Clearside Biomedical Announces Positive Topline Results from ODYSSEY Phase 2b Trial of Suprachoroidal CLS-AX in Wet AMD Achieving All Primary and Secondary Outcomes

Core Insights - Clearside Biomedical announced positive topline data from the ODYSSEY Phase 2b clinical trial of CLS-AX for treating wet AMD, achieving both primary and secondary outcomes [1][2][5] Clinical Trial Overview - The ODYSSEY trial was a randomized, double-masked, parallel-group, active-controlled, multicenter study lasting 36 weeks, involving 60 participants previously treated with standard anti-VEGF therapy [3][4] - Participants were randomized to receive either CLS-AX (1 mg) or aflibercept (2 mg) with a 2:1 ratio [3] Efficacy Results - CLS-AX maintained stable best corrected visual acuity (BCVA) and central subfield retinal thickness (CSRT) throughout the trial [5][6] - 67% of CLS-AX participants did not require additional treatment up to 6 months, with a significant reduction in treatment burden by 84% compared to prior injections [1][6] Safety Profile - CLS-AX demonstrated a positive safety profile with no ocular or treatment-related serious adverse events reported throughout the trial [1][6] - The treatment was well-tolerated, with similar discontinuation rates between CLS-AX and aflibercept groups [6] Future Development - The positive results support advancing CLS-AX into Phase 3 development, with the potential for a flexible maintenance dosing regimen between 3 to 6 months [2][5] - The company aims to provide a new treatment option with meaningful efficacy and safety benefits for patients with wet AMD [2][8] Technology and Delivery Method - CLS-AX utilizes Clearside's proprietary SCS Microinjector for suprachoroidal delivery, allowing targeted treatment to the back of the eye [8][11] - This method may offer advantages over existing therapies by achieving pan-VEGF blockade and potentially longer-lasting effects [8][11] Market Context - Wet AMD is a leading cause of vision loss, affecting approximately 11 million patients in the U.S., with significant economic impacts estimated at $49 billion [9] - Current treatments require frequent injections, leading to a high treatment burden and reduced patient compliance [9]