FDA Clears Breakthrough Access Pathway for Neuropathic Corneal Pain: OKYO's Urcosimod Gets Compassionate Use Approval

A major regulatory milestone in neuropathic corneal pain treatment has just materialized. OKYO Pharma Limited announced that the U.S. FDA has granted a single-patient expanded access authorization for Urcosimod 0.05%, marking a significant moment for patients suffering from this debilitating condition. The request came from Dr. Pedram Hamrah at the University of South Florida on behalf of a patient with severe neuropathic corneal pain who had exhausted all conventional treatment alternatives.

The Unmet Medical Crisis: Why Neuropathic Corneal Pain Demands Urgent Solutions

Neuropathic corneal pain represents one of medicine’s most challenging conditions—a chronic disorder characterized by severe nerve dysfunction and corneal inflammation. What makes this particularly concerning is the treatment vacuum: currently, no FDA-approved medications specifically target this condition. Patients desperate for relief are forced to rely on off-label treatments that typically deliver minimal therapeutic benefit. The authorization of Urcosimod represents a potential turning point for this neglected patient population.

Urcosimod’s Revolutionary Approach: Targeting Both Inflammation and Nerve-Related Pain Signaling

The drug’s scientific foundation appears particularly promising. Urcosimod (formerly designated as OK-101) employs a sophisticated dual mechanism—simultaneously tackling inflammatory pathways while interrupting the nerve-related pain signaling cascade that defines neuropathic corneal pain. Preclinical research demonstrated compelling anti-inflammatory and pain-reducing activity, and more recently, a randomized Phase 2 trial in neuropathic corneal pain patients delivered positive efficacy results. These cumulative data points have justified FDA’s decision to expand access for this compassionate-use case.

Clinical Pipeline Accelerates as OKYO Advances to Late-Stage Development

The regulatory approval reflects growing confidence in Urcosimod’s potential. OKYO has signaled plans to launch a 120-patient Phase 2b/3 multiple-dose study before year-end 2026, which could represent a decisive step toward conventional FDA approval and broader patient access. This accelerated timeline underscores industry expectations surrounding the drug candidate.

Market Reaction and Stock Performance Indicates Investor Optimism

From a market quotes perspective, OKYO shares have demonstrated notable volatility, trading between $0.90 and $3.34 over the preceding twelve months. At the time of this regulatory announcement, the stock closed at $2.37, representing a 13.94% daily gain, with pre-market trading reaching $2.43 (+2.53%). The upward momentum reflects investor recognition that FDA compassionate use authorization—while limited in immediate commercial scope—validates the therapeutic approach and potentially accelerates the company’s path to broader pain relief solutions for neuropathic corneal pain patients.