OKYO Pharma Ltd (NASDAQ:OKYO), the clinical-stage drug developer, has reported encouraging safety data for its ongoing phase II clinical trial of OK-101, a drug candidate aimed at treating dry eye disease (DED).
The trial, which involves 240 patients, is designed to assess the safety, efficacy, and tolerability of OK-101.
According to the company, over 95% of the patients have completed four weeks of the planned 12-week dosing schedule, with a low dropout rate of 5.4%, unrelated to side effects.
"A key need for any drug’s approval is not only its efficacy in treating the disease but its tolerability, particularly for chronic conditions where drug dosing is anticipated to last for years," said OKYO chief executive Gary Jacob.
"In that instance, the side effect profile becomes a major concern, and although it is early in our evaluation of OK-101 in the current phase II trial, we are encouraged by what we are seeing with the administration of OK-101 to patients with DED.
"Furthermore, we are very pleased with the low level of dropouts we are seeing in this ongoing trial as well as the high 72% retention rate at 8 weeks."
All the patients are now enrolled on the double-blind placebo-controlled trial, with the top-line data read-out expected in December.