OKYO Pharma Delivers Strong Phase 2 Results in Rare, Chronic Corneal Pain Condition

OKYO Pharma (Nasdaq: OKYO) announced encouraging top-line results from its Phase 2 trial evaluating urcosimod in patients with neuropathic corneal pain (NCP), a chronic and severely painful eye disorder that currently has no FDA-approved treatments.

The 12-week, placebo-controlled study showed that 75% of patients receiving 0.05% urcosimod experienced more than an 80% reduction in pain severity based on Visual Analogue Scale (VAS) scores. The effect was seen as early as week 4 and remained consistent throughout the trial. Statistically significant pain reductions were observed from baseline to study completion in this group, despite patients entering the trial with moderate to severe pain even after using multiple other therapies.

No serious adverse events were reported among the 18 patients enrolled, and the company plans to meet with the FDA to discuss next steps. Urcosimod has already received Fast Track designation for the treatment of NCP.

Neuropathic corneal pain is caused by damage to the nerves of the eye and often presents as intense, persistent pain without visible inflammation. Patients are typically left to manage symptoms with off-label treatments that may not provide lasting relief. OKYO is the first company to complete a clinical study in this underserved indication, positioning urcosimod as a potential first-in-class therapy.

“We are thrilled with these initial results,” said OKYO CEO Gary Jacob, adding that the drug may be especially effective in patients with more severe symptoms. OKYO also noted that some participants have requested access to urcosimod through the FDA’s Expanded Access program, reflecting patient interest in new treatment options.

The company intends to present a full data set after further analysis and will continue advancing urcosimod into future studies.