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
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, ...
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
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, ...
OKYO Pharma Announces Plans to Accelerate the Clinical Development of Urcosimod to Treat Neuropathic Corneal Pain
GlobeNewswire News Room· 2025-04-30 11:00
Urcosimod phase 2 trial treating Neuropathic Corneal Pain (“NCP”) patients was initiated in October 2024 and designed as a double-masked, randomized, 12-week placebo-controlled trial.OKYO Pharma plans to analyze the efficacy data from the 17 patients who have now completed the Phase 2 trial.OKYO Pharma plans for a meeting with FDA following evaluation of clinical data. LONDON and NEW YORK, April 30, 2025 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (NASDAQ: OKYO), an ophthalmology-focused bio-pharmaceutical comp ...
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 Announces Positive Data in Long-Term Stability of Urcosimod
Newsfilter· 2025-03-31 12:00
LONDON and NEW YORK, March 31, 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 the Company has successfully established that urcosimod (formerly known as OK-101) has been shown to be stable for over two and a h ...
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, ...
OKYO Pharma insiders acquire shares
Proactiveinvestors NA· 2025-01-31 14:25
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, ...