Why Is Age-Related Blindness Focused EyePoint Pharmaceuticals Stock Trading Over 300% Today?

EyePoint Pharmaceuticals Inc EYPT announced 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 (2mg and 3mg) demonstrating a statistical non-inferiority change in best corrected visual acuity (BCVA) compared to aflibercept control and a favorable safety profile with no EYP-1901-related ocular or systemic serious adverse events (SAEs). 

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 -4.5 letters by the FDA, with five letters representing one line on the eye chart.

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. 

65% and 64% of eyes were supplement free up to six-months, respectively, for the 2mg and 3mg doses of EYP-1901.

Additionally, there was strong anatomical control with both EYP-1901 cohorts as measured by optical coherence tomography (OCT).

Patient discontinuation up to week 32 was low at 4%.

The company remains on track to initiate the Phase 2 VERONA trial in diabetic macular edema, anticipated in Q1 of 2024, and the readout of topline data from the Phase 2 PAVIA trial in non-proliferative diabetic retinopathy, expected in Q2 of 2024.

Price Action: EYPT shares are up 288.8% at $25.71 during the premarket session on the last check Monday.