Clearside Biomedical Completes Recruitment in ODYSSEY Phase 2b Clinical Trial of CLS-AX in Wet AMD

- Successful Completion of Recruitment Driven by Strong Clinical Site Participation and Investigator Support -

- Topline Data Expected in Q3 2024 -

ALPHARETTA, Ga., Nov. 01, 2023 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS), announced today the completion of recruitment in its ODYSSEY Phase 2b clinical trial, a randomized, double-masked, parallel-group, active-controlled, multi-center study in participants with neovascular age-related macular degeneration (wet AMD). ODYSSEY is evaluating the safety and efficacy of CLS-AX (axitinib injectable suspension), a highly potent tyrosine kinase inhibitor delivered directly to the site of disease via Clearside’s SCS Microinjector.

Following the completion of recruitment, final participants will be randomized to the CLS-AX treatment arm or the aflibercept comparator arm by the middle of December 2023. The Company expects to report topline data in the third quarter of 2024.

“The completion of recruitment in ODYSSEY is a critical achievement for Clearside as we strive to bring an improved therapy to the millions of individuals living with wet AMD, a common cause of legal blindness in individuals over age 55,” said, George Lasezkay, Pharm.D., J.D., President and Chief Executive Officer. “The efficacy and safety results from the study will guide the path forward for our pivotal Phase 3 development program for CLS-AX. We would like to thank the clinical trial participants, investigators, and sites whose significant interest in CLS-AX drove strong recruitment for the study as we pursue the common goal of improving treatment for wet AMD.”

“In ODYSSEY, we are looking to replicate the excellent safety profile, stable vision, and reduced frequency of injections we observed in our OASIS Phase 1/2a trial and its 3-month Extension Study. The differentiated mechanism of action and high potency of axitinib combined with safe and reliable delivery into the suprachoroidal space with our proprietary SCS Microinjector has the potential to be a best-in-class approach for long-term maintenance therapy for wet AMD patients,” concluded Dr. Lasezkay.