OKYO Pharma Ltd (NASDAQ:OKYO) announced that it has completed full enrollment of patients in the randomized portion of the Phase 2 multi-center, double-masked, placebo-controlled clinical trial of topical ocular OK-101 to treat dry eye disease (DED).
The clinical stage biopharmaceutical company said the Phase 2 trial is designed as a potential registration trial, with pre-specified primary efficacy endpoints covering both a sign and symptom of dry eye disease.
"This trial began in May of this year, and we have been pleased with the rapid pace of enrollment in the trial which has been managed by our clinical development partner Ora Inc, a world leader in dry eye clinical research," OKYO Pharma CEO Gary Jacob said in a statement.
"We now have 240 patients enrolled in the trial and are anticipating the last-patient last-visit to occur in the last week of November 2023, with the planned release of top-line data occurring in December 2023," he added.
DED is a common condition that occurs when one’s tears are unable to adequately lubricate the eyes, which typically leads to inflammation and damage to the ocular surface and pain and affects about 49 million people in the US alone, according to the company.
OKYO Pharma is focusing on the discovery and development of novel molecules to treat inflammatory dry eye diseases and ocular pain.
Its therapeutic candidate OK-101 is a lipid-conjugated chemerin peptide agonist of the ChemR23 G-protein coupled receptor which is typically found on immune cells of the eye responsible for the inflammatory response.
Contact Sean at sean@proactiveinvestors.com