OKYO Pharma Ltd disclosed that its 18‑patient, double‑masked, placebo‑controlled Phase 2 study of urcosimod in neuropathic corneal pain (NCP) produced encouraging signals for corneal nerve regeneration. In the 0.05% urcosimod arm, in‑vivo confocal microscopy revealed increases in total nerve fiber count and length, while the placebo group showed declines in both metrics.
The exploratory endpoints were measured in a small, but rigorously designed trial that used in‑vivo confocal microscopy to quantify corneal nerve structure. The urcosimod group saw a measurable rise in nerve fiber count and length, whereas the placebo group experienced reductions, indicating a biologically meaningful effect. The p‑value for the primary nerve regeneration endpoint was 0.057, just above the conventional threshold for statistical significance, underscoring the exploratory nature of the findings.
Chief scientific officer Dr. Raj Patil said the data reinforce the company’s belief that targeting the chemerin receptor pathway can restore corneal nerve architecture and alleviate pain. Principal investigator Dr. Pedram Hamrah added that the consistent directional improvements across nerve fiber parameters suggest a meaningful therapeutic signal that warrants further investigation.
OKYO plans to launch a larger, multicenter Phase 2 trial in Q1 2026 to confirm these signals in a broader patient population. The company’s urcosimod program also received Fast Track designation from the FDA for NCP, a condition that currently has no FDA‑approved topical treatments, positioning OKYO ahead of competitors in this unmet‑need market.
The announcement was well received by investors, reflecting confidence in the drug’s potential to address a significant unmet medical need and to advance OKYO’s pipeline.
Urcosimod is a lipid‑conjugated chemerin peptide agonist of the ChemR23 G‑protein coupled receptor, previously demonstrating statistical significance in a 240‑patient Phase 2 trial for dry eye disease. The current NCP data add a critical milestone to OKYO’s development strategy and support the company’s focus on innovative ocular therapeutics.
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