OKYO Pharma Ltd (LSE:OKYO, NASDAQ:OKYO), the ophthalmology-focused bio-pharma company, has announced that its GMP-packaged drug has cleared customs in the United States.
OK-101 will be used in the upcoming phase II clinical trial, the first-in-human trial for the treatment of dry eye disease (DED).
The company said it is now working on generating randomisation codes for its double-blinded placebo-controlled trial and obtaining authorisation for the clinical sites planned for the study.
After these activities are completed, the drug will be shipped to the trial centres.
OKYO said it anticipates that the first patient will be enrolled in the trial this quarter and aims to release top-line data from the evaluation in the fourth quarter of the year.
In a statement, the company's chief executive Gary Jacob said: "Initiation of the first-in-human phase II trial for OK-101 to treat DED has been a central and critical goal for the company for the past 18 months.
“We are excited to be very close now to moving this drug into clinical trials and believe that OK-101 can provide a new way to treat DED patients who are presently not well-served by currently approved drugs."