Clearside Biomedical completes final participant visit in ODYSSEY Phase 2b clinical trial of CLS-AX

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Clearside Biomedical has completed the final participant visit in the ODYSSEY Phase 2b clinical trial of CLS-AX (axitinib injectable suspension) in neovascular age-related macular degeneration (wet AMD).

According to the company’s press release1, the next step for is for the database from this study to be cleaned and verified. Following this, the database will be locked and the unblinded data will be analyzed.

George Lasezkay, PharmD, JD, is the President and Chief Executive Officer of Clearside Biomedical. In a release1, he shared his thoughts on this milestone and the future for this research, saying. “The completion of our ODYSSEY trial represents a major accomplishment for Clearside and I would like to recognize the Clearside team for the hard work and dedication in conducting the trial and achieving this important milestone. We would also like to extend our sincere appreciation to the participants, clinical sites, and the physician investigators involved in ODYSSEY. At Clearside, we believe there is a compelling market opportunity for CLS-AX to provide patients and physicians with a potentially safer treatment option and reduced treatment burden using axitinib, the highly-potent tyrosine kinase inhibitor (TKI), combined with delivery into the suprachoroidal space using our patented SCS Microinjector®. We look forward to reporting the topline data and also presenting the data at events ahead of the annual meeting of the American Academy of Ophthalmology (AAO) in Chicago.”

Topline results are expected during the week of October 7, 2024.¹

Reference:

1. Clearside Biomedical Announces Completion of Final Participant Visit in ODYSSEY Phase 2b Trial of CLS-AX in Wet AMD. Clearside Biomedical, Inc. August 27, 2024. Accessed August 30, 2024. https://www.biospace.com/clearside-biomedical-announces-completion-of-final-participant-visit-in-odyssey-phase-2b-trial-of-cls-ax-in-wet-amd