OKYO Pharma Ltd (LSE:OKYO, NASDAQ:OKYO) said it has filed an investigational new drug (IND) application with the US authorities for OK-101, its putative treatment for dry eye disease.
It plans to carry out a phase II trial after being allowed to skip the initial safety phase by the US Food and Drug Administration (FDA).
Progress was aided by what is called a meeting pre-IND with the American drug regulator that provided guidance on the primary and secondary efficacy ‘endpoints’.
“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 filing with the FDA,” OKYO chief executive Gary Jacob said.
The study is expected to get underway in the first quarter of next year.
Dry eye disease is a poorly treated condition exacerbated by the use of computers and smartphones. OKYO estimates it is a potential "multi-billion dollar" market.