EyePoint Pharmaceuticals, Inc. announced interim masked safety data and baseline patient demographics from its Phase 2 DAVIO 2 clinical trial of EYP-1901, a potential sustained delivery maintenance treatment for wet age-related macular degeneration (wet AMD). These data are being presented at the OIS Retina Innovation Summit in Seattle, WA by Nancy Lurker, Executive Vice-Chair of EyePoint Pharmaceuticals. A masked safety summary as of July 1, 2023 found that there have been no reported drug-related ocular SAEs and no reported drug-related systemic SAEs in the DAVIO 2 trial.

There were two ocular SAEs unrelated to EYP-1901 in the trial: Retinal detachment in a study eye detected at week 1 (one week post initial aflibercept injection, prior to EYP-1901 injection); Retinal hemorrhage in a non-study fellow eye. The company also presented the Phase 2 DAVIO 2 trial screening characteristics and provided a comparison to baseline demographics of the Phase 1 DAVIO patients. Interim baseline data on patients in the Phase 2 DAVIO 2 trial as of July 1, 2023 reveal that patients feature a mean best corrected visual acuity (BCVA) of 74 letters, compared with a mean BCVA of 69 letters in the Phase 1 DAVIO trial.

Mean CST in the Phase 2 DAVIO 2 trial was 265 µm, compared to 299 µm in the Phase 1 DAVIO trial. Mean age of patients in the Phase 2 DAVIO 2 trial is 76 years old, compared to 77.4 years old in the Phase 1 DAVIO trial. DAVIO 2 is a randomized, controlled Phase 2 clinical trial of EYP-1901 in patients with previously treated wet AMD.

All enrolled patients had been previously treated with 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 BCVA compared to the aflibercept control, six-months after the EYP-1901 injection.

Secondary efficacy endpoints include change in 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).