FDA Grants Fast Track Designation to OKYO Pharma’s Urcosimod for Neuropathic Corneal Pain

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to OKYO Pharma for its investigational candidate urcosimod, intended for the treatment of neuropathic corneal pain (NCP). NCP is a rare and severely painful condition affecting the eyes, face, or head, believed to result from nerve damage in the cornea combined with inflammation. Currently, there are no FDA-approved treatments for this condition.

Regulatory Pathway Enhanced for Accelerated Development

OKYO Pharma had submitted its Fast Track application in March 2025. With the designation now granted, the company gains access to:

       • More frequent interactions with the FDA to align trial design and data collection

       • Eligibility for rolling review, allowing sections of the new drug application (NDA) to be submitted and reviewed on an ongoing basis

This designation is intended to accelerate the development timeline and facilitate earlier access to patients in need.

CEO Statement on FDA Milestone

Gary S. Jacob, PhD, CEO of OKYO Pharma, commented on the FDA’s decision in a recent company press release:

“We are thrilled with the FDA’s Fast Track designation for urcosimod in the treatment of neuropathic corneal pain. This milestone underscores our commitment to advancing innovative therapies that can make a meaningful difference in patients’ lives. We look forward to working closely with the FDA to bring this promising treatment to patients as quickly as possible.”

Urcosimod: Novel Mechanism Targeting ChemR23 Pathways

Urcosimod is described by OKYO Pharma as a lipid-conjugated chemerin peptide agonist of the ChemR23 G-protein-coupled receptor (GPCR). This receptor is expressed on:

       • Immune cells in the eye responsible for mediating inflammatory responses

       • Neurons and glial cells in the dorsal root ganglion associated with sensory processing

The dual presence of ChemR23 in both inflammatory and sensory pathways highlights urcosimod’s potential to address both pain and inflammation in NCP.

Long-Term Stability and Clinical Trial Progress

OKYO Pharma recently announced positive long-term stability data for urcosimod, confirming the drug’s stability for over 2.5 years in single-use ampoules used for patient administration.

Urcosimod is currently being evaluated in a Phase 2b clinical trial:

       • Randomized, placebo-controlled, and double-masked

       • Enrolling 48 patients with NCP  

       • First patient was dosed in October 2024

This study aims to further assess the safety and efficacy of urcosimod in treating this high-unmet-need condition.