OKYO Pharma Holds Meeting with FDA, Confirms Urcosimod Clinical Trial Plan

OKYO Pharma held a Type C meeting with the Food & Drug Administration regarding the Phase 2b/3 human clinical trial of urcosimod for the treatment of neuropathic corneal pain. Key highlights from the Type C FDA meeting include: FDA confirms the approach that the proposed primary endpoint of the Visual Analogue Scale pain reduction at Week 12 is clinically meaningful, including explicit acknowledgment that a greater than or equal to2-point improvement on the VAS scale represents a meaningful treatment effect. The Agency provided statistical guidance to enhance robustness, noting that if the statistical analysis plan is finalized prior to unmasking and results are strong, the data could provide substantial evidence of effectiveness at a future End-of-Phase 2b/3 meeting. FDA endorsed the proposed study design, sample size, and powering assumptions, and agreed that the Ocular Pain Assessment Survey is appropriate as supportive quality-of-life evidence. FDA alignment on the Chemistry, Manufacturing and Controls strategy and key clinical elements, with no material issues raised, derisking the pathway to a pivotal trial and supports potential registration if study results are robust. As previously communicated, urcosimod was granted the first IND to treat patients with NCP and was awarded fast track designation by the Food and Drug Administration. The company expects to initiate a 120-patient Phase 2b/3 multiple-dose study of urcosimod to treat NCP in the first half of this year.