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

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 [1][6][9] - 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 [2][3] 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 [6][7] - 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 tissues [7][8] - The company is planning a Phase 3 trial for CLS-AX following a successful End-of-Phase 2 meeting with the FDA, indicating a strong regulatory strategy [3][4] Group 2: Market Context and Regulatory Strategy - The wet AMD market is significant, valued at over $12 billion, and there is a growing demand for innovative treatment options that can reduce the treatment burden on patients [4][9] - Clearside's presentations at the 2025 Wet AMD & Diabetic Eye Disease Summit highlighted the limitations of current anti-VEGF therapies and the potential of suprachoroidal delivery to transform treatment [2][3] - The company is actively engaging with the FDA to navigate the regulatory landscape for wet AMD therapies, which will inform its clinical development plans [4][9]