OKYO Pharma Reports Positive Long-Term Stability Data for Urcosimod in Neuropathic Corneal Pain

OKYO Pharma has announced encouraging data on the long-term stability of urcosimod (formerly OK-101), its investigational therapy for neuropathic corneal pain (NCP). The findings support the drug’s potential shelf life and regulatory readiness, representing a critical step in its path toward FDA approval.

Over 2.5 Years of Stability in Ophthalmic Ampoules

According to the company, urcosimod has demonstrated stability for more than 2.5 years in single-use ophthalmic ampoules stored under refrigerated conditions. This achievement is a key component of the drug’s chemistry, manufacturing, and controls (CMC) data required for a New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA).

“Success for a drug in clinical development is not just about clinical data... It also requires successful efforts in CMC, including demonstrating long-term stability,” said Gary S. Jacob, PhD, CEO of OKYO Pharma.
“The fact that we have now established this for urcosimod is a critical positive step toward meeting FDA requirements.”

Phase 2b Trial for NCP Underway

Urcosimod is currently being evaluated in a Phase 2b randomized, placebo-controlled, double-masked clinical trial involving 48 patients with NCP. The first patient was dosed in October 2024. This trial aims to assess the efficacy of urcosimod in addressing pain symptoms associated with this rare and often debilitating ocular condition.

Strong Stability Data from GMP Testing

Dr. Raj Patil, Chief Scientific Officer at OKYO Pharma, elaborated on the findings:

“Recently completed GMP stability testing of urcosimod in ophthalmic solution showed impressive results after more than two and a half years:

       • 0.05% urcosimod retained 94.8% stability

       • 0.1% urcosimod retained 97.4% stability”

In addition to refrigerated testing, room temperature stability studies are ongoing. Early data show 100%+ stability at 3 months.

Fast Track Designation Application Filed with FDA

OKYO recently submitted a Fast Track designation application to the FDA for urcosimod in the treatment of neuropathic corneal pain.

Urcosimod is a lipid-conjugated chemerin peptide and a potent agonist of the ChemR23 G-protein coupled receptor, which is predominantly expressed on immune cells in the eye involved in inflammatory responses.