Urcosimod (OK-101) - (NEPTUNE)

Oct. 6, 2026: OKYO Pharma Limited (Nasdaq: OKYO) announced first-patient enrollment in the Phase 3 NEPTUNE registrational trial of urcosimod for neuropathic corneal pain (NCP), with the first patients enrolled by Dr. Melissa Toyos at Toyos Clinic in Nashville, Tennessee.

NEPTUNE is evaluating urcosimod as a potential first-in-class treatment for NCP, a chronic debilitating condition with no FDA-approved therapies, according to the company. The multicenter study is being initiated in the U.S., with planned enrollment across sites in the U.S. and Europe, including Italy, Spain, and France.

Patients will receive four drops daily for 12 weeks. The primary endpoint is change from baseline to end of treatment in ocular pain measured by VAS score. Additional endpoints include quality-of-life scores and in-vivo confocal microscopy findings. The company said the trial is designed as a registrational study in accordance with FDA guidance.

The release identifies urcosimod as OKYO’s lead candidate. Clinical trial identifier provided: NCT07838506.