EyePoint Pharmaceuticals, Inc. announced positive topline results of its Phase 2 DAVIO 2 trial of EYP-1901, an investigational sustained delivery maintenance treatment for wet age-related macular degeneration (wet AMD) combining vorolanib, a selective tyrosine kinase inhibitor with bioerodible Durasert E?. The clinical trial met its primary endpoint with both EYP-1901 doses demonstrating statistical non-inferiority change in best corrected visual acuity compared to aflibercept control and a favorable safety profile with no EYP-1901-related ocular or systemic serious adverse events (SAEs). The trial also achieved key secondary endpoints with both EYP-1901 doses, including an over 80% reduction in treatment burden, nearly two-thirds of eyes supplement-free up to six months and over 80% receiving only zero or one supplement up to six-months.

Additionally, there was strong anatomical control with both EYP-1901 cohorts as measured by optical coherence tomography. DAVIO 2 topline interim results include: Both EYP-1901 doses (2mg and 3mg) achieved all primary and secondary endpoints. Statistical non-inferiority in change in BCVA (at a confidence interval of 95%) compared to aflibercept control, at weeks 28 and weeks 32 combined.

The 2mg and 3mg doses were only -0.3 and -0.4 letters different, respectively, versus on-label aflibercept. The lower limit of the non-inferiority margin is defined as a -4.5 letters by the FDA with 5 letters representing one line on the eye chart. Continued positive safety and tolerability profile with no EYP-1901-related ocular or systemic SAEs.

89% and 85% reduction in treatment burden, respectively, for the 2mg and 3mg EYP-1901 doses. 65% and 64% of eyes were supplement free up to six-months, respectively, for the 2mg and 3mg doses of EYP-1901. Both EYP-1901 doses demonstrated strong anatomic control with OCT difference below 10 microns at week 32 compared to the aflibercept control.

Patient discontinuation up to week 32 was low at 4%. DAVIO 2 is a randomized, controlled Phase 2 clinical trial of EYP-1901 in previously treated 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 non-inferiority efficacy endpoint is change in BCVA compared to the aflibercept control, approximately six-months after the EYP-1901 injection.

Secondary endpoints include safety, change in CST as measured by OCT, the number of eyes that remain free of supplemental anti-VEGF injections, and number of aflibercept injections in each group. EyePoint plans to present the DAVIO 2 dataset at Angiogenesis, Exudation, and Degeneration 2024 in February. The Company remains on track to reach additional clinical milestones with EYP-1901 with the initiation of the Phase 2 VERONA trial in diabetic macular edema (DME) anticipated in the first quarter of 2024 and the readout of topline data from the Phase 2 PAVIA trial in non-proliferative diabetic retinopathy anticipated in the second quarter of 2024.