Ocuphire Pharma receives FDA agreement under SPA for LYNX-2 Phase 3 trial

Ocuphire Pharma announced it has received agreement from the U.S. Food and Drug Administration, FDA, under a Special Protocol Assessment, SPA, for the clinical trial protocol and planned statistical analysis of the LYNX-2 Phase 3 trial to evaluate phentolamine ophthalmic solution for the proposed indication for the treatment of decreased visual acuity under dim light conditions. “The SPA agreement with the FDA provides a clear regulatory path for phentolamine ophthalmic solution in patients with poor night vision after keratorefractive surgery,” said George Magrath, M.D., M.B.A, M.S, CEO of Ocuphire. “Preparations for the LYNX-2 Phase 3 trial have begun, and we anticipate patient enrollment to begin in the first quarter of 2024.” Ocuphire received written agreement from the FDA that the clinical trial protocol and planned statistical analysis of the LYNX-2 Phase 3 trial of phentolamine ophthalmic solution could adequately address objectives supporting regulatory submission and a potential future marketing application in this indication.