The US Food and Drug Administration (FDA) has granted clearance for OKYO Pharma's investigational new drug (IND) application enabling the commencement of a Phase II clinical trial of OK-101 aimed at treating neuropathic corneal pain (NCP).

A lipid-conjugated chemerin peptide agonist that acts on the chemerin receptor 23 (ChemR23) G-protein coupled receptor, OK-101 is developed leveraging a membrane-anchored-peptide technology.

The single-centre, double-masked, randomised, 12-week, placebo-controlled, open-label trial will evaluate OK-101 versus placebo in patients with NCP.

This trial of the long-acting drug candidate will involve a total of 54 participants.

The primary endpoint will be the Visual Analogue Scale (VAS) pain relief scores.

The design of the trial is structured to provide a statistically valid demonstration of OK-101's true drug effect on NCP symptoms.

OKYO plans to initiate the trial in the second quarter of this year.

The study will be led by Tufts Medical Center Research and Academic Programs professor and vice-chair Dr Pedram Hamrah, as the principal investigator.

OK-101 has previously demonstrated clear statistical significance in multiple endpoints during a concluded Phase II trial for dry eye disease (DED).

It also showed anti-inflammatory and pain-reducing activities in mouse models of DED and NCP.

OKYO Pharma CEO Dr Gary Jacob said: “OK-101 recently demonstrated favourable tolerability in a Phase II trial of dry eye patients along with statistically significant improvements in dry eye symptoms such as stinging/burning and blurred vision, which are also hallmarks of NCP.

“We are looking forward to advancing OK-101 to potentially treat NCP, a chronically painful ocular disease with no FDA-approved therapy and a major unmet medical need for patients suffering from this condition.”