Clearside Biomedical announced positive results from a meeting with the FDA regarding its Phase 3 clinical trial plans for CLS-AX, a treatment for wet age-related macular degeneration (wet AMD). The FDA agreed with Clearside’s proposed Phase 3 program design, signaling a crucial step toward potential approval of this new therapy. CLS-AX, administered via Clearside’s patented suprachoroidal injection technology, offers a potential advantage over existing treatments with its flexible dosing schedule and longer duration of effect.
This development is particularly important for wet AMD patients who require individualized treatment plans. Current therapies often necessitate frequent injections, placing a burden on patients and healthcare providers. A longer-acting treatment like CLS-AX could significantly improve patient convenience and compliance, potentially leading to better outcomes. Furthermore, the potential for reduced injection frequency could streamline treatment protocols, optimizing the use of healthcare resources.
The planned Phase 3 program consists of two concurrent, non-inferiority trials comparing CLS-AX to the current standard of care, aflibercept. The primary endpoint is the average change in best corrected visual acuity (BCVA) at week 52. The trials are designed to support a flexible dosing schedule of CLS-AX every 3 to 6 months, based on individual patient needs. The inclusion of treatment-naïve participants allows for a broader representation of the wet AMD population and potentially faster recruitment.
The positive FDA feedback and well-defined Phase 3 program represent significant progress for Clearside Biomedical. Successful completion of these trials could position CLS-AX as a valuable new treatment option for wet AMD, addressing a significant unmet need in this large and growing market. This positive outcome may also validate Clearside’s suprachoroidal injection platform, paving the way for further development of its pipeline of therapies for other retinal diseases.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
