Clearside Biomedical Announces Completion of Final Participant Visit in ODYSSEY Phase 2b Trial of CLS-AX in Wet AMD Page 1

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 via the suprachoroidal space (SCS), announced the completion of the last 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 achieved, the study database will be cleaned and verified. The database will then be locked and unblinded data will be analyzed. Topline results are expected to be reported the week of October 7, 2024.

“The completion of our ODYSSEY study is a significant achievement for Clearside, and I would like to thank the Clearside team for their hard work and dedication in conducting the study and achieving this important milestone,” said George Lasezkay, Pharm.D., JD, President and Chief Executive Officer. “We would also like to express our sincere appreciation to the participants, clinical sites and 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 administration into the suprachoroidal space using our proprietary SCS Microinjector. We look forward to reporting the topline data and also presenting the data at events leading up to the American Academy of Ophthalmology (AAO) Annual Meeting in Chicago.”

About the ODYSSEY Phase 2b Clinical Trial

ODYSSEY is a randomized, double-blind, parallel-group, active-controlled, multicenter, 36-week Phase 2b clinical trial in participants with wet AMD. A total of 60 participants were expected to receive 36 weeks of treatment and would be randomized to CLS-AX (1 mg) or aflibercept (2 mg) with a 2:1 randomization schedule (40 participants in the CLS-AX arm and 20 participants in the aflibercept arm). CLS-AX was administered by suprachoroidal injection via Clearside’s SCS Microinjector, and aflibercept was administered by 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 is the mean change from baseline in best-corrected visual acuity. Secondary outcomes included other changes from baseline in visual function and ocular anatomy, the need for additional treatment, and treatment burden as measured by the total number of injections over the duration of the study. 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 at clinicaltrials.gov (NCT05891548).

Diskutieren Sie über die entaltenen Werte