EyePoint doses first patient in second global Phase 3 LUCIA clinical trial of Duravyu for the treatment of wet AMD

(Image credit: Adobe Stock/JP STUDIO LAB)

EyePoint Pharmaceuticals Inc. has announced the successful dosing of the first patient in the LUCIA trial, marking the initiation of the company’s second global Phase 3 clinical study of Duravyu (formerly EYP-1901) for the treatment of wet age-related macular degeneration (wet AMD).

Duravyu is an investigational sustained-release therapy that delivers patent-protected vorolanib, a selective tyrosine kinase inhibitor, through a proprietary bioerodible Durasert E formulation. This innovative delivery system is designed for sustained intraocular release, offering the potential for long-term management of wet AMD.¹

Adam Gerstenblith, MD, principal investigator in the LUCIA clinical trial and vitreoretinal surgeon at Mid Atlantic Retina Specialists, pointed out that patients diagnosed with wet AMD typically require lifelong treatment with frequent intravitreal injections to preserve their vision.

“This high treatment burden often results in under-treatment and irreversible vision loss,” Gerstenblith said in a statement. “The Phase 3 LUCIA trial is an important step forward in our pursuit of more durable treatments that are safe and effective. Moreover, 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 we would approach potential treatment using Duravyu in clinical practice.”

Jay S. Duker, MD, president and CEO of EyePoint, said dosing the first patient in the company’s second global Phase 3 clinical trial, the LUCIA (NCT06683742) trial, marks a milestone.

“We are encouraged by the robust physician and patient interest in Duravyu with enrollment in our first pivotal trial, the LUGANO (NCT06668064) trial, exceeding our expectations,” he said in the news release.

Ramiro Ribeiro, MD, PhD, chief medical officer of EyePoint, noted that 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 non-inferiority 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,” he said. “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.”

The company noted its LUGANO and LUCIA trials are global, randomly assigned, double-masked, Phase 3 studies comparing Duravyu to aflibercept, designed to assess the efficacy and safety of Duravyu in patients with active wet AMD, including both previously treated and treatment-naïve individuals. The company added that each trial aims to enroll approximately 400 patients worldwide, who will be randomly assigned to receive either a 2.7 mg dose of Duravyu or an on-label dose of aflibercept. These are the only Phase 3 pivotal trials for sustained-release wet AMD that evaluate re-dosing in both trials.1

Moreover, the company noted that patients in the Duravyu treatment arm will receive an intravitreal injection of Duravyu every 6 months, starting at month 2 of the trial. Duravyu is delivered via a standard intravitreal injection in the physician’s office, similar to current standard practice with FDA-approved anti-VEGF treatments. The primary endpoint of the Phase 3 pivotal trials is the average change in best corrected visual acuity (BCVA) at weeks 52 and 56 versus baseline. Secondary endpoints include safety, reduction in treatment burden, percentage of eyes free of supplemental aflibercept injections, and anatomical results as measured by optical coherence tomography (OCT).

Duravyu, previously known as EYP-1901, is being developed as a potentially groundbreaking treatment for VEGF-mediated retinal diseases. It delivers vorolanib, a potent, selective, patent-protected tyrosine kinase inhibitor (TKI), through EyePoint’s proprietary sustained-release Durasert E technology. Vorolanib offers a novel mechanism for treating VEGF-mediated retinal diseases as a pan-VEGF receptor inhibitor, targeting all VEGF receptors. Additionally, vorolanib has shown neuroprotective properties in an in-vivo model of retinal detachment and may have antifibrotic benefits by blocking PDGF. Duravyu is shipped and stored at room temperature and is administered via a standard intravitreal injection. It becomes bioavailable immediately and releases the drug with zero-order kinetics for up to 9 months.¹

Duravyu is also being studied in the Phase 2 VERONA trial for diabetic macular edema (DME), with topline data expected in the first quarter of 2025.

Reference

1. EyePoint Announces First Patient Dosed in Second Global Phase 3 LUCIA Clinical Trial of DURAVYU for the Treatment of Wet Age-Related Macular Degeneration | EyePoint Pharmaceuticals. EyePoint Pharmaceuticals. Published 2024. Accessed December 4, 2024. https://investors.eyepointpharma.com/news-releases/news-release-details/eyepoint-announces-first-patient-dosed-second-global-phase-3