OKYO Pharma Limited (OKYO) is up around 4% in pre-market trading after the company announced a successful Type C meeting with the U.S. FDA, securing alignment on the clinical development pathway for its lead candidate, Urcosimod, in neuropathic corneal pain.
OKYO is developing Urcosimod, a lipid-conjugated chemerin peptide agonist targeting the ChemR23 receptor, for the treatment of neuropathic corneal pain (NCP)- a debilitating ocular pain condition with no FDA-approved therapies. The company recently completed a positive Phase 2 trial showing statistically significant reductions in pain scores.
About Urcosimod
Urcosimod formerly OK-101, is designed to modulate inflammatory and neuronal pathways involved in corneal pain.
FDA Meeting Outcome
During the Type C meeting, the FDA:
•Confirmed the proposed primary endpoint - reduction in Visual Analogue Scale (VAS) pain at Week 12 - as clinically meaningful.
•Agreed that an improvement of two points or more on the VAS represents a meaningful treatment effect.
•Endorsed the Phase 2b/3 study design, including sample size, powering assumptions, and use of the Ocular Pain Assessment Survey (OPAS) as supportive evidence.
•Aligned on Chemistry, Manufacturing and Controls (CMC) strategy, raising no material issues.
•Indicated that if the statistical analysis plan is finalised prior to unmasking and results are strong, the data may support substantial evidence of effectiveness at a future End-of-Phase 2b/3 meeting.
The company plans to initiate a 120-patient Phase 2b/3 multiple-dose trial in the first half of 2026.
About Neuropathic Corneal Pain
NCP is a chronic, severe ocular pain condition caused by corneal nerve dysfunction. Patients often experience burning, stabbing, or electric-shock-like pain, with limited relief from existing off-label treatments. There are no approved therapies, making Urcosimod a potential first-in-class treatment.
OKYO has traded between $0.90 and $3.34 over the past year. The stock closed yesterday's trading at $2.13, down 1.39% and rose in the pre-market to $2.22, up 4.23%.
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