OKYO Pharma Plans To Meet With FDA Following Completion Of Full Data Analysis For Urcosimod, Advancing Fast Track Path For NCP Treatment

Author: Benzinga Newsdesk | July 16, 2025 09:26am

• After 12 weeks of treatment, 75% of per-protocol patients receiving 0.05% urcosimod showed greater than 80% reduction in neuropathic corneal pain (NCP), as measured by Visual Analogue Scale (VAS), demonstrating highly effective treatment.
• Urcosimod (0.05%) demonstrated a marked reduction in pain scores as early as Week 4, with sustained efficacy maintained throughout the trial.
• A statistically significant reduction in mean pain scores was observed from Visit 1 to the end of treatment Visit 4 (p-value = 0.025) in the per-protocol 0.05% urcosimod group, indicating the drug's effectiveness over the study period.
• Notably, all these responders entered the study with moderate to severe NCP pain scores despite prior use of maximum medical therapy.
• No serious adverse events were reported among the 18 patients throughout the trial.
• Following completion of full data analysis, OKYO plans a meeting with FDA to discuss next steps for urcosimod which has already received Fast Track designation for treating NCP.

OKYO Pharma Limited (NASDAQ:OKYO), an ophthalmology-focused bio-pharmaceutical company which is developing urcosimod to treat neuropathic corneal pain (NCP), an ocular condition associated with chronic and often severe nerve-related pain but without an FDA-approved therapy, is pleased to announce positive top-line data from the recently closed 18-patient Phase 2 trial of urcosimod (formerly called OK-101) to treat NCP. OKYO is the first company to conduct a clinical study to treat NCP disease, a major unmet medical need.

This randomized, double-masked, placebo-controlled, Phase 2 Proof-of-Concept trial of urcosimod to treat NCP was conducted at a single trial site at Tufts Medical Center in Boston, MA, with Pedram Hamrah, M.D., a leading expert in NCP, as Principal Investigator.

Posted In: OKYO