OKYO Pharma Files US IND Application For Dry Eye Disease Candidate - OKYO Pharma (NASDAQ:OKYO)

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  • 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.
  • Photo Via Company

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Image and article originally from www.benzinga.com. Read the original article here.