Clearside Biomedical Completes Dosing in Cohort 2 of Phase 1/2a Clinical Trial of CLS-AX in Wet AMD Patients

Clearside Biomedical announced completion of dosing in Cohort 2 of OASIS, its ongoing phase 1/2a clinical trial of CLS-AX (axitinib injectable suspension) in patients with wet age-related macular degeneration (AMD).

OASIS is a U.S.-based, multicenter, 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. All Cohort 2 patients have received aflibercept at their first visit and a single dose of CLS-AX at their second visit 1 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 completed our enrollment and dosing of Cohort 2 patients after the promising safety and tolerability results from Cohort 1,” Thomas A. Ciulla, MD, MBA, Chief Medical Officer and Chief Development Officer, said in a company news release. “All patients in Cohort 2 have now received both their aflibercept and CLS-AX doses and will be monitored monthly by their physicians for the next 3 months. We believe that by combining the pan-VEGF attributes of axitinib with our proprietary CLS-AX formulation and delivery via our SCS Microinjector, we may facilitate an effective treatment option for patients suffering from wet AMD. We expect to report initial safety data from Cohort 2 by the end of this year.”

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.