Clearside Biomedical Announces FDA Acceptance of CLS-AX IND

Clearside Biomedical announced 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.

CLS-AX (axitinib injectable suspension) is a proprietary suspension of axitinib for suprachoroidal injection. Axitinib is a tyrosine kinase inhibitor (TKI) currently approved to treat renal cell cancer that achieves pan-VEGF blockade, directly inhibiting VEGF receptors-1, -2, and -3 with high potency and specificity. Clearside believes this broad VEGF blockade may have efficacy advantages over existing retinal therapies by acting at a different level of the angiogenesis cascade, and may benefit patients who sub-optimally respond to current more narrowly focused anti-VEGF therapies. Suprachoroidal injection of this proprietary suspension of axitinib has demonstrated meaningful potential in preclinical studies in multiple species. Preclinical results from Clearside and independent investigators have shown pharmacodynamic effect with reduced growth of experimental neovascularization and decreased fluorescein leakage. With suprachoroidal administration of axitinib, there is the potential to achieve prolonged duration and targeted delivery to affected tissue layers. Clearside is developing CLS-AX as a long-acting therapy for the treatment of wet AMD.