AMD patients, as well as re-dosing of Duravyu every 6 months, which aligns well with how retina specialists would approach potential treatment using Duravyu in clinical practice.
The LUGANO and LUCIA trials are global, randomized, double-masked studies comparing Duravyu to aflibercept, a current standard of care. Each trial aims to enroll approximately 400 patients. Participants in the Duravyu arm will receive injections every 6 months, starting at month 2, while aflibercept is administered according to its approved dosing regimen.
The primary endpoint measures the average change in best-corrected visual acuity (BCVA) at weeks 52 and 56 compared to baseline. Secondary endpoints include safety, treatment burden reduction, supplemental injection rates, and anatomical improvements via optical coherence tomography (OCT).