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WATERTOWN, Mass. – EyePoint Pharmaceuticals, Inc. (NASDAQ: NASDAQ:) has announced new subgroup analyses from its Phase 2 DAVIO 2 clinical trial, which highlight the potential of EYP-1901 as a treatment for wet age-related macular degeneration (wet AMD (NASDAQ:)). The data, presented at the Angiogenesis, Exudation, and Degeneration 2024 Virtual Meeting on Sunday, suggest EYP-1901 could alter the treatment paradigm for patients with this retinal disease.
EYP-1901 combines vorolanib, a tyrosine kinase inhibitor, with the bioerodible Durasert E technology for sustained delivery. The subgroup analysis showed numerical superiority in visual acuity and anatomic stability for patients treated with EYP-1901 compared to those given aflibercept, without the need for supplemental injections up to six months.
The Phase 2 DAVIO 2 trial met its primary endpoint, with EYP-1901 demonstrating statistical non-inferiority in visual acuity changes and a favorable safety profile compared to aflibercept. Secondary endpoints were also achieved, notably a significant reduction in treatment burden and strong anatomical control.
EyePoint CEO Jay Duker, M.D., expressed confidence in the data, affirming that the positive outcomes were attributable to EYP-1901. The company plans to initiate Phase 3 trials in the second half of 2024, following discussions with the U.S. Food and Drug Administration (FDA).
Wet AMD is a leading cause of vision loss in individuals over 60, and current treatments require frequent injections. EYP-1901’s sustained delivery could reduce this burden, with the recent trial showing up to 88% treatment burden reduction at six months.
EyePoint Pharmaceuticals is also progressing with other clinical milestones for EYP-1901, including a Phase 2 trial in non-proliferative diabetic retinopathy, with topline data expected in the second quarter of 2024.
This report is based on a press release statement from EyePoint Pharmaceuticals. The company is dedicated to the development and commercialization of therapeutics for serious retinal diseases. Its pipeline features the proprietary Durasert E technology for intraocular drug delivery. EyePoint’s lead product candidate, EYP-1901, is under investigation for several VEGF-mediated retinal diseases.
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