OKYO Pharma Ltd said the US regulator has given it the green light to take its dry eye disease treatment directly into a phase II clinical trial.
The Food & Drug Administration’s decision to fast-track the OK-101 in this manner will accelerate the approval process, the company said.
The decision followed the successful conclusion of a pre-IND (investigational new drug) meeting with the FDA.
At that gathering it was also decided there would be two primary goals or ‘endpoints’ for the phase II trial covering both a sign and a symptom of dry disease.
“The fact that we are designating efficacy endpoints as primary endpoints in this first-in-human trial is highly significant,” said OKYO chief executive Gary Jacobs.
“Should our upcoming trial meet its prespecified primary endpoints, this would be an important step in reducing the timeline to a new drug application filing with the FDA."
The company previously said it expects the study will involve 100 to 200 people with dry eye disease.
It will be overseen by Ora Inc, the group’s ophthalmic clinical development partner, and is expected to be completed in six to eight months from first enrolment.
OK-101 is being developed as a long-acting anti-inflammatory drug candidate. The technology is based around G protein-coupled receptors typically found on immunological cells present in the eye.
They act like an inbox for messages in the form of light energy, peptides that fight bacteria and promote wound healing, lipids, sugars, and proteins.
Currently, the two leading products for dry eye disease are Xiidra, created by Novartis (NYSE: NVS), and Restasis, developed by Abbvie (NYSE:ABBV) (Abbvie (NYSE:ABBV)) (NYSE: ABBV).