Clearside Biomedical Completes Final Participant Visit in ODYSSEY Phase 2b Trial
CLS-AX is a powerful tyrosine kinase inhibitor that is delivered suprachoroidally using Clearside’s proprietary SCS Microinjector.
The conclusion of final participant visits represents a major milestone for Clearside Biomedical, Inc. (NASDAQ: CLSD), a biopharmaceutical company committed to transforming therapy delivery to the back of the eye through the suprachoroidal space (SCS). The company has announced the completion of participant visits in the ODYSSEY Phase 2b clinical trial, which focuses on CLS-AX (axitinib injectable suspension) for the treatment of neovascular age-related macular degeneration (wet AMD). Following this important step, Clearside is now in the process of cleaning and verifying the trial's database, which will soon be locked for analysis. We can expect the topline results from this study to be released in the near future.
The Significance of the ODYSSEY Phase 2b Clinical Trial
The ODYSSEY trial is designed as a randomized, double-masked, parallel-group, active-controlled, multi-center study that spans 36 weeks and includes participants diagnosed with wet AMD. The trial aims to treat 60 participants over its duration. These participants are randomly assigned to receive either CLS-AX or aflibercept, in a 2:1 ratio. Specifically, 40 participants will receive CLS-AX, while 20 will be treated with aflibercept. The success of the treatment will be evaluated using various metrics, including changes in best-corrected visual acuity, improvements in visual function, and the overall treatment burden.
Key Outcome Measures
The primary outcome measure will assess the mean change from baseline in best-corrected visual acuity following the initial 36-week treatment period. Secondary measures will look at additional factors such as improvements in visual function and ocular anatomy, the necessity for supplemental treatment, and the frequency of injections during the trial. This comprehensive approach is designed to gather essential insights that will guide the planning and execution of future Phase 3 programs.
About CLS-AX (axitinib injectable suspension)
CLS-AX is a proprietary injectable suspension specifically designed for effective administration through the suprachoroidal route. Axitinib, a potent tyrosine kinase inhibitor (TKI), is currently used in oral tablet form to treat advanced renal cell carcinoma. This unique formulation aims to achieve extensive VEGF blockade while focusing on VEGF receptors, potentially leading to improved therapeutic results compared to existing treatments. The suprachoroidal injection method, utilizing Clearside's patented delivery system, minimizes the drug's exposure to the front of the eye while directly targeting the affected tissue layers, which may enhance treatment efficacy.
Understanding Age-Related Macular Degeneration (AMD)
Age-related macular degeneration is a leading cause of central vision loss and legal blindness, particularly among individuals over the age of 55. Wet AMD occurs due to the growth of abnormal blood vessels that leak fluid or blood into the macula, resulting in significant vision loss. In the United States, approximately 11 million people are affected by some form of AMD, with around 10% diagnosed with wet AMD. Treatments for this condition often require frequent interventions, which can be burdensome for patients and may affect their adherence to treatment, ultimately impacting outcomes.
The Economic Impact of AMD
The economic consequences of advanced AMD are substantial, with estimates in the U.S. indicating a staggering financial burden of nearly $49 billion, primarily due to productivity losses linked to visual impairment. Therefore, the development of effective, long-lasting treatments like CLS-AX presents a significant opportunity to enhance both patient health and economic outcomes.
About Clearside Biomedical, Inc.
Clearside Biomedical, Inc. is dedicated to innovating therapy delivery to address sight-threatening diseases through its suprachoroidal injection platform. The SCS Microinjector allows for repeatable, in-office procedures for targeted therapy administration. Currently, Clearside is focused on advancing CLS-AX through clinical trials, showcasing its potential to revolutionize treatment strategies for wet AMD and other retinal diseases. The company’s approved product, XIPERE (triamcinolone acetonide injectable suspension), is already making significant advancements in the market.
Frequently Asked Questions
What is the purpose of the ODYSSEY Phase 2b trial?
The ODYSSEY trial is designed to evaluate the effectiveness and safety of CLS-AX treatment in patients diagnosed with wet AMD.
How many participants are involved in the trial?
The trial aims to enroll 60 participants to compare the outcomes of CLS-AX against aflibercept.
What are the anticipated outcomes from the trial?
The primary outcome focuses on the mean change in best-corrected visual acuity, along with various secondary measures related to visual function and treatment burden.
How does CLS-AX differ from traditional treatments?
CLS-AX employs a unique suprachoroidal delivery method that aims to enhance therapeutic efficacy while reducing ocular exposure and potential side effects.
What is Clearside Biomedical’s mission?
Clearside Biomedical is committed to innovating and improving the delivery of treatments for serious eye diseases to enhance patient outcomes.
