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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 Macula...

Clearside Biomedical, Inc. (CLSD) 
Last clearside biomedical, inc. earnings: 3/11 04:05 pm Check Earnings Report
US:NASDAQ Investor Relations: ir.clearsidebio.com/investor-overview
Company Research Source: GlobeNewswire
ALPHARETTA, Ga., Feb. 20, 2025 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD) (“Clearside” or the “Company”), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), reported that Arctic Vision’s New Drug Application (NDA) for ARCATUS® for the treatment of uveitic macular edema (UME) 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 XIPERE® 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 Food and Drug Administration in the United States, Therapeutic Goods Administration in Australia, and the Health Sciences Authority in Singapore. Georg Show less Read more
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