Core Insights - Clearside Biomedical is advancing its lead clinical program, CLS-AX, for the treatment of neovascular age-related macular degeneration (wet AMD) through its innovative 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 suprachoroidal injection 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, indicating its potential for prolonged duration and targeted delivery to affected tissues [8][10] - The SCS Microinjector® allows for precise drug delivery to the back of the eye, potentially reducing the risk of complications associated with traditional intravitreal injections [9][10] Group 2: Market and Regulatory Landscape - The wet AMD market is significant, valued at over $12 billion, and there is a growing demand for innovative treatment options [5] - Clearside's regulatory strategy for CLS-AX is informed by recent interactions with the FDA, guiding the design of its Phase 3 clinical trial plans [5][6] - The company aims to enhance treatment options for wet AMD, addressing the high treatment burden associated with current anti-VEGF therapies [3][4]
Clearside Biomedical's Lead Clinical Program CLS-AX in Wet AMD and Suprachoroidal Delivery Platform Highlighted at the 2025 Wet AMD & Diabetic Eye Disease Summit