OKYO Pharma Ltd (NASDAQ:OKYO) announced that it will be releasing new and comprehensive data from its Phase 2 trial of its investigational therapeutic OK-101 in dry eye disease on Friday, March 22, with plans to advance the drug into Phase 3 trials later in 2024.
The company said it will host a Key Opinion Leader event to go over its Phase 2 study results, featuring prominent experts in the field of dry eye disease who will provide insights on the clinical significance of the findings and the potential implications for patient care and future research.
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.
During the Phase 2 trial, patients were divided into three arms, one of which was dosed with 0.05% OK-101, one with 0.1% OK-101 and the third with vehicle. Patients were dosed twice daily for 14 weeks, including a two-week run-in period on a placebo to exclude placebo responders from the study.
OKYO highlighted that its earlier research has shown OK-101 has statistically significant drug effects in FDA-recognised efficacy endpoints as early as the 15-day mark after dosing.
“The upcoming data release follows the successful completion of OKYO Pharma's Phase 2 trial, which focused on assessing the efficacy and safety of OK-101, our novel topical therapeutic candidate for dry eye disease,” OKYO Pharma CEO Dr Gary Jacob said.
“We plan to advance OK-101 into Phase 3 clinical trials in 2024, with the goal of developing a highly differentiated dry eye product to help patients underserved by current treatments. Our parallel development focus for OK-101 in 2024 is the evaluation of this drug candidate to treat neuropathic corneal pain for which we have already received IND clearance to begin clinical studies.”
OKYO Pharma is a clinical-stage biopharmaceutical company developing innovative therapies for the treatment of dry eye disease and neuropathic corneal pain.