– Second phase 3 LUCIA pivotal trial first patient dosing expected by end of 2024
– Topline data anticipated in 2026
EyePoint Pharmaceuticals, Inc. announced that the first patient has been dosed in the phase 3 LUGANO 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.
“Dosing the first patient in the global phase 3 LUGANO trial represents a significant milestone for EyePoint and DURAVYU, underscoring our leadership in sustained-release ocular drug delivery and commitment to developing innovative therapies for patients with serious retinal diseases,” said Jay S. Duker, MD, president and CEO of EyePoint. “Our phase 3 LUGANO and LUCIA trials were designed for potential global regulatory and commercial success based on our alignment with the FDA, as they follow a proven non-inferiority approval pathway. We have entered phase 3 leveraging learnings from our robust DAVIO and DAVIO 2 clinical trials to facilitate accelerated enrollment so that wet AMD patients may receive this potentially paradigm-shifting treatment as fast as possible.”
“With over 150 clinical trial sites already committed, we believe we are well positioned to rapidly enroll patients globally in the pivotal LUGANO trial, with the LUCIA trial to quickly follow,” said Ramiro Ribeiro, MD, PhD, chief medical officer of EyePoint. “We are encouraged by the exceptional patient and investigator enthusiasm for our phase 3 protocol, which aligns with clinical practice by including active treatment through trial duration. Patients will receive DURAVYU every six months or on-label aflibercept every two months, beginning after three loading doses of aflibercept with randomization occurring on Day 1. Further, the trials include both treatment-naïve and treatment experienced patients, which we believe more accurately represent the real-world patient population and increases our probability of success based on the positive DAVIO 2 data. We are optimistic that DURAVYU has the potential to change the current treatment paradigm and revolutionize clinical outcomes for patients suffering from serious retinal diseases.”
“Wet AMD patients face significant unmet need for a safe and efficacious sustained delivery treatment, as the current standard of care requires frequent injections resulting in a high treatment burden and, ultimately, delayed or missed appointments that potentially leave patients with no active drug to prevent disease progression and associated vision loss,” said Carl Regillo, M.D., FACS, director of Retina Service at Wills Eye Hospital and professor of Ophthalmology at Thomas Jefferson University. “Based on the promising clinical data generated in the DAVIO and DAVIO 2 trials, as well as the favorable safety profile from over 190 patients treated, I believe DURAVYU has the potential to improve the treatment paradigm for this lifelong disease by maintaining a majority of patients with active disease with no supplemental anti-VEGF therapy for six months or longer. The pivotal trials of DURAVYU in wet AMD represent an exciting milestone for patients, caregivers and physicians as we work to improve quality of life and patient vision.”
“Despite new treatments entering the wet AMD market, there remains a need for safe and durable treatments that provide sustained treatment while decreasing the patient’s need for frequent injections,” said Ashkan M. Abbey, MD, a principal investigator in the LUGANO clinical trial and director of Clinical Research at Texas Retina Associates. “DURAVYU brings a new mechanism of action with the potential to treat wet AMD patients every six months or longer to actively safeguard patients’ vision between visits. We are proud to be the first site to treat a patient in the LUGANO clinical trial, and we look forward to continuing to collaborate with EyePoint to rapidly enroll patients.”
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 previously treated and treatment-naïve 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).