EyePoint Pharmaceuticals has announced the dosing of the first patient in the LUCIA trial, a global Phase 3 clinical trial evaluating DURAVYU for the treatment of wet age-related macular degeneration (wet AMD). This marks a significant step in the development of a sustained-release therapy that aims to reduce the burden of frequent intravitreal injections for patients with this sight-threatening condition.
DURAVYU (formerly EYP-1901) delivers vorolanib, a selective tyrosine kinase inhibitor (TKI), via EyePoint's Durasert E technology, designed for sustained intraocular release. The LUCIA trial (NCT06683742) is a randomized, double-masked, aflibercept-controlled, non-inferiority study.
Trial Design and Objectives
The LUCIA trial, along with the LUGANO trial (NCT06668064), aims to enroll approximately 400 patients globally. Participants will be randomized to receive either a 2.7mg dose of DURAVYU or on-label aflibercept. Patients in the DURAVYU arm will receive intravitreal injections 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 versus baseline. Secondary endpoints include safety, reduction in treatment burden, the percentage of eyes free of supplemental aflibercept injections, and anatomical outcomes measured by optical coherence tomography (OCT).
Adam Gerstenblith, MD, principal investigator in the LUCIA clinical trial and vitreoretinal surgeon at Mid Atlantic Retina Specialists, highlighted the burden of current treatments: "Patients with wet AMD typically require life-long treatment with frequent intravitreal injections to preserve their vision. This high treatment burden often results in under-treatment and irreversible vision loss."
Addressing Unmet Needs in Wet AMD Treatment
Wet AMD is a leading cause of vision loss in individuals over 50, characterized by abnormal blood vessel growth in the macula. Current standard-of-care treatments, primarily anti-VEGF injections, require frequent administration, often every two months, posing a significant burden on patients and healthcare systems. This can lead to non-compliance and subsequent vision loss.
Jay S. Duker, MD, President and Chief Executive Officer of EyePoint, stated, "Dosing the first patient in our second global Phase 3 clinical trial, the LUCIA trial, marks another significant milestone demonstrating our continued focus on execution at EyePoint. We are encouraged by the robust physician and patient interest in DURAVYU with enrollment in our first pivotal trial, the LUGANO trial, exceeding our expectations."
Vorolanib: A Novel Approach to VEGF Inhibition
Vorolanib, the active drug in DURAVYU, is a potent, selective, and patent-protected tyrosine kinase inhibitor (TKI). It acts as a pan-VEGF receptor inhibitor, blocking all VEGF receptors. Preclinical data suggest vorolanib may also offer neuroprotective and antifibrotic benefits. DURAVYU is administered via a standard intravitreal injection and is designed to release the drug over at least six months.
Anticipated Timeline and Future Studies
Topline data from the Phase 3 pivotal program is anticipated in 2026. 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.
Ramiro Ribeiro, MD, PhD, Chief Medical Officer of EyePoint, emphasized the potential impact of the LUCIA and LUGANO 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."
