R-Tech Ueno completes RK-023 phase I study on hypotrichosis of the eyelashes

Apr 24 2012

R-Tech Ueno (JASDAQ:4573) is pleased to announce the completion of a phase I clinical study of RK-023, a new compound that is being developed for the treatment of hypotrichosis of the eyelashes.

R-Tech Ueno has been developing this new compound (development code: RK-023), a novel physiologically active fatty acid derivative, for the treatment of dermatological diseases, and has completed a phase I clinical study of this compound as part of its development effort for the treatment of hypotrichosis of the eyelashes. This was a placebo -controlled, double-blind study conducted under the principles of Good Clinical Practice (GCP) to evaluate the safety, tolerability, and pharmacokinetics of RK-023 in eight healthy adult males and females each (16 subjects in total) by applying the study drug to the eyelid margin (at the base of the eyelashes) of the subjects for 5 consecutive days. Since the drug solution may unexpectedly enter the eyes when the study drug is applied, we also conducted another phase I clinical study to evaluate the safety and pharmacokinetics of RK-023 after a single instillation into the eyes of three healthy adult males. No adverse drug reactions were observed in either of the studies, and no ophthalmological findings (such as lowering ocular pressure and ocular hyperaemia) were observed. The results of pharmacokinetic evaluation also showed that there were hardly any safety concerns regarding RK-023.

Yukihiko Mashima, MD, PhD, President of R-Tech Ueno, commented, "R-Tech Ueno has been developing RK-023 as an anti-aging or lifestyle drug, one of the areas of the focus of our research and development. We are pleased that we have completed the phase I clinical study of RK-023 for the treatment of hypotrichosis of the eyelashes. The market for eyelash-related products, including cosmetics such as mascara, is estimated at approximately 37 billion yen in Japan. In the US, only one prescription drug for the treatment of hypotrichosis of the eyelashes has been approved for marketing by the FDA, and the distributor of the drug has announced an annual sales target of 500 million dollars. We will promote global clinical studies and seek early approval of RK-023 without eye irritation to contribute to the improvement of the quality of life (QOL) of patients with hypotrichosis of the eyelashes."