OKYO Pharma Files for Fast Track Designation with FDA for Urcosimod to Treat Neuropathic Corneal Pain
March 10, 2025 – Clinical Trials, Drug Discovery, Other, Pharmaceutical – FDA, OKYO Pharma, clinical trials, dry eye disease, fast track designation, neuropathic corneal pain
10 March 2025 — London, UK and New York, US — OKYO Pharma Limited, 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) for the treatment of neuropathic corneal pain, which is a debilitating condition affecting many tens of thousands worldwide, and is characterized by chronic, severe eye discomfort for which there is no FDA-approved, effective treatment.
“Fast track was first introduced by FDA to expedite development and review of drugs to treat serious conditions lacking any FDA-approved drug,” commented Gary S. Jacob, Ph.D., Chief Executive Officer of OKYO Pharma. “Notably, neuropathic corneal pain falls into this category, and our application for Fast Track designation marks a significant milestone in our commitment to addressing the urgent needs of patients suffering from this type of pain. It is our belief that urcosimod has the potential to redefine the treatment paradigm for individuals grappling with this challenging condition.”
About FDA Fast Track Designation
At this stage of development, a drug that receives Fast Track designation is eligible for some or all of the following:
- More frequent meetings with FDA to discuss the drug’s development plan, ensure collection of appropriate data needed to support drug approval, plus the use of a rolling FDA review to expedite its regulatory path.
- Quicker turnaround on written communication from FDA regarding such things as the design of the proposed clinical trials and potential use of biomarkers.
For more information on fast track designation: https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track
About OKYO
OKYO Pharma Limited is a clinical stage biopharmaceutical company developing innovative therapies for the treatment of neuropathic corneal pain and dry eye disease, with ordinary shares listed for trading on the NASDAQ Capital Market. OKYO is focused on the discovery and development of novel molecules to treat neuropathic corneal pain and dry eye disease. In addition to the completed Phase 2 trial of urcosimod to treat dry eye disease patients, OKYO is also currently evaluating urcosimod to treat neuropathic corneal pain patients in a Phase 2 trial. For further information, please visit www.okyopharma.com.
