Neutral
GlobeNewsWire
7 days ago
OKYO Pharma Announces Successful Type C Meeting with the FDA
LONDON and NEW YORK, Jan. 28, 2026 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (Nasdaq: OKYO), a clinical-stage biopharmaceutical company developing investigational therapies for the treatment of neuropathic corneal pain (NCP) and for inflammatory eye diseases, today announces that it held a successful Type C meeting with the Food & Drug Administration (FDA) regarding the Phase 2b/3 human clinical trial of urcosimod for the treatment of neuropathic corneal pain (NCP). Key highlights from the Type C FDA meeting include: FDA confirms the approach that the proposed primary endpoint of the Visual Analogue Scale (VAS) pain reduction at Week 12 is clinically meaningful, including explicit acknowledgment that a ≥2-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 (SAP) 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 (OPAS) is appropriate as supportive quality-of-life evidence FDA alignment on the Chemistry, Manufacturing and Controls (CMC) 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 “We were very pleased to achieve meaningful progress with the FDA toward alignment on urcosimod's clinical development program,” said Raj Patil, Ph.D.
