Okyo files for FDA clearance to start trial of dry eye disease therapy
Okyo Pharma (NASDAQ:OKYO) said it filed an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) seeking clearance to start a trial of OK-101 to treat dry eye disease (DED).
The London-based company added that the FDA agreed to a phase 2 trial in patients with DED. Okyo plans to start the study in Q1 2023.
Both nonclinical and clinical development plans on OK-101 were reviewed with the FDA in an earlier pre-IND meeting helped by Okyo's contract research organization Ora, the company noted.
The FDA also agreed with Okyo's plans for designating main and secondary efficacy goals covering both a sign and a symptom of DED in the trial's protocol, according to the company.
"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 (NDA) filing with the FDA," said Okyo's CEO Gary Jacob.
DED is a condition that occurs when the eye does not produce enough or the right type of tears to provide lubrication for the eyes.