Okyo Pharma has officially submitted an application to the U.S. Food and Drug Administration (FDA) seeking Fast Track designation for its investigational drug, urcosimod (formerly OK-101), in the treatment of neuropathic corneal pain (NCP). The company is aiming to expedite the development and approval process for this promising therapy.
Gary S. Jacob, PhD, CEO of Okyo Pharma, emphasized the significance of the application, noting that Fast Track designation was introduced by the FDA to accelerate the development and review of drugs addressing serious conditions that currently lack approved treatments. “Neuropathic corneal pain falls into this category, and our application for Fast Track designation represents a major milestone in our commitment to providing relief for patients suffering from this debilitating condition,” said Jacob. “We believe that urcosimod has the potential to transform the treatment landscape for individuals facing this challenging condition.”
The Fast Track designation would allow Okyo Pharma to engage in more frequent discussions with the FDA regarding the drug’s development plan, ensuring the collection of the necessary data to support its approval. Additionally, it provides the opportunity for a rolling review by the FDA, which can speed up the regulatory process.
NCP is a painful condition that causes extreme sensitivity in the eyes, face, or head. While the exact cause remains unclear, it is generally thought to result from nerve damage to the cornea combined with inflammation. Currently, no FDA-approved drug exists to treat this condition.
Urcosimod, a lipid-conjugated chemerin peptide agonist targeting the ChemR23 G-protein coupled receptor, which plays a role in immune cell activity in the eye, has shown promising results. In a recently concluded Phase 2, multi-center, double-masked, placebo-controlled trial for dry eye disease, the drug demonstrated clear statistical significance across several endpoints. Okyo is currently conducting a Phase 2 trial to assess urcosimod’s efficacy in treating 48 patients with NCP.
The company also recently revealed that urcosimod’s official United States Adopted Name (USAN) is now finalized. The drug’s suffix, “-mod,” reflects its classification as a modulator of key inflammatory and neuropathic pathways, essential for addressing eye conditions such as neuropathic corneal pain and dry eye disease.
Related topic:
HMC Highlights Glaucoma Awareness During World Glaucoma Week
FDA Approves Gene Therapy for Eye Disease and Expands Nasal Spray
Genetic Test Offers Early Glaucoma Detection
