The company says top-line efficacy and safety data is on track for release in December of 2023.
OKYO Pharma has announced the last patient enrolled in its phase 2 clinical trial of OK-101 to treat dry eye disease (DED) has completed final protocol visit.
The phase 2 trial of OK-101 is a multi-center, randomized, double-masked, and placebo-controlled study evaluating the efficacy and safety of OK-101 ophthalmic solution compared to placebo in subjects with DED.1
“With the final patient visit now completed in the phase 2 DED trial, we remain on track with the release of top-line results in December of this year,” said Gary S Jacob, PhD, CEO of OKYO Pharma in a press release from the company. “OK-101 has been shown in pre-clinical animal studies to display dual-action anti-inflammatory and neuropathic corneal pain-reducing activities and we are eagerly awaiting the results of this first clinical trial of OK-101 in patients to assess the drug’s potential to treat DED.”
According to a press release from OKYO Pharma,1 data analysis plans for the trial have been finalized and submitted to the FDA for feedback, in anticipation of database lock, subsequent data analysis, and reporting of top-line findings on OK-101. According to the company, top-line efficacy and safety data is on track for release in December of 2023.
For the trial, the approximately 240 subjects with DED were randomly divided into 3 cohorts of 80 patients. Participants were selected based on specific inclusion and exclusion criteria. The 3 cohorts included 1 cohort treated with placebo, a second cohort treated with 0.05% OK-101, and the third cohort receiving 0.1% OK-101.1 The first patient in the trial was dosed back in June.
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.” Furthermore, according to the company, OK-101 has been shown to produce anti-inflammatory and pain-reducing activities in mouse models of dry eye disease and corneal neuropathic pain (NCP), respectively.
OKYO Pharma recently filed an Investigational New Drug (IND) application with the FDA to develop OK-101 to treat Neuropathic Corneal Pain (NCP). For NCP, OKYO said it plans to commence enrollment in the study in the first quarter of 2024 following IND allowance by the FDA.