OKYO Pharma Ltd (LSE:OKYO, NASDAQ:OKYO) said the first patient has been screened for the phase II trial of OK-101, a treatment for dry eye disease (DED).
It aims to evaluate the drug's efficacy and safety in DED patients. Top-line data is expected before the end of 2023.
Gary Jacob, CEO of OKYO, said the study marked a significant step for the company.
If successful, this phase II assessment could also serve as one of the two required phase III studies necessary for US Food & Drug Administration approval.
Dry eye disease affects about 49 million people in the US and has been challenging to diagnose and treat.
OKYO's trial will enrol around 240 people, divided into three groups or cohorts, with each receiving either a placebo, a low dose of OK-101, or a higher dose of the drug. Treatment will last for 12 weeks.