To successfully conduct U.S. clinical trials for RCI001, we have completed a business agreement with Ora, a clinical research organization specializing in eye diseases, and are entering full-scale clinical operations.
With the production of clinical trial raw materials now complete, we are making preparations in close collaboration with Ora to successfully complete the U.S. Phase 2 clinical trial in 2022.
Ora, Inc., a U.S.-based CRO and SMO specializing in ophthalmic diseases, will conduct the clinical trial using its proprietary CAE™ (Controlled Adverse Environment) model — a more efficient and rapid approach based on extensive experience conducting dry eye disease clinical trials.
To successfully complete the U.S. clinical trial, we have recruited Clinical Team Leader Yuseung Ha, who has years of clinical research experience at IQVIA, and restructured the clinical team as an independent department to build a more agile clinical response environment.