Core Insights - OKYO Pharma Ltd has announced significant topline data from its Phase 2 trial of urcosimod for treating neuropathic corneal pain, a condition with no FDA-approved treatments [1][4][11] - The trial was randomized, placebo-controlled, and involved 48 patients, with confocal microscopy used to confirm the presence of neuropathic pain [1][8][10] - The study was halted early after 17 patients completed 12 weeks of treatment due to notable pain reduction in those receiving urcosimod topically [2][10] Company Overview - OKYO Pharma is pioneering the development of the first drug specifically targeting neuropathic corneal pain, which is described as severe nerve pain comparable to having a spinal cord injury in the eye [5][11] - The company has received fast track designation from the FDA, allowing for an accelerated development process towards drug approval [11][12] Clinical Trial Details - The Phase 2 trial commenced in October and was designed to ensure that participants had neuropathic pain rather than inflammatory pain [8][9] - The decision to stop the trial early was made to assess the drug's effectiveness sooner, with the aim of moving forward with discussions with the FDA based on the preliminary data [10][12][13] Future Steps - Following the positive data from the trial, the company plans to approach the FDA to discuss the next stages of development for urcosimod [11][12] - The urgency in halting the trial early reflects the company's commitment to addressing the needs of patients suffering from a condition with no current approved treatments [14]

Core Insights - OKYO Pharma Limited announced positive top-line data from an 18-patient Phase 2 trial of urcosimod for treating neuropathic corneal pain (NCP), a condition with no FDA-approved therapy [1][8] - The trial demonstrated significant pain reduction in patients treated with urcosimod compared to placebo, indicating its potential effectiveness [4][5] Trial Details - The Phase 2 trial was a randomized, double-masked, placebo-controlled study conducted at Tufts Medical Center in Boston, MA, led by Dr. Pedram Hamrah [2][12] - The primary endpoint was the change in mean pain scores from baseline to the end of treatment, measured by a Visual Analogue Scale (VAS) [3] Results Summary - In the per-protocol population, the mean pain score change was 5.5 for the 0.05% urcosimod group versus 2.75 for the placebo group, showing a delta difference of 2.75 [4] - 75% of patients in the urcosimod group achieved over 80% improvement in pain severity, with significant reductions observed as early as Week 4 [8] - In the intent-to-treat population, 67% of patients in the urcosimod group showed greater than 50% improvement in pain compared to 33% in the placebo group [5] Statistical Significance - A statistically significant reduction in mean pain scores was observed in the urcosimod group (p-value = 0.025), while the placebo group also showed improvement (p-value = 0.035) [4][8] - The drug-effect size for urcosimod compared to placebo at week 12 demonstrated a strong treatment effect (Cohen-d value > 1.2) [6] Future Plans - Following the trial, OKYO plans to meet with the FDA to discuss next steps for urcosimod, which has received Fast Track designation for treating NCP [8] - The company is also considering the "Expanded Access" program for patients who completed the trial [9] About Urcosimod - Urcosimod is a lipid conjugated chemerin peptide agonist designed to treat ocular diseases, showing anti-inflammatory and pain-reducing activities in preclinical models [13] - The drug has previously shown efficacy in a Phase 2 trial for dry eye disease, indicating its potential across multiple ocular conditions [10]

Core Insights - OKYO Pharma Limited is a clinical-stage biopharmaceutical company focused on developing therapies for neuropathic corneal pain and inflammatory eye diseases, with its lead candidate being urcosimod [1][4] Group 1: Presentation Information - Dr. Gary S. Jacob, CEO of OKYO Pharma, will present at the Bio International Convention 2025 in Boston, covering the clinical development of urcosimod for neuropathic corneal pain [2] - The convention will take place from June 16 to June 19, 2025, at the Boston Convention & Exhibition Center [2] Group 2: Neuropathic Corneal Pain (NCP) - NCP is characterized by severe pain and sensitivity in the eyes, face, or head, often resulting from nerve damage and inflammation [2] - Current treatments for NCP are limited and primarily off-label, indicating a significant unmet medical need [2] Group 3: Urcosimod Development - Urcosimod, previously known as OK-101, is a lipid-conjugated chemerin peptide agonist targeting the ChemR23 receptor, involved in the inflammatory response [3] - The drug has demonstrated anti-inflammatory and pain-reducing effects in preclinical models and is designed to enhance its residence time in the ocular environment [3] - Urcosimod has shown statistical significance in a Phase 2 trial for dry eye disease and is currently being evaluated in a Phase 2 trial for neuropathic corneal pain [3] Group 4: Company Overview - OKYO Pharma is listed on the NASDAQ Capital Market and is dedicated to discovering and developing novel molecules for treating ocular diseases [4] - The company is actively pursuing clinical trials for urcosimod in both dry eye disease and neuropathic corneal pain [4]