LONDON and NEW YORK — October 6, 2026
OKYO Pharma Limited announced that the first patients have been enrolled in the Phase 3 NEPTUNE clinical trial evaluating urcosimod as a potential treatment for neuropathic corneal pain (NCP). The first patients were enrolled by Dr. Melissa Toyos at Toyos Clinic in Nashville, Tennessee. The registrational study is designed to evaluate whether urcosimod can provide meaningful relief for patients with NCP, a debilitating condition for which there are currently no FDA-approved treatments.
Urcosimod Targets Inflammation and Ocular Pain
Urcosimod is OKYO’s lead investigational candidate and is designed as a lipid-conjugated chemerin peptide agonist of the ChemR23 G-protein-coupled receptor. ChemR23 is expressed on immune cells involved in the ocular inflammatory response as well as neurons and glial cells in the dorsal root ganglion. OKYO said urcosimod has demonstrated ocular analgesic and anti-inflammatory activity through its dual mechanism of action, supporting its development for neuropathic corneal pain and other anterior segment eye diseases.
NEPTUNE Evaluates Urcosimod in a Registrational Trial
The Phase 3 NEPTUNE study is being conducted across multiple clinical sites in the United States and Europe, including Italy, Spain and France. Patients will receive four drops of urcosimod per day for 12 weeks, with the primary efficacy endpoint measuring the change from baseline to the end of treatment in ocular pain using a visual analog scale (VAS). Additional endpoints include quality-of-life assessments and in-vivo confocal microscopy (IVCM) findings. The multicenter study has been designed as a registrational trial in accordance with FDA guidance.
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OKYO Advances Potential First Disease-Modifying Therapy for NCP
Neuropathic corneal pain is a chronic and often severe condition associated with damage or dysfunction of corneal sensory nerves and, in some cases, inflammatory processes. Patients can experience significant eye pain and sensitivity, sometimes extending to the face or head, even when clinical findings do not fully explain the severity of symptoms. With no FDA-approved therapy specifically available for NCP, OKYO is developing urcosimod as a potential first-in-class and disease-modifying treatment. The initiation of NEPTUNE and enrollment of the first patients marks a significant clinical development milestone as OKYO advances urcosimod toward potential regulatory evaluation for neuropathic corneal pain.
Source:: OKYO Pharma, press release
