FDA Confirms Pivotal Trial Design for Neuropathic Corneal Pain Drug Urcosimod

summarizeSummary

OKYO Pharma announced a successful Type C meeting with the FDA, securing alignment on the Phase 2b/3 clinical trial design for urcosimod, its lead candidate for neuropathic corneal pain.

check_boxKey Events

• FDA Alignment on Phase 2b/3 Trial Design

  OKYO Pharma held a successful Type C meeting with the FDA, confirming the design for the Phase 2b/3 clinical trial of urcosimod for neuropathic corneal pain (NCP).

• Key Trial Parameters Endorsed

  The FDA endorsed the proposed primary endpoint (Visual Analogue Scale pain reduction at Week 12, with ≥2-point improvement as meaningful), sample size, powering assumptions, and the use of the Ocular Pain Assessment Survey (OPAS) as supportive evidence.

• Regulatory Pathway De-risked

  The FDA's alignment on the clinical development program and Chemistry, Manufacturing and Controls (CMC) strategy significantly de-risks the pathway to a pivotal trial and potential registration, as stated by company leadership.

• Trial Initiation Expected H1 2026

  The company expects to initiate the 120-patient Phase 2b/3 multiple-dose study of urcosimod in the first half of 2026.

auto_awesomeAnalysis

OKYO Pharma's successful Type C meeting with the FDA significantly de-risks the clinical development program for urcosimod, its lead candidate for neuropathic corneal pain. The FDA's explicit confirmation of the Phase 2b/3 trial design, including the primary endpoint, sample size, and statistical approach, provides a clear regulatory pathway forward. This alignment is a crucial step for a clinical-stage biopharmaceutical company, reducing uncertainty and bolstering confidence as the company prepares to initiate the pivotal 120-patient study in the first half of 2026. This positive regulatory clarity follows the recent FDA authorization for expanded access IND for urcosimod on January 23, 2026.