Clearside Biomedical's Asia-Pacific Partner, Arctic Vision, Announced Acceptance of its New Drug Application for ARCATUS® for Regulatory Review in China for the Treatment of Uveitic Macular Edema

Core Viewpoint - Clearside Biomedical's partner, Arctic Vision, has had its New Drug Application for ARCATUS® accepted for review in China, supported by positive Phase 3 clinical trial results for treating uveitic macular edema [1][2][3] Company Overview - Clearside Biomedical is a biopharmaceutical company focused on innovative delivery of therapies to the back of the eye through the suprachoroidal space (SCS®) [1][8] - The company has developed a proprietary SCS Microinjector® that allows for targeted delivery of medications, potentially improving efficacy and reducing toxicity [4][8] Product Information - ARCATUS® (known as XIPERE® in the U.S.) is the first approved suprachoroidal therapy for uveitic macular edema, already approved in the U.S., Australia, and Singapore [2][5] - XIPERE® is a triamcinolone acetonide injectable suspension designed for suprachoroidal use, currently available in the U.S. through Bausch + Lomb [5][8] Market Potential - The Chinese uveitis market is significant, with several million patients affected, indicating a large potential customer base for ARCATUS® [3] - The global uveitis treatment market is projected to grow from approximately $2.3 billion in 2023 to$4.5 billion by 2032, highlighting the increasing demand for effective treatments [6][7] Collaboration and Development - Arctic Vision holds exclusive rights for the commercialization and development of XIPERE® in Greater China and other regions, and is collaborating with Santen Pharmaceutical for further development [3][5] - The company is also exploring the use of ARVN001 for other ocular retinal diseases, including diabetic macular edema [3]