Clearside Biomedical Completes Final Participant Visit in ODYSSEY Trial
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Clearside Biomedical Completes Final Participant Visit in ODYSSEY Phase 2b Trial
CLS-AX is a highly potent tyrosine kinase inhibitor delivered suprachoroidally using Clearside’s proprietary SCS Microinjector.
The completion of final participant visits marks a significant milestone for Clearside Biomedical, Inc. (NASDAQ: CLSD), a biopharmaceutical company focused on revolutionizing therapy delivery to the back of the eye through the suprachoroidal space (SCS). The company announced the closure of participant visits in the ODYSSEY Phase 2b clinical trial involving CLS-AX (axitinib injectable suspension), aimed at treating neovascular age-related macular degeneration (wet AMD). Following this achievement, Clearside is actively working on cleaning and verifying the trial's database, which will be locked for analysis. The topline results from the study are anticipated to be released shortly.
Importance of the ODYSSEY Phase 2b Clinical Trial
The ODYSSEY trial is structured as a randomized, double-masked, parallel-group, active-controlled, multi-center study lasting 36 weeks, involving participants diagnosed with wet AMD. It is expected that 60 participants will be treated over the duration of the trial. These individuals are randomly assigned either to receive CLS-AX or aflibercept, with a ratio of 2:1. The trial involves 40 participants receiving CLS-AX and 20 participants treated with aflibercept. Treatment success will be measured through various metrics, including changes in best-corrected visual acuity, visual function improvements, and overall treatment burden.
Key Outcome Measures
The primary outcome measure focuses on assessing the mean change from baseline in best-corrected visual acuity after the initial 36-week treatment period. Secondary measures will evaluate additional parameters such as visual function and ocular anatomy improvements, the need for supplemental treatment, and the frequency of injections required during the trial. This comprehensive approach aims to establish crucial insights that will inform the design and execution of subsequent Phase 3 programs.
About CLS-AX (axitinib injectable suspension)
Certainly, CLS-AX is a proprietary injectable suspension designed for effective administration via the suprachoroidal route. Axitinib, a potent tyrosine kinase inhibitor (TKI), is currently utilized in the oral tablet form for treating advanced renal cell carcinoma. The unique formulation aims to achieve broad VEGF blockade while specifically targeting VEGF receptors to provide better therapeutic outcomes compared to existing therapies. The method of suprachoroidal injection via Clearside's patented delivery system limits exposure of the drug to the front of the eye while delivering it directly to the affected tissue layers, thereby potentially improving treatment efficacy.
Understanding Age-Related Macular Degeneration (AMD)
Age-related macular degeneration is recognized as a primary cause of central vision loss and legal blindness, particularly in individuals over the age of 55. Wet AMD arises from the growth of abnormal blood vessels leaking fluid or blood into the macula, leading to considerable vision loss. In the United States, it is estimated that around 11 million individuals suffer from some form of AMD, with approximately 10% diagnosed with wet AMD. Treatments for this condition typically require frequent interventions, which can become burdensome and affect patient compliance, ultimately impacting treatment outcomes.
Economic Impact of AMD
The economic repercussions of advanced AMD are staggering, with estimates in the U.S. indicating a significant financial burden of nearly $49 billion, largely attributed to loss of productivity owing to the visual impairment associated with the condition. Thus, the pursuit of effective, long-lasting treatments like CLS-AX presents a compelling opportunity for improving both patient health and economic outcomes.
About Clearside Biomedical, Inc.
Clearside Biomedical, Inc. is dedicated to innovating therapy delivery to treat sight-threatening diseases through its suprachoroidal injection platform. The SCS Microinjector enables repeatable, in-office procedures for targeted therapy administration. Currently, Clearside is dedicated to advancing CLS-AX through clinical testing, highlighting its potential to transform treatment approaches for wet AMD and other retinal diseases. The company's approved product, XIPERE (triamcinolone acetonide injectable suspension), is already making strides in the market.
Frequently Asked Questions
What is the purpose of the ODYSSEY Phase 2b trial?
The ODYSSEY trial evaluates the effectiveness and safety of CLS-AX treatment in patients with wet AMD.
How many participants are involved in the trial?
The trial aims to enroll 60 participants to assess the outcomes of CLS-AX versus aflibercept.
What are the anticipated outcomes from the trial?
The primary outcome is the mean change in best-corrected visual acuity, among other secondary measures related to visual function and treatment burden.
How does CLS-AX differ from traditional treatments?
CLS-AX utilizes a unique suprachoroidal delivery method intended to enhance therapeutic efficacy while minimizing ocular exposure and side effects.
What is Clearside Biomedical’s mission?
Clearside Biomedical strives to innovate and improve the delivery of treatments for serious eye diseases to enhance patient outcomes.
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