OKYO Pharma releases positive long-term stability data for urcosimod in neuropathic corneal pain

OKYO Pharma announced positive data in the long-term stability of urcosimod (formerly known as OK-101) for the treatment of neuropathic corneal pain (NCP).

According to the company, urcosimod has been shown to be stable for over 2 and a half years in single-use ampoules used for administration of the drug to patients. Urcosimod is currently in a phase 2b, randomized, placebo-controlled, double-masked, 48-patient clinical trial to treat NCP patients, which had the first patient dosed in October 2024.

Gary S Jacob, PhD, CEO of OKYO Pharma, and Raj Patil, PhD, chief scientific officer of OKYO Pharma, commented on the data in a press release from the company.

“Success for a drug in clinical development is not just about clinical data obtained from clinical trials but also requires a considerable amount of successful effort with what are called the chemistry, manufacturing, and controls (CMC) part of a successful submission package to the FDA,” said Jacob. "One of the major requirements for drug approval is that the drug is stable to degradation for a considerable period of time. This addresses the issue of shelf stability for a drug, and the fact that we have now established this for urcosimod is a critical positive step in meeting CMC requirements for a successful New Drug Application (NDA) with FDA.”

“Recently completed GMP stability assay testing of single-use ampoules containing urcosimod in ophthalmic solution, stored under refrigerated conditions, showed impressive stability (0.05% urcosimod – 94.8% and 0.1% urcosimod – 97.4%) after over two and a half years,” said Patil. “We are also conducting long-term stability testing of urcosimod at room temperature, and so far, the 3-month results at room temperature are at or above 100%.

OKYO recently filed an application for Fast Track designation with the US Food and Drug Administration (FDA) for urcosimod for the treatment of NCP. Urcosmid is a lipid-conjugated chemerin peptide agonist of the ChemR23 G-protein coupled receptor, typically found on immune cells of the eye responsible for the inflammatory response.

References:

1. OKYO Pharma announces positive data in long-term stability of urcosimod. Published March 31, 2025. Accessed March 31, 2025. https://www.globenewswire.com/news-release/2025/03/31/3052220/0/en/OKYO-Pharma-Announces-Positive-Data-in-Long-Term-Stability-of-Urcosimod.html