OKYO Pharma clears key FDA milestone, advances toward Phase 3 trial for Neuropathic corneal pain

OKYO Pharma’s CEO Robert Dempsey joined Steve Darling from Proactive to discuss positive feedback received from a U.S. Food and Drug Administration (FDA) Type D meeting, providing greater clarity on the regulatory pathway for urcosimod and supporting the company’s plans to advance the therapy into a global Phase 3 pivotal trial for neuropathic corneal pain (NCP). Dempsey said the FDA’s guidance validated the company’s updated regulatory strategy and reduced uncertainty surrounding the clinical development program. Based on discussions with the agency, OKYO is positioning its planned NEPTUNE Phase 3 trial as a pivotal study that could potentially support a single-trial registration strategy, subject to positive clinical results and continued FDA review. Urcosimod is the first investigational therapy with an active Investigational New Drug (IND) application specifically targeting neuropathic corneal pain and has received FDA Fast Track designation, recognizing the significant unmet medical need for a condition that currently has no approved treatments. Neuropathic corneal pain is a chronic and often debilitating disease characterized by severe eye pain and heightened sensitivity that can extend to the face and head. The condition is believed to result from damage or dysfunction of the corneal sensory nerves, often accompanied by inflammation, and patients frequently experience pain that is disproportionate to observable clinical findings. Dempsey said the positive FDA feedback strengthens the company’s confidence in its development plan and represents an important milestone as OKYO works to bring what could become the first approved therapy for neuropathic corneal pain to patients. #proactiveinvestors #okyopharmalimited #nasdaq #okyo #Urcosimod #NeuropathicCornealPain #HealthcareInnovation #ClinicalDevelopment #NeuroInflammation #CornealDisease #Pharmaceuticals #MedTech #DrugDevelopment #MartaSacchetti