Okyo Pharma, Ltd., announced that urcosimod (formerly known as OK-101), its treatment for neuropathic corneal pain (NCP), 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. The therapy is presently in a phase 2b, randomized, placebo-controlled, double-masked, 48-patient clinical trial in subjects with NCP. Currently, there is no FDA approved therapy for NCP.

“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 2 and a half years,”Raj Patil, PhD, chief scientific officer at Okyo Pharma, said in a company press release,

Urcosimod 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, as well as on neurons and glial cells in the dorsal root ganglion, the company stated in the press release. It was developed using a membrane-anchored-peptide technology to produce a novel long-acting drug candidate for treating dry eye disease (DED). Okyo Pharma said that urcosimod has been shown to produce anti-inflammatory and pain-reducing activities in mouse models of DED and corneal neuropathic pain, respectively, and is designed to combat washout through the inclusion of the lipid anchor built into the drug molecule to potentially enhance the residence time of urcosimod within the ocular environment. The therapy showed clear statistical significance in multiple endpoints in a recently completed phase 2, multi-center, double-masked, placebo-controlled trial to treat DED, the company said.

Okyo Pharma is also “conducting long-term stability testing of urcosimod at room temperature, Dr. Patil said, with 3-month results at room temperature at or above 100% so far. “It’s important to highlight that urcosimod is administered to patients as eye drops, and we have been pleased not only with the drop comfort score observed with this drug but also with the efficacy results from an earlier trial of urcosimod to treat DED,” he said.

Commercial marketing of ophthalmic drugs for ocular conditions, which typically utilizes small plastic bottles, has seen an increasing utilization of single-use ampoules by patients for ocular conditions such as DED, for ease of use, and for minimizing concerns regarding potential loss of sterility with use of plastic bottles for daily administration of drug over extended periods.