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 ordinary shares listed on NASDAQ [3] - The company is developing urcosimod, a novel drug candidate aimed at treating neuropathic corneal pain, which currently lacks an FDA-approved therapy [1][3] Product Development - Urcosimod, formerly known as OK-101, is a lipid conjugated chemerin peptide agonist targeting the ChemR23 G-protein coupled receptor, which is involved in the inflammatory response in the eye [2] - The drug has demonstrated anti-inflammatory and pain-reducing effects in preclinical models and has shown statistical significance in multiple endpoints during a completed Phase 2 trial for dry eye disease [2] - A recent randomized, placebo-controlled, double-masked Phase 2 trial for urcosimod to treat neuropathic corneal pain has also been completed [2][3] Recent Developments - Gabriele Cerrone, the Executive Chairman of OKYO, has increased his holdings in the company by acquiring an additional 210,000 shares, bringing his total to 10,382,677 shares [1]

Group 1 - Proactive provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The news team specializes in medium and small-cap markets while also covering blue-chip companies, commodities, and broader investment stories [3] - Proactive has a global presence with bureaus and studios in key finance and investing hubs including London, New York, Toronto, Vancouver, Sydney, and Perth [2][3] Group 2 - The company employs technology to enhance workflows and has a forward-looking approach to technology adoption [4] - Proactive utilizes automation and software tools, including generative AI, while ensuring all content is edited and authored by humans [5]

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]

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]

Core Viewpoint - OKYO Pharma Limited is advancing its lead clinical drug candidate, urcosimod, for the treatment of neuropathic corneal pain, a condition currently lacking FDA-approved therapies, and will present its development at an upcoming summit [1][2]. 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 [4]. Presentation Details - Dr. Gary S. Jacob, CEO of OKYO Pharma, will present on May 22, 2025, at the 4th Annual GPCRs-Targeted Drug Discovery Summit in Boston, MA, discussing the clinical development of urcosimod targeting CMKLR1 (ChemR23) for neuropathic corneal pain [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, and is currently treated with limited success through off-label topical and systemic treatments [2]. Urcosimod Development - Urcosimod, a lipid-conjugated chemerin peptide agonist, is designed to enhance the residence time in the ocular environment and has shown anti-inflammatory and pain-reducing effects in preclinical models [3]. - The drug has demonstrated statistical significance in multiple endpoints in a Phase 2 trial for dry eye disease and is currently being evaluated in a Phase 2 trial for neuropathic corneal pain [3].