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Clearside Biomedical announces successful End-of-Phase 2 meeting for CLS-AX

Clearside Biomedical announces successful End-of-Phase 2 meeting for CLS-AX

Clearside Biomedical (CLSD) announced the receipt of the formal meeting minutes from its recent End-of-Phase 2 meeting with the U.S. Food and Drug Administration relating to CLS-AX for the treatment of neovascular age-related macular degeneration. CLS-AX combines the flexible dosing of a biologic with the longer duration of a tyrosine kinase inhibitor and is administered via suprachoroidal injection utilizing Clearside’s patented SCS Microinjector. “We are pleased to report the positive outcome of our End-of-Phase 2 meeting with the FDA,” said George Lasezkay, PharmD, JD, President and Chief Executive Officer. “With a positive safety profile, extended duration, and proven re-dosing capability, CLS-AX has the potential to provide a compelling alternative in the $12+ billion wet AMD market. We look forward to highlighting our proposed Phase 3 program during our upcoming earnings call later this month.”

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