LONDON and NEW YORK, Feb. 23, 2026 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (Nasdaq: OKYO), a clinical-stage biopharmaceutical company developing investigational therapies for the treatment of neuropathic corneal pain (NCP) and for inflammatory eye diseases, today announced that its abstract has been accepted for presentation at the Association for Research in Vision and Ophthalmology (ARVO) 2026 Annual Meeting, taking place May 3-7, 2026, in Denver, Colorado. Chief Scientific Officer Raj Patil, Ph.D., will ...

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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]

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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].