OKYO Pharma Ltd Receives FDA Fast Track Designation for Urcosimod in Neuropathic Corneal Pain Treatment

LONDON and NEW YORK, May 01, 2025 — OKYO Pharma Limited (NASDAQ: OKYO), a London-based biopharmaceutical company specializing in ophthalmology, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its investigational drug urcosimod (formerly known as OK-101) for the treatment of neuropathic corneal pain (NCP). This designation is a significant milestone for OKYO Pharma, as it aims to expedite the development and review process for therapies addressing serious conditions with unmet medical needs.

Neuropathic corneal pain is a chronic and often severe ocular condition that currently lacks an FDA-approved therapy. OKYO Pharma’s urcosimod is being developed to alleviate the symptoms associated with this condition, potentially improving the quality of life for affected patients worldwide.

The Fast Track designation by the FDA is intended to facilitate the development and expedite the review of drugs that treat serious conditions and fulfill unmet medical needs. This designation allows for more frequent interactions with the FDA, including the possibility of rolling reviews and priority review, which can significantly shorten the time required to bring a new therapy to market.

In addition to the Fast Track designation, OKYO Pharma has been actively advancing the clinical development of urcosimod. The company initiated a Phase 2 trial in October 2024, designed as a double-masked, randomized, 12-week placebo-controlled trial. The trial aims to evaluate the efficacy of urcosimod in treating NCP. As of April 30, 2025, 17 patients have completed the trial, and OKYO Pharma plans to analyze the efficacy data from these participants.

Following the evaluation of the clinical data, OKYO Pharma intends to meet with the FDA to discuss the findings and the next steps in the development process. This proactive approach underscores the company’s commitment to advancing its pipeline and addressing the needs of patients suffering from neuropathic corneal pain.

OKYO Pharma, listed on the Nasdaq stock exchange, has a market capitalization of $39,620,000 as of April 29, 2025. Despite a negative price-to-earnings ratio of -2.41, the company’s recent developments and strategic focus on innovative therapies in the biotechnology sector position it as a noteworthy player in the healthcare industry.

For more information about OKYO Pharma and its ongoing projects, interested parties can visit the company’s website at www.okyopharma.com .