OKYO Pharma Reports New Phase 2 Findings Showing Urcosimod 0.05% Reduces Pain And Improves Corneal Nerve Structure In Patients With Neuropathic Corneal Pain

OKYO Pharma Limited, a clinical-stage biopharmaceutical company developing therapies for neuropathic corneal pain (NCP)—a severe eye condition with no FDA-approved treatments—has released new findings from detailed corneal image analyses conducted as part of its recently completed Phase 2 clinical trial of urcosimod. This placebo-controlled, randomized, double-masked study evaluated urcosimod in patients with NCP and showed that those treated with the 0.05% formulation experienced not only a meaningful reduction in pain, but also positive changes in the structure of corneal nerves. These structural improvements were not seen in the placebo group.

The new data comes from exploratory nerve growth analyses included in the 18-patient trial. Patients receiving 0.05% urcosimod showed promising improvements in several key measures of corneal nerve health. Median increases were observed in total nerve fiber count (+2.0 per 0.16 mm², IQR 0.54 to 3.63) and total nerve fiber length (+2.6 mm/mm², IQR 1.55 to 5.67; p = 0.057 compared to placebo). By contrast, patients in the placebo group showed median decreases in nerve fiber count (–1.92 per 0.16 mm², IQR –2.79 to –0.04) and nerve fiber length (–1.63 mm/mm², IQR –3.76 to 0.63). 

These exploratory findings, based on a subset of four patients per group, demonstrate consistent and meaningful improvements across multiple nerve-related anatomical endpoints for those treated with urcosimod. This strengthens the evidence that urcosimod may help restore corneal nerve integrity, supporting its potential as a first-in-class treatment for neuropathic corneal pain.

(IQR refers to Interquartile Range.)

Pedram Hamrah, MD, FARVO, the trial’s Principal Investigator and a Professor of Ophthalmology at the University of South Florida, noted that these early signs of nerve regeneration are both encouraging and biologically significant. He emphasized that the consistent improvements seen across nerve fiber count and length suggest that urcosimod may not only help reduce patients’ pain symptoms but also contribute to rebuilding the corneal nerve network. Dr. Hamrah added that these findings are an important step in expanding the understanding of how urcosimod may work in treating neuropathic corneal pain and support further clinical investigation.