Topline data for Phase 3 pivotal program anticipated in 2026.
EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a company committed to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases, announced that the first patient has been dosed in the LUCIA trial, the company’s second global phase 3 clinical trial of DURAVYU, formerly EYP-1901, for the treatment of wet age-related macular degeneration (wet AMD).
DURAVYU is an investigational sustained delivery therapy delivering patent-protected vorolanib, a selective tyrosine kinase inhibitor formulated in proprietary bioerodible Durasert E™ for sustained intraocular delivery.
“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,” said Jay S. Duker, MD, president and CEO of 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. With two simultaneous phase 3 clinical trials underway, the most robust clinical dataset of all long-acting treatments in development for wet AMD, and a strong balance sheet, we are well-positioned as the leader in sustained-release ocular drug delivery bringing impactful therapies to patients suffering from serious retinal diseases.”
“We are pleased to have dosed the first patient in the LUCIA trial so soon after dosing the first patient in the LUGANO trial. This underscores our commitment to develop innovative therapies with the potential to change the current treatment paradigm in wet AMD,” said Ramiro Ribeiro, MD, PhD, chief medical officer of EyePoint. “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. 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.”
“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,” said Adam Gerstenblith, MD, principal investigator in the LUCIA clinical trial and vitreoretinal surgeon at Mid Atlantic Retina Specialists. “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 six months, which aligns well with how we would approach potential treatment using DURAVYU in clinical practice. We are proud to be the site to treat a patient with DURAVYU in the LUCIA trial and we look forward to continuing to work with EyePoint to rapidly enroll patients in this critical phase 3 program.”
LUGANO and LUCIA are global, randomized, double-masked, aflibercept controlled, non-inferiority phase 3 trials assessing the efficacy and safety of DURAVYU in patients with active wet AMD including treatment naïve and treatment experienced patients. Each trial is expected to enroll approximately 400 patients globally who will be randomly assigned to a 2.7mg dose of DURAVYU or an on-label aflibercept control.
The LUGANO and LUCIA trials are the only sustained release wet AMD pivotal phase 3 trials evaluating re-dosing in both trials. Patients in the DURAVYU treatment arm will receive an intravitreal injection of DURAVYU every six months, starting at month two 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). More information about the trial is available at clinicaltrials.gov (LUGANO identifier: NCT06668064; LUCIA identifier: NCT06683742).
About DURAVYU
DURAVYUTM, f/k/a EYP-1901, is being developed as a potential paradigm-altering treatment for patients suffering from VEGF-mediated retinal diseases. DURAVYU delivers vorolanib, a potent, selective and patent-protected tyrosine kinase inhibitor (TKI) as a solid bioerodible insert using EyePoint’s proprietary sustained-release Durasert E technology.
Vorolanib brings a new mechanistic approach to the treatment of VEGF-mediated retinal diseases as a pan-VEGF receptor inhibitor, inhibiting all VEGF receptors. Further, in an in-vivo model of retinal detachment, vorolanib demonstrated neuroprotection and may have antifibrotic benefits as it also blocks PDGF. DURAVYU is shipped and stored at ambient temperature and is administered with a standard intravitreal injection in the physician's office. DURAVYU is immediately bioavailable with zero-order kinetics release for at least six months.
Positive data from both the phase 1 DAVIO and phase 2 DAVIO 2 clinical trials of DURAVYU in wet AMD demonstrated clinically meaningful efficacy data with stable visual acuity and CST and a favorable safety profile.
Further, data from DAVIO 2 demonstrated an impressive treatment burden reduction of approximately 88% at eight months, six months after treatment with DURAVYU, with over 80% of patients supplement-free or receiving only one supplemental anti-VEGF injection through up to eight months, six months after treatment with DURAVYU.
The data from the DAVIO 2 clinical trial supported the advancement of the wet AMD program and the initiation of the global phase 3 clinical trials, LUGANO and LUCIA.
DURAVYU is also currently being studied in the phase 2 VERONA trial for diabetic macular edema (DME). Full topline data is expected in the first quarter of 2025.