OKYO Pharma Ltd said it plans to file an IND for its dry eye disease (DED) treatment OK-101 in the third quarter of 2022 based on the results so far from animal models and tolerance studies.
OK-101 has been designed to combat washout from the eye through the inclusion of a lipid ‘anchor’ within the candidate drug molecule to “enhance the residence” time of OK-101 on the ocular surface.
A CRO (contract research organisation), Ora Inc, has been appointed to help with the IND application in areas such as the documentation for meeting with US regulator the FDA and support in other areas such as quality oversight in the development of a topical formulation.
IND approval allows a drug to progress to in-human clinical trials.
Clinical trials should be able to start with OK-101 as early as one month after submission of the IND, OKYO added.
The main market-listed company said it also intends to expand the range on eye conditions that it can potentially treat.
“During the next year, we will be continuing to conduct preclinical studies and additional animal studies to further evaluate the OK-201 preclinical candidate to treat corneal neuropathic pain,” Okyo said alongside its results for the year to end-March 2021.
Losses for the year were GBP2.99mln (GBP1.21mln), with cash at the year-end of GBP4.99mln.
OKYO added that based on its current projected spending it has the cash to fund its work until the end of 2022.