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    Clearside Biomedical Announces Completion of Final Participant Visit in ODYSSEY Phase 2b Trial of CLS-AX in Wet AMD

    - CLS-AX is a Highly Potent Tyrosine Kinase Inhibitor Delivered Suprachoroidally Using Clearside’s Proprietary SCS Microinjector -

    - Topline Data Expected to be Reported During the Week of October 7, 2024 -

    ALPHARETTA, Ga., Aug. 27, 2024 (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 the completion of the final participant visit in the Company’s ODYSSEY Phase 2b clinical trial of CLS-AX (axitinib injectable suspension) in neovascular age-related macular degeneration (wet AMD). With this milestone complete, the study database is being cleaned and verified. Then the database will be locked and the unblinded data will be analyzed, with topline results expected to be reported during the week of October 7, 2024.

    “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,” said George Lasezkay, Pharm.D., J.D., President and Chief Executive Officer. “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.”

    About the ODYSSEY Phase 2b Clinical Trial

    ODYSSEY is a randomized, double-masked, parallel-group, active-controlled, multi-center, 36-week Phase 2b clinical trial in participants with wet AMD. A total of 60 participants were expected to be treated for 36 weeks and randomized to either CLS-AX (1 mg) or aflibercept (2 mg) with a 2:1 randomization schedule (40 participants in CLS-AX arm and 20 participants in aflibercept arm). CLS-AX was administered by suprachoroidal injection via Clearside’s SCS Microinjector, and aflibercept was administered via intravitreal injection. Eligible participants were treatment-experienced and underwent diagnostic imaging at their screening visit followed by masked reading center confirmation of persistent active disease. The primary outcome measure is the mean change from baseline in best corrected visual acuity. Secondary outcome measures include other changes from baseline in visual function and ocular anatomy, the need for supplemental treatment, and treatment burden as measured by total injections over the trial duration. The trial is designed to provide the necessary parameters to design a Phase 3 program. Additional information about the Phase 2b trial can be found on clinicaltrials.gov (NCT05891548).

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    Clearside Biomedical Announces Completion of Final Participant Visit in ODYSSEY Phase 2b Trial of CLS-AX in Wet AMD - CLS-AX is a Highly Potent Tyrosine Kinase Inhibitor Delivered Suprachoroidally Using Clearside’s Proprietary SCS Microinjector - - Topline Data Expected to be Reported During the Week of October 7, 2024 - ALPHARETTA, Ga., Aug. 27, 2024 …