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Clearside Biomedical's Partner Arctic Vision Reports Positive Topline Results from Phase 3 Clinical Trial of ARCATUS® for Suprachoroidal Use in Uveitic Macular Edema Patients in China
Clearside BiomedicalClearside Biomedical(US:CLSD) Newsfilter·2024-07-29 20:05

Company Overview - Clearside Biomedical, Inc. is a biopharmaceutical company focused on revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS) [4] - The company has developed a patented SCS Microinjector that allows for a non-surgical procedure to deliver therapies to the macula, retina, or choroid [4] Product Development - The lead program, CLS-AX (axitinib injectable suspension), is currently in Phase 2b clinical testing for the treatment of neovascular age-related macular degeneration (wet AMD) [2] - Clearside's first product, XIPERE® (triamcinolone acetonide injectable suspension), is approved for suprachoroidal use and is available in the U.S. through a commercial partner [2][8] Strategic Partnerships - Clearside partners with companies to utilize its SCS injection platform alongside other ophthalmic therapeutic innovations [2] - Arctic Vision holds exclusive rights for the commercialization and development of XIPERE in several regions, including Greater China and South Korea [6][8] Clinical Trial Results - Arctic Vision reported positive topline results from its Phase 3 clinical trial of ARCATUS® (ARVN001) for Uveitic Macular Edema (UME) in China, meeting both primary and secondary endpoints [11][12] - In the trial, 38.5% of ARVN001-treated patients gained 15 or more letters in vision compared to 9.4% in the sham group, with a significant reduction in central subfield thickness (CST) [12] Market Potential - Uveitis affects approximately 350,000 patients in the U.S. and over one million globally, with a significant portion developing uveitic macular edema [9] - The uveitis market is projected to grow to nearly $550 million in the U.S. and over $1 billion globally by 2024 [9]