OKYO Pharma clears key FDA meeting for Urcosimod Phase 2b/3 Trial

OKYO Pharma’s new CEO Robert Dempsey joined Steve Darling from Proactive to announce that the company has completed a successful Type C meeting with the U.S. Food and Drug Administration regarding the planned Phase 2b/3 human clinical trial of urcosimod for the treatment of neuropathic corneal pain. Dempsey told Proactive that the FDA confirmed the company’s proposed primary efficacy endpoint—reduction in ocular pain as measured by the Visual Analogue Scale (VAS) at Week 12—is clinically meaningful. Importantly, the agency explicitly acknowledged that a reduction of at least two points on the VAS scale represents a meaningful treatment effect for patients suffering from this condition. In addition, the FDA provided statistical guidance aimed at strengthening the overall robustness of the trial. The agency noted that if the statistical analysis plan is finalized prior to unmasking and the study results are compelling, the data could potentially serve as substantial evidence of effectiveness at a future End-of-Phase 2b/3 meeting. The FDA also endorsed OKYO Pharma’s proposed study design, including sample size and powering assumptions, reinforcing confidence in the company’s clinical strategy. Furthermore, the agency agreed that the Ocular Pain Assessment Survey is appropriate as supportive quality-of-life evidence, complementing the primary endpoint. Dempsey added that the company is aligned with the FDA on its Chemistry, Manufacturing, and Controls (CMC) strategy, as well as other key clinical elements of the program. No material issues were raised during the meeting, which management believes significantly de-risks the regulatory pathway toward a pivotal trial and supports the potential for future registration, assuming the Phase 2b/3 study delivers robust clinical results. #proactiveinvestors #okyopharmalimited #nasdaq #okyo #Urcosimod #NeuropathicCornealPain #BiotechNews #ClinicalTrials #FDAapproval #FDAUpdate #ClinicalTrials #Phase2b3 #BiotechNews #DrugDevelopment #Ophthalmology #NeuropathicPain #CornealPain #Urcosimod #RegulatoryMilestone #LifeSciences #HealthcareInnovation