EyePoint Pharmaceuticals Announces First Patient Dosed in Phase 2 DAVIO 2 Clinical Trial of EYP-1901 for the Maintenance Treatment of Wet AMD

EyePoint Pharmaceuticals, Inc., announced that the first patient has been dosed in the Phase 2 Durasert® and Vorolanib in Ophthalmology 2 (DAVIO 2) clinical trial of EYP-1901, an investigational sustained delivery antivascular endothelial growth factor (anti-VEGF) treatment for wet age-related macular degeneration (AMD).

"We are very pleased to announce the initiation of the Phase 2 DAVIO 2 clinical trial of EYP-1901 for wet AMD. Using a 'treat to maintain' therapeutic approach, EYP-1901 has the potential to transform the wet AMD treatment landscape by sustaining a majority of patients up to 6 months without supplemental anti-VEGF treatment, thereby greatly reducing the treatment burden," said Nancy Lurker, CEO of EyePoint Pharmaceuticals. "We are encouraged by the safety and efficacy results from our Phase 1 DAVIO trial, including no reports of ocular or drug-related systemic serious adverse events and strong durability data with 53% of patients requiring no supplemental treatment up to 6 months. We anticipate initial topline data from our Phase 2 trial in the second half of 2023."

The 12-month, randomized, controlled Phase 2 DAVIO 2 trial of EYP-1901 for wet AMD is expected to enroll approximately 150 patients, previously treated with a standard-of-care anti-VEGF therapy, 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 compared to the aflibercept control 6-months after the EYP-1901 injection. Secondary efficacy endpoints include change in central subfield thickness as measured by optical coherence tomography, time to first supplemental anti-VEGF, and safety. More information about the trial is available at clinicaltrials.gov (identifier: NCT05381948).