FDA Approves Fast Track for OKYO's Urcosimod in Neuropathic Corneal Pain

On May 1, 2025, OKYO Pharma Limited, a biopharmaceutical company specializing in ophthalmology, announced that its experimental treatment, urcosimod, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for treating neuropathic corneal pain (NCP). This condition is known for causing intense and chronic eye pain due to nerve damage, and currently, there are no FDA-approved treatments available. The Fast Track status aims to speed up the development and review process of new therapies that address serious medical conditions with unmet needs, thereby providing patients with earlier access to potential treatments.

Fast Track designation offers several advantages, such as increased opportunities for communication with the FDA to discuss the drug’s development strategy, the possibility of Accelerated Approval and Priority Review if specific criteria are met, and the option of a Rolling Review of the New Drug Application (NDA). These provisions are designed to expedite the availability of promising new medications to patients in need.

Neuropathic corneal pain is a severe and chronic condition that affects the eyes, causing significant discomfort and sensitivity. The disorder is believed to result from nerve damage in the cornea, often accompanied by inflammation. Current treatments are off-label, involving a mix of topical and systemic therapies, but none have received FDA approval. OKYO Pharma's urcosimod, also known as a lipid-conjugated chemerin peptide agonist, targets the ChemR23 G-protein coupled receptor found in immune cells of the eye and neurons, offering an innovative approach to this challenging condition.

The development of urcosimod includes the use of a membrane-anchored-peptide technology, intended to create a long-acting treatment option for both dry eye disease and neuropathic corneal pain. Studies in mouse models have shown that urcosimod can reduce inflammation and alleviate pain. A recently completed Phase 2 trial for dry eye disease demonstrated significant results in various endpoints, and urcosimod is also being investigated in a Phase 2 trial for NCP with a similar double-masked, placebo-controlled design.

Gary S. Jacob, Ph.D., the CEO of OKYO Pharma, expressed the company's excitement over the FDA's decision, stating that this designation highlights their dedication to developing innovative therapies that can significantly benefit patients. He emphasized the company's commitment to working closely with the FDA to make this promising treatment available as soon as possible.

OKYO Pharma Limited, listed on the NASDAQ Capital Market, is at the clinical stage of developing treatments for neuropathic corneal pain and dry eye disease. The company is dedicated to discovering and developing novel compounds to address these ophthalmic conditions. In addition to the completed Phase 2 trial for dry eye disease, OKYO continues to evaluate urcosimod for neuropathic corneal pain through ongoing clinical trials.