Okyo files investigational new drug application for dry eye disease treatment
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Okyo Pharma has submitted an investigational new drug application to the FDA for OK-101 for the treatment of dry eye disease.
OK-101, a lipid conjugated chemerin peptide agonist of the ChemR23 G-protein, is designed to prevent washout in dry eye disease by using a lipid “anchor” to enhance the residence time of OK-101 in the ocular environment, according to a press release.
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The FDA previously agreed to a first-in-human phase 2 trial of OK-101 that will incorporate primary and secondary efficacy endpoints characterizing signs and symptoms of dry eye disease.
“The filing of this IND with FDA is a key step for Okyo as we advance our plan to open a phase 2 trial in DED patients in the first quarter of 2023,” Gary S. Jacob, PhD, CEO of Okyo Pharma, said in the release. “The fact that we are designating primary and secondary efficacy endpoints in this first-in-human trial is highly significant as should our upcoming trial of OK-101 meet its prespecified primary endpoint, it could accelerate the timeline to a new drug application filing with the FDA.”
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