OKYO Pharma Limited announced the filing of its application for Fast Track designation with the FDA for urcosimod for the treatment of neuropathic corneal pain, a severe ocular condition without an FDA-approved therapy. 

Urcosimod (formerly called OK-101) is a lipid conjugated chemerin peptide agonist of the ChemR23 G-protein coupled receptor, which is typically found on immune cells of the eye responsible for the inflammatory response, as well as on neurons and glial cells in the dorsal root ganglion, according to an OKYO Pharma press release. It was developed using a membrane-anchored-peptide technology to produce a novel long-acting drug candidate for treating dry eye disease. The company says that urcosimod has been shown to produce anti-inflammatory and pain-reducing activities in mouse models of dry eye disease and corneal neuropathic pain, respectively, and is designed to combat washout through the inclusion of the lipid anchor built into the drug molecule to potentially enhance the residence time of the treatment within the ocular environment.

In a recently completed phase 2, multi-center, double-masked, placebo-controlled trial to treat dry eye disease urcosimod showed clear statistical significance in multiple endpoints. It is currently in a randomized, placebo-controlled, double-masked phase 2 trial to treat 48 neuropathic corneal pain patients.