OKYO Pharma Reports Positive OK-101 Phase 2 Dry Eye Trial Data

OKYO Pharma Limited has announced promising new data from their recent Phase 2 trial of OK-101 in patients with dry eye disease (DED). The trial, which involved 240 patients, identified conjunctival staining and ocular pain as key endpoints to be explored in future studies. These endpoints could serve as co-primary measures in the next trial for OK-101.

“The initial human trial of OK-101 in DED patients has provided a clear direction for future clinical development,” said Gary S. Jacob, Ph.D., CEO of OKYO Pharma. “Our analysis suggests that conjunctival staining and ocular pain are critical endpoints that can significantly benefit patients who suffer from the pain component of dry eye symptoms. Additionally, this trial demonstrated a good tolerability profile for OK-101, with an excellent comfort score for the eyedrop formulation.”

Gabriele Cerrone, Non-Executive Chairman of OKYO Pharma, added that dry eye disease affects a diverse and often dissatisfied patient population in need of more effective treatment options. “We are dedicated to advancing our innovative program focused on patients most impacted by ocular pain. We will evaluate next steps for dry eye treatment with our advisors and regulatory agencies,” he said.

The Phase 2 trial was a randomized, double-masked, placebo-controlled study that evaluated the safety and efficacy of OK-101 ophthalmic solution in subjects with DED. The data analysis included a categorical evaluation and responder-rate analyses of the entire Intent-to-Treat population.

Key findings from the trial showed that 34.2% of patients treated with OK-101 experienced at least a 12.5% reduction in conjunctival sum staining combined with a 30% reduction in ocular pain, compared to 20.3% in the placebo group, marking a 68% improvement. Similarly, 32.9% of OK-101-treated patients reported reductions in conjunctival staining and burning/stinging symptoms, compared to 20.3% in the placebo group, representing a 62% improvement. There was a smaller 19% difference in responder rates for patients reporting both conjunctival staining and blurred vision.

Dry eye disease is a common condition in which tears fail to adequately lubricate the eyes, affecting roughly 49 million people in the U.S. alone. The condition is multifactorial and can be influenced by age, sex, medical conditions, reduced tear production, and tear film dysfunction, leading to inflammation and damage to the ocular surface.

OK-101 is a lipid-conjugated chemerin peptide agonist of the ChemR23 G-protein coupled receptor. This receptor is typically found on immune cells in the eye and is responsible for the inflammatory response. OK-101 was developed using membrane-anchored-peptide technology to create a long-acting drug candidate for treating dry eye disease. The inclusion of a lipid anchor in the drug molecule is designed to enhance its residence time within the ocular environment. OK-101 has shown anti-inflammatory and pain-reducing efficacy in preclinical models and demonstrated statistical significance in multiple endpoints in the Phase 2 trial.

In addition to its work on dry eye disease, OKYO Pharma is planning a Phase 2 trial for OK-101 to treat neuropathic corneal pain (NCP), a condition with no FDA-approved therapies. OKYO Pharma Limited is a clinical-stage biopharmaceutical company focused on developing innovative ocular therapies for DED and NCP.