Clearside Biomedical has announced the completion of the final participant visit in its ODYSSEY Phase 2b clinical trial, evaluating CLS-AX (axitinib injectable suspension) for the treatment of neovascular age-related macular degeneration (wet AMD). The company anticipates releasing topline data from the trial in early October 2024, marking a significant milestone in the development of this novel therapy. The ODYSSEY trial is designed to assess the efficacy and safety of CLS-AX, delivered via suprachoroidal injection, in comparison to the standard intravitreal injection of aflibercept.
The ODYSSEY trial is a randomized, double-masked, multicenter study that enrolled 60 participants diagnosed with wet AMD. Participants were randomly assigned to receive either CLS-AX 1 mg via suprachoroidal injection or aflibercept 2 mg via intravitreal injection. The trial spanned 36 weeks, during which researchers evaluated the mean change from baseline in best-corrected visual acuity (BCVA), changes in visual function and ocular anatomy, the need for supplemental treatment, and overall treatment burden.
Potential Benefits of CLS-AX
George Lasezkay, PharmD, JD, President and CEO of Clearside Biomedical, expressed optimism about the potential of CLS-AX. "We believe there is a compelling market opportunity for CLS-AX to provide patients and physicians with a potentially safer treatment option and reduced treatment burden using axitinib, the highly-potent tyrosine kinase inhibitor (TKI), combined with delivery into the suprachoroidal space using our patented SCS Microinjector®." The suprachoroidal space (SCS) injection route aims to target the back of the eye while minimizing exposure to other parts of the eye, potentially reducing side effects.
Current Treatment Landscape and Unmet Needs
Wet AMD is a leading cause of vision loss in individuals over the age of 60. Current treatments, primarily anti-VEGF (vascular endothelial growth factor) injections like aflibercept, have significantly improved outcomes, but they require frequent intravitreal injections, which can be burdensome for patients and carry risks of complications. CLS-AX, by delivering axitinib, a tyrosine kinase inhibitor, via the suprachoroidal space, seeks to offer a more targeted and potentially safer approach, reducing the frequency of injections and improving patient compliance.
Trial Endpoints and Data Analysis
The primary endpoint of the ODYSSEY trial is the mean change from baseline in best-corrected visual acuity (BCVA). Secondary endpoints include changes in visual function and ocular anatomy, the need for supplemental treatment, and treatment burden. Following the completion of the final participant visit, Clearside Biomedical will clean and verify the study database, after which the database will be locked and the unblinded data will be analyzed. Topline results are expected to be reported in early October 2024, and the data will be presented at upcoming events, including the annual meeting of the American Academy of Ophthalmology (AAO) in Chicago.
