First patient dosed in Phase 2 DAVIO trial for wet AMD

EyePoint Pharmaceuticals Inc. this week 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 anti-vascular endothelial growth factor (anti-VEGF) treatment for wet age-related macular degeneration (wet AMD).

Nancy Lurker, CEO of EyePoint Pharmaceuticals, noted in a news release that by taking advantage of 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.

“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 six months. We anticipate initial topline data from our Phase 2 trial in the second half of 2023,” she said in the release.

According to the company, the 123-month, randomly assigned, 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.

Moreover, the company also noted that the primary efficacy endpoint of the DAVIO 2 trial is change in best corrected visual acuity (BCVA) compared to the aflibercept control 6-months after the EYP-1901 injection. Secondary efficacy endpoints include change in central subfield thickness (CST) as measured by optical coherence tomography (OCT), time to first supplemental anti-VEGF, and safety. More information about the trial is available at clinicaltrials.gov (NCT05381948).

According to the company, EYP-1901 is being developed as an investigational sustained delivery treatment combining a bioerodible formulation of EyePoint's Durasert delivery technology with vorolanib, a tyrosine kinase inhibitor. Positive 12-month safety and efficacy data from the DAVIO Phase 1 clinical trial of EYP-1901 showed no reports of ocular or drug-related systemic serious adverse events and no dose limiting toxicities with stable visual acuity and OCT.