LONDON and NEW YORK — January 28, 2026 — Leads & Copy — OKYO Pharma Limited (Nasdaq: OKYO) has announced the successful completion of a Type C meeting with the Food & Drug Administration (FDA) concerning the Phase 2b/3 human clinical trial of urcosimod for neuropathic corneal pain (NCP).
The FDA has confirmed that the proposed primary endpoint of the Visual Analogue Scale (VAS) pain reduction at Week 12 is clinically meaningful, explicitly acknowledging that a ≥2-point improvement on the VAS scale represents a meaningful treatment effect.
The Agency also 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.
Furthermore, the 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. The FDA also aligned on the Chemistry, Manufacturing and Controls (CMC) strategy and key clinical elements, with no material issues raised.
According to OKYO Pharma, this alignment derisks the pathway to a pivotal trial and supports potential registration if study results are robust.
Raj Patil, Ph.D., Chief Scientific Officer at OKYO Pharma, stated that the company was pleased to achieve meaningful progress with the FDA toward alignment on urcosimod’s clinical development program, underscoring the potential to address a significant unmet medical need in patients with neuropathic corneal pain.
Robert Dempsey, CEO of OKYO Pharma, thanked the OKYO team for their focus, rigor, and collaboration that led to this successful Type C meeting with the FDA. Dempsey added that the FDA’s alignment on their Phase 2b/3 strategy meaningfully de-risks the program and represents a meaningful value-inflection point for urcosimod, and a step forward for patients suffering from neuropathic corneal pain.
As previously communicated, urcosimod was granted the first IND to treat patients with NCP and was awarded fast track designation by the FDA. 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.
Neuropathic corneal pain (NCP) is a chronic condition characterized by severe pain and sensitivity of the eyes. It is thought to result from damage or dysfunction of corneal sensory nerves and may occur in patients with a range of underlying ophthalmic conditions. There are currently no FDA-approved therapies specifically for NCP.
Urcosimod is a lipid conjugated chemerin peptide agonist of the ChemR23 G-protein coupled receptor which is typically found on immune cells of the eye responsible for the inflammatory response, as well as on neurons and glial cells in the dorsal root ganglion. Urcosimod has been shown to produce anti-inflammatory and pain-reducing activities in a mouse model of dry eye disease and in a neuropathic corneal pain mouse model, respectively. OKYO recently announced positive data on NCP pain reduction in a randomized, placebo-controlled, double-masked Phase 2 trial involving 18 neuropathic corneal pain patients. Urcosimod showed clear statistical significance in multiple endpoints in an earlier 240-patient Phase 2, multi-center, double-masked, placebo-controlled trial to treat dry eye disease.
OKYO Pharma Limited is a clinical-stage biopharmaceutical company developing therapies for the treatment of neuropathic corneal pain (NCP) and inflammatory eye diseases. OKYO is focused on the discovery and development of novel molecules to treat neuropathic corneal pain and other ocular diseases. OKYO recently completed a successful phase 2 trial of its flagship drug urcosimod in patients with NCP and plans to initiate a 120-patient Phase 2b/3 multiple-dose study of urcosimod to treat NCP in the first half of this year.
Source: OKYO Pharma
