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EyePoint Pharmaceuticals to Highlight DURAVYUTM (vorolanib intravitreal insert) Clinical and Regulatory Progress and Pipeline Innovation at R&D Day 2024
– Phase 3 trial design for the LUGANO and LUCIA pivotal non-inferiority trials of DURAVYU in wet AMD based on positive EOP2 meeting with FDA; on track for
About this update from Eyepoint, Inc.
[{"type":"text","content":"– Phase 3 trial design for the LUGANO and LUCIA pivotal non-inferiority trials of DURAVYU in wet AMD based on positive EOP2 meeting with FDA; on track for trial initiation in 2H 2024 – – Positive twelve-month safety and efficacy data from Phase 2 DAVIO 2 clinical trial evaluating DURAVYU for the treatment of wet AMD reinforces potential as a sustained six-month maintenance therapy – – Phase 2 trial of DURAVYU in diabetic macular edema (DME) fully enrolled – – EyePoint to webcast its R&D Day event today at 8:00 a.m. ET – WATERTOWN, Mass., June 26, 2024 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a company committed to developing and commercializing therapeutics to help improve the lives of patients with serious retinal diseases, today announced the Company will highlight clinical and regulatory developments for its lead pipeline program, DURAVYU™ (vorolanib intravitreal insert), formerly known as EYP-1901, its Durasert E™ sustained drug delivery technology, and early-stage programs during EyePoint’s R&D Day today, Wednesday, June 26, 2024, from 8:00 a.m. to 9:30 a.m. ET. “EyePoint continues to pioneer the development of sustained-release drug delivery treatments for serious retinal diseases with DURAVYU™, a potentially paradigm-shifting, best-in-class treatment for patients suffering from VEGF-mediated retinal diseases,” said Jay Duker, M.D., President and Chief Executive Officer of EyePoint Pharmaceuticals. “We have a track record of strong execution, establishing the most robust dataset among sustained delivery TKI programs in wet age-related macular degeneration. We are excited to share the positive twelve-month DAVIO 2 clinical trial data for DURAVYU, as well as our Phase 3 clinical trial plans for wet age-related macular degeneration (wet AMD), with first patient dosing anticipated in the second half of this year. Importantly, our planned Phase 3 design includes redosing, consistent with expected commercial use. We believe DURAVYU and our earlier-stage programs, including EYP-2301, are potentially multi-billion-dollar product opportunities, and we remain laser focused on advancing our mission of improving patient vision with innovative treatment options.” R&D Day will feature commentary from EyePoint’s management team as well as key opinion leader (KOL) guest speakers, Carl D. Regillo, M.D., FACS, Prof...