Today, RudaCure has officially entered domestic clinical trials following the final approval by the Ministry of Food and Drug Safety (MFDS) of the clinical trial protocol titled "A randomized, double-blind, placebo-controlled, single and repeated instillation, Phase 1 clinical study to explore the pharmacokinetics, safety and tolerability of RCI001 ophthalmic solution 0.25% in healthy adult males."
The trial site is Seoul National University Hospital, and the study will be conducted by Professor Lee Seung-hwan.
RCI001 is an endogenous substance-based dry eye disease treatment that has demonstrated excellent preclinical results for dry eye disease through increased tear volume, suppression of intraocular inflammation, and recovery of the meibomian glands. Given the safe tolerability demonstrated across various toxicology studies, the company expects the Phase 1 clinical trial to proceed smoothly.
We have reached this milestone with the help of many people, and we would like to express our sincere gratitude to all those who have supported us.
We will continue to work hard to deliver good news to you more frequently.