OKYO Pharma completes enrollment of phase 2 trial for dry eye disease treatment
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OKYO Pharma has completed patient enrollment for the randomized portion of its phase 2 clinical trial of OK-101, a topical treatment for dry eye disease, the company announced in a press release.
“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,” Gary S. Jacob, PhD, CEO of OKYO Pharma, said in the release. “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.”
According to the release, OK-101 is a lipid conjugated chemerin peptide agonist of the ChemR23 G-protein coupled receptor and was created using membrane-anchored peptide technology for long-acting effect. The product produced anti-inflammatory and pain-relieving results in dry eye disease and corneal neuropathic pain, respectively, in preclinical studies.
The multicenter, randomized trial will divide participants into three cohorts of 80 patients, who will be treated with placebo, 0.05% OK-101 or 0.1% OK-101 twice-daily in both eyes for 12 weeks. The primary study endpoints include both a sign and symptom of dry eye disease.
“The phase 2 clinical trial is a crucial step in the development of OK-101, evaluating its safety, efficacy and tolerability in the population of 240 DED patients comprising the study,” Raj Patil, PhD, OKYO’s chief scientific officer, said in the release. “We remain committed to establishing the potential of this drug to treat the many millions of people currently suffering from DED.”
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