Clearside Biomedical’s partner in China granted acceptance of arcatus NDA

Clearside Biomedical (CLSD) reported that Arctic Vision’s New Drug Application or NDA for arcatus for the treatment of uveitic macular edema has been formally accepted for review by the Center for Drug Evaluation of China National Medical Products Administration. The NDA submission is supported by positive topline results from Arctic Vision’s Phase 3 UME clinical trial in China. Arcatus, known as Xipre in the U.S., utilizes Clearside’s proprietary SCS Microinjector and is the first and currently only approved suprachoroidal therapy to treat UME. It has already been approved by the FDA in the U.S., Therapeutic Goods Administration in Australia, and the Health Sciences Authority in Singapore. Arctic Vision is a China-based ophthalmic biotech company that has the exclusive license for the commercialization and development of Xipre for suprachoroidal use, which they refer to as Arcatus in Greater China, South Korea, Australia, New Zealand, India and the ASEAN Countries. Arctic Vision has a commercial collaboration agreement with Santen Pharmaceutical to commercialize ARVN001 for the treatment of UME and certain other ophthalmic indications under development in China, excluding Taiwan, Hong Kong and Macau.