FDA Grants OKYO Pharma Fast Track Designation to Urcosimod for Neuropathic Corneal Pain

Core Viewpoint - OKYO Pharma Limited has received Fast Track designation from the FDA for urcosimod, aimed at treating neuropathic corneal pain (NCP), a condition currently lacking an FDA-approved therapy [1][4]. Company Overview - OKYO Pharma Limited is a clinical stage biopharmaceutical company focused on developing innovative therapies for neuropathic corneal pain and dry eye disease, with its shares traded on the NASDAQ Capital Market [8]. Product Development - Urcosimod, previously known as OK-101, is being developed to address NCP, characterized by severe eye pain due to nerve damage [1][3]. - The Phase 2 trial for urcosimod is a double-masked, randomized, 12-week placebo-controlled study involving patients with confirmed NCP [6]. FDA Fast Track Designation - The Fast Track designation is intended to expedite the development and review of therapies for serious conditions, providing benefits such as more frequent FDA meetings and eligibility for Accelerated Approval [2]. - This designation highlights the urgent medical need for effective treatments for NCP, which is currently managed through off-label therapies [5]. Mechanism of Action - Urcosimod is a lipid-conjugated chemerin peptide agonist targeting the ChemR23 G-protein coupled receptor, involved in the inflammatory response and pain management [7]. - The drug has demonstrated anti-inflammatory and pain-reducing effects in preclinical models, with a design aimed at enhancing its residence time in the ocular environment [7].