EyePoint Pharmaceuticals Doses First Patient in Second Phase 3 LUCIA Trial of Duravyu for Wet AMD

EyePoint Pharmaceuticals has successfully dosed the first patient in the LUCIA trial, marking the start of the company’s second global Phase 3 clinical study for Duravyu (formerly EYP-1901), an investigational sustained-release therapy for wet age-related macular degeneration (wet AMD).

Duravyu: A Novel Approach to Wet AMD Treatment

Duravyu utilizes EyePoint’s Durasert E technology, a proprietary sustained-release platform that delivers vorolanib, a selective tyrosine kinase inhibitor (TKI). Key features include:

       • Sustained intraocular drug release for long-term treatment.

       • Pan-VEGF receptor inhibition, targeting all VEGF receptors.

       • Potential neuroprotective and antifibrotic benefits, as demonstrated in preclinical models.

       • Simplified logistics with room temperature storage and administration via a standard intravitreal injection.

This innovative delivery system addresses the high treatment burden of frequent injections, which often leads to under-treatment and vision loss in wet AMD patients.

Insights from the LUCIA Trial

The LUCIA trial is designed to evaluate the safety, efficacy, and dosing flexibility of Duravyu. Adam Gerstenblith, MD, principal investigator and vitreoretinal surgeon, highlighted the significance of this study:
“This trial includes both treatment-naïve and previously treated wet AMD patients, with re-dosing every 6 months. It aligns well with how we envision using Duravyu in clinical practice.”

The trial is part of EyePoint’s broader Phase 3 pivotal program, which includes the LUGANO trial.

Key Details of the LUGANO and LUCIA Trials

Both trials are global, double-masked, randomized studies comparing Duravyu (2.7 mg) to aflibercept, an FDA-approved anti-VEGF treatment.  

       • Enrollment Goal: Approximately 400 patients per trial worldwide.

       • Primary Endpoint: Average change in best corrected visual acuity (BCVA) at weeks 52 and 56 from baseline.

       • Secondary Endpoints:

               - Reduction in treatment burden.

               - Percentage of eyes free of supplemental aflibercept injections.

               - Anatomical outcomes via optical coherence tomography (OCT).

Patients in the Duravyu treatment arm receive an intravitreal injection every 6 months, beginning 2 months into the trial.

Jay S. Duker, MD, President and CEO of EyePoint, emphasized the enthusiasm surrounding Duravyu:
“We are encouraged by the strong interest from physicians and patients, with enrollment in the LUGANO trial exceeding expectations.”

Potential Impact on Wet AMD Treatment

According to Ramiro Ribeiro, MD, PhD, Chief Medical Officer of EyePoint:
“The LUCIA and LUGANO trials are the first Phase 3 pivotal programs for sustained-release wet AMD therapies evaluating re-dosing in both trials. The data will provide valuable insights into the real-world application of Duravyu.”

Duravyu offers several potential advantages over current treatments:

       • Zero-order kinetics: Consistent drug release for up to 9 months.

       • Reduction in treatment burden: Long intervals between doses improve patient adherence.

       • Targeted delivery: Minimizes systemic exposure and adverse effects.

Beyond Wet AMD: The Future of Duravyu

Duravyu is also being studied in the VERONA Phase 2 trial for diabetic macular edema (DME), with topline results anticipated in Q1 2025.

This comprehensive clinical program underscores EyePoint’s commitment to addressing unmet needs in VEGF-mediated retinal diseases, offering hope for more durable and effective treatments.

Duravyu has the potential to redefine treatment paradigms, significantly improving outcomes for patients with wet AMD and other retinal conditions.