OKYO Pharma Secures FDA Alignment on Urcosimod Trial Design for Neuropathic Corneal Pain

Event summary

  • OKYO Pharma held a successful Type C meeting with the FDA on January 28, 2026, regarding its Phase 2b/3 trial of urcosimod for neuropathic corneal pain (NCP).
  • FDA confirmed that a ≥2-point improvement on the Visual Analogue Scale (VAS) pain reduction at Week 12 is clinically meaningful.
  • The agency endorsed the proposed study design, sample size, and statistical guidance, reducing risks for a pivotal trial.
  • Urcosimod was previously granted fast track designation by the FDA and is set to begin a 120-patient Phase 2b/3 study in early 2026.

The big picture

OKYO Pharma’s alignment with the FDA on urcosimod’s clinical development marks a critical milestone in addressing neuropathic corneal pain, a condition with no approved treatments. The FDA’s endorsement of the trial design and endpoints reduces regulatory risk and positions OKYO to potentially capture a significant share of the NCP market, which remains a high-unmet medical need. The company’s fast-track designation further underscores the urgency and potential of urcosimod in this space.

What we're watching

Regulatory Clarity
How the FDA’s endorsement of the trial design will accelerate OKYO’s path to potential registration for urcosimod.
Clinical Execution
Whether the Phase 2b/3 trial can replicate earlier positive results and meet the FDA’s statistical robustness criteria.
Market Differentiation
The pace at which OKYO can establish urcosimod as a leading therapy in the underserved NCP market.