EyePoint Pharmaceuticals Completes Enrollment in Oversubscribed Phase 2 DAVIO 2 Clinical Trial of EYP-1901 for Maintenance Treatment of Wet AMD - Seite 2

DAVIO 2 is a randomized, controlled Phase 2 clinical trial of EYP-1901 in patients with wet AMD. Originally designed to enroll 144 patients, the trial enrolled 160 patients in total due to strong investigator and patient interest. All enrolled patients were previously treated with a standard-of-care anti-VEGF therapy and were randomly assigned to one of two doses of EYP-1901 (approximately 2 mg or 3 mg) or an aflibercept control. EYP-1901 is delivered with a single intravitreal injection in the physician's office, similar to current FDA approved anti-VEGF treatments. The primary efficacy endpoint of the DAVIO 2 trial is change in best corrected visual acuity (BCVA) compared to the aflibercept control, six-months after the EYP-1901 injection. Secondary efficacy endpoints include change in central subfield thickness (CST) as measured by optical coherence tomography (OCT), number of eyes that remain free of supplemental anti-VEGF injections, number of aflibercept injections in each group, and safety. More information about the trial is available at clinicaltrials.gov (identifier: NCT05381948).

“Our ‘Treat to Maintain’ therapeutic approach for EYP-1901 has the potential to transform the wet AMD treatment paradigm, and we are incredibly pleased to complete enrollment with more patients than planned in the DAVIO 2 clinical trial due to high demand to participate from investigators and patients,” said Jay Duker, M.D., President and Chief Operating Officer of EyePoint Pharmaceuticals. “The compelling Phase 1 DAVIO results demonstrate EYP-1901’s potential to transition a majority of patients to an every-six-month treatment for wet AMD, representing a ‘treat to maintain’ therapeutic approach that uses EYP-1901 as a baseline therapy following the use of large molecule anti-VEGFs with the goal of significantly extending the patient’s treatment interval. Based on the extensive prior clinical data evaluating Durasert in four FDA-approved indications, we are confident in EYP-1901’s ability to consistently deliver the active drug, vorolanib, with zero-order drug release kinetics using our bioerodible sustained delivery technology, Durasert E. In addition, vorolanib brings a new mechanism of action for wet AMD patients and may have additional neuroprotective benefits. We are confident in EYP-1901’s potential to enhance treatment compliance, improve clinical experience and, ultimately, result in better patient outcomes.”