On January 23, 2026, OKYO Pharma Limited (Nasdaq: OKYO), a clinical-stage biopharmaceutical company focused on therapies for neuropathic corneal pain (NCP) and inflammatory eye diseases, announced that the U.S. Food and Drug Administration (FDA) has authorized a single-patient expanded access Investigational New Drug (IND 176297) application—commonly known as compassionate use—for urcosimod (0.05%). The IND was submitted by Pedram Hamrah, MD, at the University of South Florida, to treat a patient suffering from severe NCP who has exhausted available therapeutic options, with no FDA-approved treatments currently existing for this condition.
NCP is a chronic, often debilitating ocular disorder characterized by persistent severe eye pain, light sensitivity, and sometimes facial or head pain, stemming from corneal sensory nerve damage or dysfunction combined with inflammatory processes. Patients frequently rely on off-label therapies that provide limited relief.
Urcosimod (formerly OK-101) is a novel lipid-conjugated chemerin peptide agonist of the ChemR23 (CMKLR1) G-protein coupled receptor, expressed on immune cells in the eye and neurons/glial cells in the dorsal root ganglion. It exhibits a dual mechanism: reducing immune-mediated inflammation and modulating neuropathic pain signaling. Preclinical models demonstrated anti-inflammatory and pain-reducing effects in dry eye disease and NCP. Clinically, urcosimod achieved positive outcomes in a recent randomized, placebo-controlled, double-masked Phase 2 trial involving 18 NCP patients, with statistically significant pain reduction. It also showed efficacy in an earlier 240-patient Phase 2 trial for dry eye disease.
The FDA previously granted urcosimod Fast Track designation and the first IND for NCP treatment. Dr. Hamrah noted the strong scientific rationale for urcosimod’s dual action in addressing both inflammatory and neuropathic pathways. CEO Robert J. Dempsey highlighted the authorization as underscoring the urgent global need for innovative NCP therapies and offering hope to patients with this painful, untreated condition. OKYO Pharma will supply urcosimod for this compassionate use. The company anticipates initiating a 120-patient Phase 2b/3 multiple-dose study for NCP later in 2026, advancing toward potential broader approval for this unmet medical need.
