OKYO Pharma files application for Fast Track designation with the FDA for urcosimod for the treatment of neuropathic corneal pain

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Okyo Pharma has filed an application for Fast Track designation with the US Food and Drug Administration (FDA) for urcosimod (formerly known as OK-101) for the treatment of neuropathic corneal pain (NCP).

Gary S. Jacob, PhD, CEO of Okyo Pharma commented on the application in a press release from the company.

“Fast track was first introduced by FDA to expedite development and review of drugs to treat serious conditions lacking any FDA-approved drug,” said Jacob. “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.”

Fast track designation allows for the company to have more frequent meetings with the FDA to discuss the drug’s development plan, ensure collection of appropriate data needed to support drug approval, as well as the use of a rolling FDA review to expedite its regulatory path

NCP is a condition that causes severe pain and sensitivity of the eyes, face, or head, and the exact cause is unknown, but is thought to result from nerve damage to the cornea combined with inflammation. There is currently no FDA-approved drug to treat NCP.

Urcosmid is a lipid conjugated chemerin peptide agonist of the ChemR23 G-protein coupled receptor, typically found on immune cells of the eye responsible for the inflammatory response. Urcosimod showed clear statistical significance in multiple endpoints in a recently completed Phase 2, multi-center, double-masked, placebo-controlled trial to treat dry eye disease, and is presently being evaluated in a randomized, placebo-controlled, double-masked Phase 2 trial to treat 48 neuropathic corneal pain patients.

Okyo recently announced the United States Adopted Name (USAN) of urcosmid, formally OK-101. According to the company, the suffix “-mod” in urcosimod denotes its classification as a modulator of key inflammatory and neuropathic pathways, critical to addressing ocular conditions such as neuropathic corneal pain and dry eye disease.

Reference:

1. OKYO Pharma files for Fast Track Designation with FDA for urcosimod to treat neuropathic corneal pain. Published March 10, 2025. Accessed March 10, 2025.https://ir.4dmoleculartherapeutics.com/news-releases/news-release-details/4dmt-announces-first-patients-enrolled-4front-1-phase-3-clinical