Positive findings from phase 2a NCP on urcosimod include improved quality of life outcomes

OKYO Pharma announced new positive findings from an exploratory analysis of patient-reported outcomes in its recently completed Phase 2a trial of urcosimod (0.05%) for the treatment of neuropathic corneal pain (NCP).

The company describes urcosimod as a lipid-conjugated chemerin peptide agonist of the ChemR23 G-protein coupled receptor, which is typically found on immune cells of the eye responsible for the inflammatory response, as well as on neurons and glial cells in the dorsal root ganglion.

The phase 2 trial was a randomized, double-masked, placebo-controlled, proof-of-concept trial and was conducted at a single trial site at Tufts Medical Center in Boston, MA, with Pedram Hamrah, MD, a leading expert in NCP, as principal investigator. The trial was originally planned to enroll 48 patients. However, in April 2025, OKYO Pharma announced the decision to close the trial early, with 17 patients having completed the study due to a “strong desire to unmask the clinical data for an early read-out on a drug effect.”²

After 12 weeks of treatment, patients receiving urcosimod demonstrated greater improvements across key aspects of emotional well-being and quality of life (QoL) compared to placebo, as measured on a 0–10 scale.¹

QoL areas measured included enjoying relationships/life, overall mood, and time spent thinking of eye pain.

Patients reported a mean change from baseline of −4.5 (Interquartile Range [IQR] −6.00 to −0.75) for urcosimod vs. 0 (IQR −4.75 to 1.25) for placebo when asked about enjoying relationships with others and/or enjoying life. A mean change of −1.5 (IQR −5.25 to 0.25) for urcosimod vs. −0.5 (IQR −4.75 to 2.25) for placebo was reported when asked about overall mood. Finally, a mean change of −3.0 (IQR −5.00 to 0.00) for urcosimod vs. −1.5 (IQR −4.00 to 0.00) for placebo was recorded when asked about time spent thinking about eye pain.

The company stated that the QoL data may suggest that urcosimod may “provide broader therapeutic benefits, contributing to enhanced emotional well-being and overall day-to-day life satisfaction for patients suffering from this debilitating condition.”

Flavio Mantelli, MD, PhD, chief medical officer at OKYO Pharma, commented on the reported results in a press release from the company, saying, “We are pleased to see these patient-reported quality-of-life benefits emerging alongside the primary pain reduction signals from urcosimod. Like pain, QoL is a clinically meaningful endpoint, and this exploratory analysis reinforces the holistic therapeutic profile of urcosimod and strengthens our confidence as we advance toward larger confirmatory trials to fully characterize its potential in addressing the profound burden of NCP.”

The company announced it plans to present the new QoL data at the Association for Research in Vision and Ophthalmology (ARVO) 2026 Annual Meeting being held in Denver, Colorado, from May 3 to 7.

A multicenter phase 2b/3 multiple-dose, randomized, placebo-controlled study of urcosimod in NCP is also planned. OKYO recently completed a Type C meeting with the FDA in which the organization’s feedback backed OKYO’s phase 2b/3 plan.³

References:

1. OKYO Pharma Reports New Phase 2 Data Demonstrating Meaningful Improvements in Patient-Reported Quality of Life Outcomes with Urcosimod in Neuropathic Corneal Pain. Published March 18, 2026. Accessed March 20, 2026. https://okyopharma.com/okyo-pharma-reports-new-phase-2-data-demonstrating-meaningful-improvements-in-patient-reported-quality-of-life-outcomes-with-urcosimod-in-neuropathic-corneal-pain/

2. Harp MD. OKYO Pharma announces positive results from phase 2 trial of urcosimod for neuropathic corneal pain. Published July 18, 2025. Accessed March 20, 2026. https://www.ophthalmologytimes.com/view/okyo-pharma-announces-positive-results-from-phase-2-trial-of-urcosimod-for-neuropathic-corneal-pain

3. Harp MD. FDA Type C meeting supports phase 2b/3 pathway for urcosimod in neuropathic corneal pain. Published January 29, 2026. Accessed March 20, 2026. https://www.ophthalmologytimes.com/view/fda-type-c-meeting-supports-phase-2b-3-pathway-for-urcosimod-in-neuropathic-corneal-pain