Clearside Biomedical has shared positive topline findings from its ODYSSEY Phase 2b trial of Suprachoroidal CLS-AX in wet AMD

2 min read | October 09, 2024 05:30 AM PDT | By Team Kalkine Media

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Clearside Biomedical has shared positive topline findings from its ODYSSEY Phase 2b trial of Suprachoroidal CLS-AX in wet AMD — Image source: Shutterstock

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Highlights:

The ODYSSEY Phase 2b trial of CLS-AX demonstrated stable visual acuity and anatomical control over nine months.
The trial showed a positive safety profile with no ocular or treatment-related serious adverse events reported.
A significant 67% of participants receiving CLS-AX did not require additional treatment within six months, resulting in an 84% reduction in treatment burden.

Clearside Biomedical {NASDAQ:CLSD} has announced encouraging topline results from its ODYSSEY Phase 2b trial of CLS-AX, a treatment for wet age-related macular degeneration (AMD). The trial successfully met all primary and secondary endpoints, showcasing the treatment's effectiveness in maintaining stable visual acuity and anatomical control over a nine-month period.

The safety profile of CLS-AX was notably positive, with no serious ocular or treatment-related adverse events reported during the study. This finding is critical for establishing the treatment's viability for patients requiring long-term management of wet AMD.

Additionally, the trial revealed that 67% of participants treated with CLS-AX did not require any additional treatments up to six months after the initial administration. This outcome resulted in an impressive 84% reduction in treatment burden for patients, indicating a significant improvement in the overall treatment experience.

CLS-AX is delivered using Clearside's proprietary SCS Microinjector®, which allows for targeted delivery and may offer flexible maintenance dosing intervals of three to six months. Based on the promising outcomes of the ODYSSEY trial, Clearside plans to advance the CLS-AX program into Phase 3 development.

These results position CLS-AX as a potential breakthrough in the treatment landscape for wet AMD, reflecting Clearside Biomedical’s commitment to innovating therapies that enhance patient outcomes in ophthalmology. As the company moves forward with Phase 3 preparations, the focus will be on further validating the efficacy and safety of CLS-AX in a larger patient population.

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