Clearside Biomedical has announced positive results from its Phase II clinical trial evaluating CLS-AX (axitinib injectable suspension) for the treatment of wet age-related macular degeneration (AMD), paving the way for a Phase III program. The trial's findings suggest that CLS-AX, when administered via suprachoroidal injection (SCS) in combination with an anti-VEGF agent, could offer a promising new approach to managing wet AMD.
The study evaluated the safety and efficacy of CLS-AX, a tyrosine kinase inhibitor, delivered directly into the SCS, a space located between the sclera and the choroid. This targeted delivery method aims to maximize drug concentration at the back of the eye while minimizing systemic exposure. The trial enrolled patients with treatment-naïve wet AMD and compared the outcomes of those receiving CLS-AX in conjunction with an anti-VEGF agent to those receiving anti-VEGF monotherapy.
Key Findings
Preliminary data suggest that the combination therapy may allow for a reduced treatment burden, potentially decreasing the frequency of anti-VEGF injections needed to maintain vision. Detailed results from the Phase II trial are expected to be presented at an upcoming medical conference. These results will provide a more comprehensive understanding of the efficacy and safety profile of CLS-AX in treating wet AMD.
Implications for Wet AMD Treatment
Wet AMD is a leading cause of vision loss in individuals over the age of 60. Current standard of care involves frequent intravitreal injections of anti-VEGF agents to inhibit the growth of abnormal blood vessels in the macula. While effective, the need for repeated injections poses a significant burden on patients and healthcare providers. CLS-AX, with its unique delivery method and potential for reduced injection frequency, represents a significant advancement in the treatment landscape.
Clearside's SCS Injection Platform
Clearside Biomedical's proprietary SCS injection platform is designed to deliver therapeutic agents directly to the back of the eye, targeting the affected tissues while minimizing systemic side effects. This innovative approach has the potential to transform the treatment of various retinal diseases, including wet AMD, diabetic macular edema, and retinal vein occlusion.
