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]

Core Viewpoint - OKYO Pharma Limited announces the appointment of Robert J. Dempsey as Chief Executive Officer, transitioning Gary S. Jacob, Ph.D. to Chief Development Officer, to ensure continuity and advance the company's strategic direction in developing therapies for neuropathic corneal pain and inflammatory eye diseases [1][3][4]. Company Overview - OKYO Pharma is a clinical-stage biopharmaceutical company focused on innovative therapies for neuropathic corneal pain (NCP) and inflammatory eye diseases, with shares traded on NASDAQ [15]. - The company has recently completed a successful Phase 2 trial of its lead drug, urcosimod, in patients with NCP and is planning a larger multicenter trial set to begin in Q1 2026 [15]. Leadership Transition - Robert J. Dempsey brings over 20 years of global ophthalmology experience, including significant roles in drug development and commercialization, previously serving as Group Vice President and Head of Global Ophthalmology at Shire [2][5]. - Dempsey's experience includes leading the commercialization of Xiidra, a top-selling dry eye treatment, and he is expected to leverage this expertise to advance urcosimod [2][4][7]. - Gary S. Jacob, Ph.D. has been recognized for his leadership in shaping OKYO's clinical strategy and will continue to support the company as Chief Development Officer and Board member [4][13]. Product Focus - Urcosimod, the company's lead asset, is a lipid conjugated chemerin peptide agonist that has shown anti-inflammatory and pain-reducing effects in preclinical models [10]. - The drug has demonstrated statistical significance in multiple endpoints in a Phase 2 trial for dry eye disease and has recently shown positive data for pain reduction in NCP patients [14]. Market Context - Neuropathic corneal pain is a severe condition currently lacking FDA-approved therapies, with existing treatments providing limited success [9]. - The transition in leadership and the focus on advancing urcosimod position OKYO Pharma to address significant unmet needs in this market [3][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 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]

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]