Okyo Pharma announces plans for next stage of development for urcosimod

OKYO Pharma (OKYO) announced plans for the next stage of clinical development for its lead drug candidate, urcosimod, to treat neuropathic corneal pain. The announcement follows the release in July of topline data from OKYO’s randomized, double-masked, placebo-controlled Phase 2 proof-of-concept trial of urcosimod in 17 NCP patients conducted at Tufts Medical Center in Boston, MA, with Pedram Hamrah, M.D., a world-leading expert in NCP, as Principle Investigator. After 12 weeks of treatment, 75% of per-protocol patients receiving 0.05% urcosimod showed greater than 80% reduction in neuropathic corneal pain in that study, as measured by visual analog scale, suggesting highly effective treatment in this patient population. Building on these promising results, OKYO is now focused on advancing to a multiple-ascending-dose clinical trial designed to: Enroll approximately 100 NCP patients across several U.S. clinical sites in this randomized, placebo-controlled, double-masked trial. Identify the optimal registration dose for urcosimod for future Phase 3 trials. Develop further understanding of urcosimod’s unique micellar drug characteristics. Negotiations with several leading U.S. clinical sites are underway, and OKYO anticipates topline data from this trial in 2026. As part of the registration pathway, OKYO continues to progress towards a meeting with the U.S. Food and Drug Administration to discuss requirements for an approvable drug to treat NCP and to define the primary endpoint required for potential registration. Urcosimod currently holds Fast-Track designation, which is expected to enable quick turn-around on having the meeting with the FDA.