Pharma Focus Europe

Clearside Biomedical Commences Enrolling Numerous Participants in ODYSSEY Phase 2b Clinical Trial Assessing CLS-AX (Axitinib Injectable Suspension) for Wet AMD

Tuesday, July 18, 2023

Clearside Biomedical, Inc. (Nasdaq: CLSD) is a biopharmaceutical company focused on revolutionizing the delivery of therapies for eye conditions by utilizing the suprachoroidal space (SCS®). The company recently announced the commencement of enrollment and dosing of participants in the ODYSSEY clinical trial. This Phase 2b trial aims to evaluate the efficacy of CLS-AX (axitinib injectable suspension) in treating neovascular age-related macular degeneration (wet AMD) by delivering the medication through Clearside's patented SCS Microinjector®.

According to George Lasezkay, Pharm.D., J.D., Clearside's President and Chief Executive Officer, the ODYSSEY trial is off to a promising start, with multiple U.S.-based clinical sites activated, and several participants already enrolled. The trial will randomly assign participants to receive either CLS-AX (1 mg) or aflibercept (2 mg) one month after the first loading dose of aflibercept. The study builds on the positive data from the previous OASIS trial, where a notable percentage of participants went for extended periods without additional treatment.

CLS-AX is a potent tyrosine kinase inhibitor designed to be administered into the suprachoroidal space behind the patient's visual field. Clearside believes that CLS-AX's broad VEGF blockade may offer advantages over existing retinal therapies by targeting a different level of the angiogenesis cascade. This delivery method has shown promise in preclinical studies and the Phase 1/2a wet AMD clinical trial, demonstrating a favorable safety profile and potential benefits for patients who may not optimally respond to current treatments. By utilizing the suprachoroidal administration of axitinib, the aim is to achieve targeted and prolonged drug delivery to affected tissue layers while minimizing drug exposure to the front of the eye.

The ODYSSEY trial is a randomized, double-masked, parallel-group, active-controlled, multi-center study involving 60 participants with wet AMD. The treatment period will last 36 weeks, with 40 participants receiving CLS-AX and 20 participants receiving aflibercept. The trial's primary outcome measure will assess the mean change in best corrected visual acuity, and secondary measures will include changes in visual function and ocular anatomy, the need for additional treatment, and treatment burden measured by total injections over the trial duration.

Age-related macular degeneration (AMD) is a condition that progressively leads to central vision loss and is the primary cause of legal blindness in people over 55 years old. Wet AMD, characterized by abnormal blood vessels leaking fluid or blood into the macula, is the leading cause of vision loss among patients with AMD. Current treatments require frequent injections, leading to a significant treatment burden for patients.

Clearside's Suprachoroidal Space (SCS®) Injection Platform and SCS Microinjector® offer a unique approach by providing unprecedented access to the back of the eye, where sight-threatening diseases often occur. The proprietary SCS Microinjector® system allows targeted delivery of various drug candidates into the suprachoroidal space, potentially improving efficacy and minimizing toxic effects on healthy cells.

Overall, Clearside Biomedical's ODYSSEY trial and the development of CLS-AX represent significant advancements in the treatment of wet AMD, with the potential to improve patient outcomes and reduce the treatment burden associated with current therapies.

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