{"id":822433,"date":"2025-03-06T07:10:56","date_gmt":"2025-03-06T12:10:56","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/clearside-biomedical-announces-successful-end-of-phase-2-meeting-with-the-fda-and-alignment-on-phase-3-plans-for-suprachoroidal-cls-ax-in-wet-amd\/"},"modified":"2025-03-06T07:10:56","modified_gmt":"2025-03-06T12:10:56","slug":"clearside-biomedical-announces-successful-end-of-phase-2-meeting-with-the-fda-and-alignment-on-phase-3-plans-for-suprachoroidal-cls-ax-in-wet-amd","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/clearside-biomedical-announces-successful-end-of-phase-2-meeting-with-the-fda-and-alignment-on-phase-3-plans-for-suprachoroidal-cls-ax-in-wet-amd\/","title":{"rendered":"Clearside Biomedical Announces Successful End-of-Phase 2 Meeting with the FDA and Alignment on Phase 3 Plans for Suprachoroidal CLS-AX in Wet AMD"},"content":{"rendered":"
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\n – CLS-AX Phase 3 Program Designed to Maximize Commercial Potential in Wet AMD –<\/em>\n <\/p>\n

\n – Flexible Dosing and Extended Duration would be Important Differentiators from Existing Approved Therapies and Other Tyrosine Kinase Inhibitors in Development –<\/em>\n <\/p>\n

ALPHARETTA, Ga., March 06, 2025 (GLOBE NEWSWIRE) — Clearside Biomedical, Inc.\u00a0(Nasdaq: CLSD) (\u201cClearside\u201d or the \u201cCompany\u201d), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS\u00ae<\/sup>), announced today the receipt of the formal meeting minutes from its recent End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) relating to CLS-AX (axitinib injectable suspension) for the treatment of neovascular age-related macular degeneration (wet AMD). CLS-AX combines the flexible dosing of a biologic with the longer duration of a tyrosine kinase inhibitor (TKI) and is administered via suprachoroidal injection utilizing Clearside\u2019s patented SCS Microinjector\u00ae<\/sup>.<\/p>\n

\u201cWe are pleased to report the positive outcome of our End-of-Phase 2 meeting with the FDA,\u201d said George Lasezkay, PharmD, JD, President and Chief Executive Officer. \u201cWith 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.\u201d<\/p>\n

Victor Chong, MD, MBA, Chief Medical Officer and EVP, Head of Research and Development, commented, \u201cOur interactions with the FDA have been very positive and productive and we are aligned on our proposed Phase 3 program. Recognizing that wet AMD patients require individualized treatment schedules, our proposed Phase 3 trials are designed to support a flexible maintenance dosing label of CLS-AX for every 3 to 6 months as needed based on patient disease assessments by the physician.\u201d<\/p>\n

The meeting and formal minutes confirmed key elements for two proposed Phase 3, non-inferiority, pivotal trials, including agreement on the protocol design, patient population, primary and secondary endpoints, and use of sham injections.<\/p>\n

CLS-AX Proposed Phase 3 Program Highlights:<\/p>\n