OKYO Pharma announced that following a productive Type C meeting with the US Food and Drug Administration, it has received clearance to initiate a combined Phase 2b/3 clinical trial of its lead candidate, urcosimod, in neuropathic corneal pain (NCP). CEO Robert Dempsey described the FDA discussion as providing “a clear line of sight” on the regulatory path, confirming the trial design, primary endpoints and safety requirements. The company plans to enroll approximately 150 patients across multiple centers in the United States, with a multiple–dose regimen to begin in the first half of 2026. NCP, a debilitating condition with no approved therapies, affects an estimated 200,000 patients annually in the US alone.

An abstract entitled “Evaluation of Urcosimod in Neuropathic Corneal Pain: Efficacy and Safety Results from a Proof-of-Concept Pilot Phase 2 Study” has been accepted for presentation at the 2026 American Society of Cataract and Refractive Surgery Annual Meeting. The proof-of-concept trial enrolled 18 NCP patients and demonstrated meaningful reductions in patient-reported pain scores versus placebo, along with trends toward improved corneal nerve density measured by in vivo confocal microscopy. Presentation is scheduled for April 11 in Washington, DC, during the Ocular Surface Disease II session. This selection follows a competitive review process, underscoring the potential of urcosimod as a first-in-class therapy for NCP and supporting the upcoming pivotal trial.