Clearside Biomedical announced completion of dosing in the first cohort of OASIS, its ongoing Phase 1/2a clinical trial of CLS-AX (axitinib injectable suspension) in patients with neovascular age-related macular degeneration (wet AMD).
OASIS is a U.S.-based, multi-center, open-label, dose-escalation trial in wet AMD patients to assess the safety and tolerability of a single dose of CLS-AX administered by suprachoroidal injection. The first cohort of patients have received aflibercept at their first visit and a single dose of CLS-AX at their second visit one month later. The primary endpoint for the trial will assess the safety and tolerability of CLS-AX for three months following the administration of CLS-AX.
“We are pleased to have made rapid progress enrolling patients in our OASIS trial evaluating the use of axitinib, a highly-potent small molecule tyrosine kinase inhibitor (TKI), administered by suprachoroidal injection,” said Thomas A. Ciulla, M.D., MBA, Chief Medical Officer and Chief Development Officer. “This progress was made possible through the combined efforts and commitment by patients, investigators, advisors and our internal team. We believe that by combining the high potency and pan-VEGF attributes of axitinib with our proprietary CLS-AX formulation and delivery via our SCS Microinjector®, we may extend the duration of therapeutic action and reduce or relieve the profound treatment burden for wet AMD patients. We expect to report initial safety data from this first cohort of patients in mid-2021 and continue on to a higher dose in the next cohort in the second half of the year.”
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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 effects 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.