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EyePoint Pharmaceuticals Announces First Patient Dosed in Phase 2 DAVIO 2 Clinical Trial of EYP-1901 for the Maintenance Treatment of Wet AMD
-Topline data expected in the second half of 2023- WATERTOWN, Mass., Aug. 1, 2022 /PRNewswire/ -- EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a
About this update from Eyepoint, Inc.
[{"type":"text","content":"-Topline data expected in the second half of 2023-\nWATERTOWN, Mass., Aug. 1, 2022 /PRNewswire/ -- EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a pharmaceutical company committed to developing and commercializing therapeutics to improve the lives of patients with serious eye disorders, today announced that the first patient has been dosed in the Phase 2 \"Durasert® and Vorolanib in Ophthalmology 2\" (DAVIO 2) clinical trial of EYP-1901, an investigational sustained delivery anti-vascular endothelial growth factor (anti-VEGF) treatment for wet age-related macular degeneration (wet AMD).\n\n \n \n \n \n \n \n\n \n\"We are very pleased to announce the initiation of the Phase 2 DAVIO 2 clinical trial of EYP-1901 for wet AMD. Using a 'Treat to Maintain' therapeutic approach, EYP-1901 has the potential to transform the wet AMD treatment landscape by sustaining a majority of patients up to six months without supplemental anti-VEGF treatment, thereby greatly reducing the treatment burden,\" said Nancy Lurker, Chief Executive Officer of EyePoint Pharmaceuticals. \"We are encouraged by the safety and efficacy results from our Phase 1 DAVIO trial, including no reports of ocular or drug related systemic serious adverse events and strong durability data with 53% of patients requiring no supplemental treatment up to six months. We anticipate initial topline data from our Phase 2 trial in the second half of 2023.\"\nThe twelve-month, randomized, controlled Phase 2 DAVIO 2 trial of EYP-1901 for wet AMD is expected to enroll approximately 150 patients, previously treated with a standard-of-care anti-VEGF therapy, randomly assigned to one of two doses of EYP-1901 (approximately 2 mg or 3 mg) or an aflibercept control. EYP-1901 is delivered with a single intravitreal injection in the physician's office, similar to current FDA approved anti-VEGF treatments. The primary efficacy endpoint of the DAVIO 2 trial is change in best corrected visual acuity (BCVA) compared to the aflibercept control six-months after the EYP-1901 injection. Secondary efficacy endpoints include change in central subfield thickness (CST) as measured by optical coherence tomography (OCT), time to first supplemental anti-VEGF, and safety. More information about the trial is available at clinicaltrials.gov (identifier: NCT05381948).\nAbout EYP-1901\nEYP-1901 is being developed ...