OKYO Pharma Ltd (LSE:OKYO, NASDAQ:OKYO) said its dry eye disease treatment has received clearance for its investigational new drug (IND) application from the US Food and Drug Administration (FDA) to initiate a phase 2 study.
First-in-human clinical studies of OK-101 are expected to open for enrolment in the first quarter of 2023, the biopharmaceutical company said.
"We are very pleased to receive clearance from the FDA to initiate our OK-101 Phase 2 study," said Gary S Jacob, chief executive officer of OKYO Pharma in a statement.
"We believe this first-in-human study will help demonstrate that OK-101 may provide a new way to treat DED patients who are not well-served by currently approved drugs.
“The clearance of our IND for OK-101 has been a key priority for the company this past year, and we are excited to be moving this drug into the clinic in the first quarter of 2023," he added.
The company noted that OK-101 has been proven to produce anti-inflammatory and neuropathic pain-reducing activities in the mouse models of dry eye disease and corneal neuropathic pain.
OK-101 is also designed to combat washout through the inclusion of a lipid anchor, meaning the treatment can stay in the infected area for longer.