OKYO Pharma Announces Successful Type C Meeting with the FDA

Core Insights - OKYO Pharma Limited has successfully held a Type C meeting with the FDA regarding the Phase 2b/3 clinical trial of urcosimod for treating neuropathic corneal pain (NCP) [1][2] - The FDA's alignment on the clinical development program for urcosimod is seen as a significant step forward in addressing the unmet medical need for patients suffering from NCP [2][6] - Urcosimod has received the first IND to treat NCP and has been granted fast track designation by the FDA, with a 120-patient Phase 2b/3 study expected to begin in the first half of the year [2][7] Company Overview - OKYO Pharma is a clinical-stage biopharmaceutical company focused on developing therapies for neuropathic corneal pain and inflammatory eye diseases, with its shares traded on the Nasdaq Capital Market [7] - The company has recently completed a successful Phase 2 trial of urcosimod in NCP patients and is preparing for further clinical studies [7] Neuropathic Corneal Pain (NCP) - NCP is a chronic condition characterized by severe eye pain and sensitivity, often resulting from damage to corneal sensory nerves, with no FDA-approved therapies currently available [3] - Patients with NCP often rely on off-label treatments with limited success [3] Urcosimod Details - Urcosimod is a lipid-conjugated chemerin peptide agonist that has demonstrated anti-inflammatory and pain-reducing effects in preclinical models [4] - Positive data from a Phase 2 trial indicated significant pain reduction in NCP patients, supporting its potential as a treatment option [4] FDA Meeting Highlights - The FDA confirmed that the proposed primary endpoint of Visual Analogue Scale (VAS) pain reduction at Week 12 is clinically meaningful, with a ≥2-point improvement indicating a significant treatment effect [6] - The FDA provided guidance on statistical analysis and endorsed the study design, sample size, and powering assumptions, which de-risks the pathway to a pivotal trial [6]