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EyePoint Pharmaceuticals Announces Positive Topline Data from the Phase 2 DAVIO 2 Trial of EYP-1901 in Wet AMD Achieving All Primary and Secondary Endpoints
– Both EYP-1901 cohorts demonstrated a statistically non-inferior change in BCVA versus aflibercept control with a numerical difference of only -0.3 and -0.4
About this update from Eyepoint, Inc.
[{"type":"text","content":"– Both EYP-1901 cohorts demonstrated a statistically non-inferior change in BCVA versus aflibercept control with a numerical difference of only -0.3 and -0.4 letters, respectively for the 2 mg and 3 mg dose at blended six-month endpoint – – Positive safety profile continues with no EYP-1901-related ocular or systemic SAEs – – Key secondary endpoints were achieved with both EYP-1901 doses. These include an over 80% reduction in treatment burden, with nearly two-thirds of eyes supplement-free up to six-months – – Strong anatomical control in both EYP-1901 cohorts documented by optical coherence tomography (OCT) – – Conference call to discuss the results to be held today, December 4, 2023 at 8:00 a.m. ET – WATERTOWN, Mass., Dec. 04, 2023 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a company committed to developing and commercializing therapeutics to improve the lives of patients with serious retinal diseases, today 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 (BCVA) 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 (OCT). “We are incredibly pleased by these highly positive Phase 2 results which underscore EYP-1901’s potential as a paradigm-altering maintenance treatment for patients with wet AMD, with a positive safety profile. Since EYP-1901 achieved statistical non-inferiority to the aflibercept control in this trial there is potential for meaningfully lower sized and lower cost pivotal Phase 3 trials,” said Jay S. Duker, M.D., President and Chief Executive Officer of EyePoint ...