EyePoint announced results from new subgroup analyses from Phase 2 DAVIO 2 trial

EyePoint Pharmaceuticals announced results from new subgroup analyses from the Phase 2 DAVIO 2 clinical trial of EYP-1901, an investigational sustained delivery maintenance treatment for wet age-related macular degeneration combining vorolanib, a selective tyrosine kinase inhibitor with bioerodible Durasert E. The analyses of the data reveal: In the sub-group of patients who were supplement-free up to 6 months, the EYP-1901 groups demonstrated numerical superiority in change in BCVA along with strong anatomic control compared to the aflibercept control group. This result confirms that the positive topline data from the Phase 2 DAVIO 2 trial were driven by EYP-1901 and not by study eyes requiring supplemental injection. Visual and anatomical outcomes were not meaningfully influenced by differences in patient baseline BCVA, duration of wet AMD diagnosis, or historical treatment burden. EYP-1901outcomes are consistent and durable in a range of wet AMD patient types. A second presentation also included the previously reported positive topline results of its Phase 2 DAVIO 2 trial of EYP-1901. The 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. The trial also achieved key secondary endpoints with both EYP-1901 doses, including an approximately 85% mean reduction in historical treatment burden, nearly two-thirds of eyes supplement-free up to six months and over 83% receiving only zero or one supplement up to six-months. Additionally, there was strong anatomical control in both EYP-1901 cohorts as measured by optical coherence tomography. Phase 2 DAVIO 2 12-month results and the initiation of a Phase 3 trial in wet AMD are both expected in the second half of 2024. The company remains on track to report additional clinical milestones with EYP-1901 this year with the readout of topline data from the Phase 2 PAVIA trial in non-proliferative diabetic retinopathy anticipated in the second quarter of 2024.