OKYO Pharma Announces Registration Pathway with 100 Patient Multi-Center Clinical Trial of Urcosimod in Neuropathic Corneal Pain

Core Viewpoint - OKYO Pharma Limited is advancing the clinical development of urcosimod, a drug aimed at treating neuropathic corneal pain (NCP), following promising results from a Phase 2 trial that showed significant pain reduction in patients [1][3][5] Group 1: Clinical Development - The company plans to initiate a multiple-ascending-dose (MAD) clinical trial to further evaluate urcosimod, with topline data expected in 2026 [3][4] - The Phase 2 trial conducted at Tufts Medical Center involved 17 patients and demonstrated that 75% of those receiving 0.05% urcosimod experienced over 80% pain reduction [2][3][7] - OKYO is negotiating with several leading U.S. clinical sites for the upcoming MAD trial, which aims to enroll approximately 100 NCP patients [3][8] Group 2: Regulatory Pathway - Urcosimod has received Fast-Track designation from the FDA, which is anticipated to facilitate a quicker registration process [4][5] - The company is preparing for a meeting with the FDA to discuss the requirements for an approvable drug and to define the primary endpoint for potential registration [4][5] Group 3: Product Information - Urcosimod is a lipid-conjugated chemerin peptide agonist designed to treat ocular diseases by targeting immune cells and neurons involved in inflammation and pain [9] - The drug has shown anti-inflammatory and pain-reducing effects in preclinical models and has completed a Phase 2 trial for both dry eye disease and NCP [9][10] Group 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 NASDAQ [10]