Clearside Biomedical(CLSD) Newsfilter·2025-03-20 11:05Core Insights - Clearside Biomedical is advancing its lead clinical program, CLS-AX, for the treatment of neovascular age-related macular degeneration (wet AMD) through its unique suprachoroidal delivery platform [2][10] - The company emphasizes the need for more sustainable and less frequent treatment options for wet AMD, highlighting the potential benefits of its innovative delivery method [3][4] Group 1: Clinical Program and Technology - CLS-AX is a proprietary injectable suspension of axitinib, a tyrosine kinase inhibitor (TKI), designed for suprachoroidal injection, which may offer advantages over existing therapies by achieving pan-VEGF blockade [7][8] - Recent clinical trials have shown that CLS-AX is well tolerated and has a positive safety profile, with the potential for prolonged duration and targeted delivery to affected tissue layers [8][9] - The suprachoroidal injection method could reduce the risk of complications such as endophthalmitis and cataract, which are associated with traditional intravitreal therapies [4][5] Group 2: Regulatory and Market Context - The wet AMD market is significant, valued at over $12 billion, and the company is preparing for a Phase 3 clinical trial following successful discussions with the FDA [5][10] - Clearside's regulatory strategies are informed by recent FDA guidance, which will shape the development of CLS-AX and its positioning in the market [5][6] - The company aims to transform treatment options for retinal diseases through its patented SCS Microinjector, which allows for targeted and compartmentalized drug delivery [9][10]