EyePoint announces EYP-1901 achieved primary endpoints in Phase 2 trial

EyePoint Pharmaceuticals 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 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. 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 achieved all primary and secondary endpoints. Statistical non-inferiority in change in BCVA 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%.