28th Feb 2023 16:01
(Alliance News) - Okyo Pharma Ltd on Tuesday said its good manufacturing practice-packaged OK-101 drug has cleared customs in the US.
The London-based ophthalmology-focused bio-pharmaceutical company said the drug treats dry eye disease to address the "significant unmet need in this multi-billion-dollar market".
It said the customs clearing comes as the drug is to be used in the upcoming phase 2, first-in-human, clinical trial in patients with dry eye disease, which was recently shipped from Europe.
Okyo said it is now in the process of having randomization codes generated for its double blinded placebo-controlled trial, along with other activities needed for initiating the trial, including authorisation of those clinical sites planned for the phase 2 clinical trial.
Once these activities are completed, it plans to ship to the sites involved in the trial.
Okyo said it expects the first-patient-first visit in the first quarter of 2023 and it is looking to release top-line data from this trial in the fourth quarter.
"Initiation of the first-in-human phase 2 trial for OK-101 to treat dry eye disease has been a central and critical goal for the company for the past 18 months," said Chief Executive Officer Gary Jacob.
"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 dry eye disease patients who are presently not well-served by currently approved drugs."
Shares in Okyo were down 2.0% to 3.43 pence each in London on Tuesday afternoon.
By Greg Rosenvinge, Alliance News reporter
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