OKYO Pharma(OKYO)
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OKYO Pharma secures FDA fast-track designation for urcosimod for neuropathic corneal pain
Proactiveinvestors NA· 2025-05-01 12:36
Group 1 - Proactive provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The news team covers medium and small-cap markets, as well as blue-chip companies, commodities, and broader investment stories [3] - Proactive has bureaus and studios in key finance and investing hubs including London, New York, Toronto, Vancouver, Sydney, and Perth [2][3] Group 2 - The company is focused on sectors such as biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] - Proactive adopts technology to enhance workflows and improve content production [4] - Automation and software tools, including generative AI, are used, but all content is edited and authored by humans [5]
FDA Grants OKYO Pharma Fast Track Designation to Urcosimod for Neuropathic Corneal Pain
Globenewswire· 2025-05-01 11:00
Core Viewpoint - OKYO Pharma Limited has received Fast Track designation from the FDA for urcosimod, aimed at treating neuropathic corneal pain (NCP), a condition currently lacking an FDA-approved therapy [1][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 the NASDAQ Capital Market [8]. Product Development - Urcosimod, previously known as OK-101, is being developed to address NCP, characterized by severe eye pain due to nerve damage [1][3]. - The Phase 2 trial for urcosimod is a double-masked, randomized, 12-week placebo-controlled study involving patients with confirmed NCP [6]. FDA Fast Track Designation - The Fast Track designation is intended to expedite the development and review of therapies for serious conditions, providing benefits such as more frequent FDA meetings and eligibility for Accelerated Approval [2]. - This designation highlights the urgent medical need for effective treatments for NCP, which is currently managed through off-label therapies [5]. Mechanism of Action - Urcosimod is a lipid-conjugated chemerin peptide agonist targeting the ChemR23 G-protein coupled receptor, involved in the inflammatory response and pain management [7]. - The drug has demonstrated anti-inflammatory and pain-reducing effects in preclinical models, with a design aimed at enhancing its residence time in the ocular environment [7].
OKYO Pharma accelerates clinical development of urcosimod for neuropathic corneal pain
Proactiveinvestors NA· 2025-04-30 14:02
Group 1 - Proactive provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The news team covers medium and small-cap markets, as well as blue-chip companies, commodities, and broader investment stories [3] - Proactive focuses on sectors such as biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] Group 2 - Proactive is committed to adopting technology to enhance workflows and content production [4] - The company utilizes automation and software tools, including generative AI, while ensuring all content is edited and authored by humans [5]
OKYO Pharma Announces Plans to Accelerate the Clinical Development of Urcosimod to Treat Neuropathic Corneal Pain
GlobeNewswire News Room· 2025-04-30 11:00
Core Viewpoint - OKYO Pharma Limited is accelerating the clinical development of urcosimod for treating neuropathic corneal pain (NCP) following the early closure of its Phase 2 trial, which involved 17 patients [1][2][4]. Group 1: Clinical Trial Details - The Phase 2 trial was conducted at Tufts Medical Center in Boston, MA, and was designed as a double-masked, randomized, 12-week placebo-controlled study [2][6][8]. - The trial was closed early to access masked data and plan for an expanded multicenter trial, as significant interest has been shown by potential patients [2][4]. - A total of 48 patients were initially planned for enrollment, with NCP confirmed via confocal microscopy [6]. Group 2: Drug Information - Urcosimod, previously known as OK-101, is a lipid-conjugated chemerin peptide agonist targeting the ChemR23 receptor, involved in the inflammatory response and pain [7]. - The drug has demonstrated favorable safety and tolerability in a previous Phase 2 trial involving 240 patients [4][7]. - Urcosimod has shown anti-inflammatory and pain-reducing effects in preclinical models and is designed to enhance its residence time in the ocular environment [7]. Group 3: Future Plans - The company plans to analyze the efficacy data from the 17 patients who completed the trial and aims to meet with the FDA to discuss further development [4][8]. - There is a strong interest from patients for continued compassionate use of urcosimod, which the company is seeking to arrange [3].
OKYO Pharma reports long-term shelf stability of corneal pain treatment
Proactiveinvestors NA· 2025-03-31 12:49
Use of technology Proactive has always been a forward looking and enthusiastic technology adopter. Proactive financial news and online broadcast teams provide fast, accessible, informative and actionable business and finance news content to a global investment audience. All our content is produced independently by our experienced and qualified teams of news journalists. Proactive news team spans the world's key finance and investing hubs with bureaus and studios in London, New York, Toronto, Vancouver, Sydn ...
OKYO Pharma(OKYO) - 2025 Q4 - Annual Report
2025-03-31 12:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 March 2025 Commission File Number: 001-41386 OKYO Pharma LTD (Exact Name of Registrant as Specified in Its Charter) 9Floor 107 Cheapside London EC2V 6DN (Address of registrant's principal executive office) Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40- ...
OKYO Pharma Announces Positive Data in Long-Term Stability of Urcosimod
Newsfilter· 2025-03-31 12:00
Core Insights - OKYO Pharma Limited is developing urcosimod for treating neuropathic corneal pain (NCP) and inflammatory dry eye disease (DED), with the latter being a multi-billion-dollar market [1][8] - Urcosimod has demonstrated stability for over two and a half years in single-use ampoules, which is crucial for FDA approval [1][6] - The company is currently conducting a Phase 2b clinical trial for urcosimod in NCP patients, involving 48 participants [3][7] Company Overview - OKYO Pharma Limited is a clinical-stage biopharmaceutical company focused on innovative therapies for NCP and DED, with shares traded on NASDAQ [8] - The company emphasizes the importance of chemistry, manufacturing, and controls (CMC) in drug approval processes, particularly regarding shelf stability [2] Clinical Development - The Phase 2b trial for urcosimod is a double-masked, randomized, placebo-controlled study, confirming NCP through confocal microscopy [3] - Urcosimod is administered as eye drops, and its stability and efficacy have been positively received in earlier trials for DED [2][5] Drug Characteristics - Urcosimod is a lipid-conjugated chemerin peptide agonist targeting the ChemR23 receptor, designed to provide long-lasting effects in treating dry eye disease and corneal neuropathic pain [5] - The drug has shown anti-inflammatory and pain-reducing activities in preclinical models, enhancing its potential for clinical use [5]
OKYO Pharma Files for Fast Track Designation with FDA for Urcosimod to Treat Neuropathic Corneal Pain
Globenewswire· 2025-03-10 12:30
LONDON and NEW YORK, March 10, 2025 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (NASDAQ: OKYO), a clinical-stage biopharmaceutical company developing innovative therapies for the treatment of neuropathic corneal pain, a severe ocular condition without an FDA approved therapy, and for inflammatory dry eye disease, a multi-billion-dollar market, is pleased to announce the filing of its application for Fast Track designation with the U.S. Food and Drug Administration (FDA) for urcosimod (formerly known as OK-101) ...
OKYO Pharma Announces OK-101 Officially Assigned USAN : Urcosimod
Globenewswire· 2025-02-12 12:00
LONDON and NEW YORK, Feb. 12, 2025 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (NASDAQ: OKYO), a clinical-stage biopharmaceutical company developing innovative therapies for the treatment of neuropathic corneal pain (NCP), a severe ocular condition without an FDA approved therapy, and for inflammatory dry eye disease (DED), a multi-billion-dollar market, is pleased to announce that its lead asset, OK-101, has been officially assigned the United States Adopted Name (USAN) "urcosimod". The USAN designation reflec ...
OKYO Pharma poised for multi-billion-dollar opportunity in ocular treatment market, analysts believe
Proactiveinvestors NA· 2025-01-31 17:46
About this content About Emily Jarvie Emily began her career as a political journalist for Australian Community Media in Hobart, Tasmania. After she relocated to Toronto, Canada, she reported on business, legal, and scientific developments in the emerging psychedelics sector before joining Proactive in 2022. She brings a strong journalism background with her work featured in newspapers, magazines, and digital publications across Australia, Europe, and North America, including The Examiner, The Advocate, ...