FDA Approves Compassionate Use of Urcosimod (0.05%) for the Treatment of Neuropathic Corneal Pain

Core Insights - OKYO Pharma Limited has received FDA authorization for a single-patient expanded access IND application for urcosimod, aimed at treating neuropathic corneal pain (NCP) [1][2] Company Overview - OKYO Pharma is a clinical-stage biopharmaceutical company focused on developing therapies for NCP and inflammatory eye diseases, with shares traded on the Nasdaq Capital Market [6] - The company plans to initiate a 120-patient Phase 2b/3 multiple-dose study of urcosimod for NCP this year [6] Product Information - Urcosimod is a lipid conjugated chemerin peptide agonist targeting the ChemR23 receptor, which is involved in inflammatory responses and pain signaling [5] - Positive results were reported from a Phase 2 trial showing significant pain reduction in NCP patients, with urcosimod demonstrating statistical significance in multiple endpoints [5] Disease Context - Neuropathic corneal pain is a chronic condition characterized by severe eye pain and sensitivity, often resulting from corneal nerve damage and inflammation [4] - There are currently no FDA-approved treatments specifically for NCP, leading to limited therapeutic options for patients [4]