Client NewsOKYO Pharma Limited: Successful Pre-IND Meeting with the FDA on OK-101
OK-101 First-in-Human Trial planned as Phase 2 Trial incorporating Primary Efficacy Endpoints covering Signs and Symptoms of Dry Eye Disease
London and Boston, MA, February 15, 2022 – OKYO Pharma Limited (LSE: OKYO; OTCQB: EMMLF), a biotechnology company focused on the discovery and development of novel molecules to treat inflammatory dry eye diseases and ocular pain, today announced the successful completion of a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) regarding the development plans for OK-101 to treat dry eye disease (DED).
Both nonclinical and clinical development milestones were covered in the Pre-IND meeting facilitated by Ora Inc., with the FDA providing guidance on the proposed phase 2 trial in DED patients. FDA concurred with OKYO’s decision to designate co-primary efficacy endpoints covering both a sign and a symptom of dry disease in the clinical protocol of the trial.
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