NEWS!!!Clearside Biomedical Announces U.S. FDA Acceptance of Investigational New Drug Application for CLS-AX (axitinib injectable suspension) Administered in Suprachoroidal Space
4:02 pm ET August 10, 2020 (Globe Newswire) Print
- Initiation of CLS-AX Phase 1/2a Clinical Trial in Wet AMD Targeted by Year-End 2020 -
Clearside Biomedical, Inc. (Nasdaq:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for CLS-AX (axitinib injectable suspension), enabling initiation of a Phase 1/2a clinical trial of CLS-AX in neovascular age-related macular degeneration (wet AMD) patients by the end of 2020.
"The FDA's acceptance of our IND submission for CLS-AX is a significant achievement for Clearside and demonstrates our ability to successful move another internally-developed program into the clinic," said George Lasezkay, Pharm.D., J.D., President and Chief Executive Officer. "As a tyrosine kinase inhibitor (TKI), axitinib has demonstrated pan-VEGF inhibition in independent studies and may have the potential to be more efficacious than current, more narrowly focused VEGF inhibition approaches. In our internal preclinical studies, CLS-AX delivered through suprachoroidal injection was well tolerated and showed durability over several months, providing Clearside the opportunity to potentially reduce treatment burden and address a primary need for wet AMD patients. We look forward to initiating clinical work by the end of 2020."
The Phase 1/2a clinical trial in wet AMD patients is expected to be an open-label, dose-escalation study to assess the safety and tolerability of single doses of CLS-AX administered through suprachoroidal injection following two or more prior treatments with an intravitreal anti-VEGF agent.
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