EyePoint Pharmaceuticals (NASDAQ:EYPT) completed enrollment in the Phase 2 “Durasert and Vorolanib in Ophthalmology 2” (DAVIO 2) clinical trial evaluating EYP-1901 as a potential six-month maintenance treatment for wet age-related macular degeneration (wet AMD).
The trial exceeded its original target of 144 patients, enrolling a total of 160 patients. All patients were previously treated with a standard-of-care anti-VEGF therapy and were randomly assigned to one-of-two doses of EYP-1901 or to an aflibercept on-label control. Aflibercept is sold under the brand name Eylea and Zaltrap.
“Patients with wet AMD face an immense treatment burden, requiring monthly or bi-monthly eye injections for the rest of their lives in order to prevent severe vision loss,” Nancy Lurker, CEO of EyePoint, said in a statement.
“The high level of patient and physician interest we saw in the trial enrollment further demonstrates the great unmet need in this population for a maintenance treatment option that is safe, effective, long-lasting and convenient,” she added.
The primary efficacy endpoint of the DAVIO 2 trial is change in best corrected visual acuity, compared with the aflibercept control, six-months after the EYP-1901 injection. EYP-1901 is delivered with a single intravitreal injection in the physician’s office, similar to current FDA approved anti-VEGF treatments. EyePoint expects to report topline data in the fourth quarter of 2023.