OKYO Pharma Limited OKYO filed an Investigational New Drug (IND) application with the FDA for the development of OK-101 to treat dry eye disease (DED).
Both nonclinical and clinical development plans on OK-101 were reviewed with the FDA in an earlier Pre-IND meeting, with the FDA agreeing to a first-in-human Phase 2 trial in DED patients.
FDA also concurred with OKYO’s plans for designating primary and secondary efficacy endpoints covering both a sign and a symptom of DED in the trial’s clinical protocol.
“The filing of this IND with the 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,” said Gary S. Jacob, Ph.D., CEO of OKYO Pharma.
OK-101 is a lipid-conjugated chemerin peptide agonist of the ChemR23 G-protein coupled receptor, typically found on immune cells of the eye responsible for the inflammatory response.
OK-101 has been shown to produce anti-inflammatory and neuropathic pain-reducing activities in mouse models of DED and corneal neuropathic pain, respectively.
Price Action: OKYO shares closed lower by 3.18% at $2.13 on Friday.
