FDA Endorses OKYO Pharma's Urcosimod Trial for Neuropathic Corneal Pain Treatment

OKYO Pharma has completed a successful Type C meeting with the FDA regarding the planned Phase 2b/3 trial of urcosimod for neuropathic corneal pain. The FDA confirmed the proposed primary efficacy endpoint and endorsed the study design, including sample size and powering assumptions. The agency also agreed that the Ocular Pain Assessment Survey is appropriate as supportive quality-of-life evidence. No material issues were raised during the meeting, significantly de-risking the regulatory pathway toward a pivotal trial.