Suprachoroidal axitinib for wet AMD safe in phase 1/2a trial
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SEATTLE — Suprachoroidal axitinib had an “excellent” safety profile at all doses in the treatment of wet age-related macular degeneration, with early signs of durability and reduction in treatment burden, a speaker said here.
“Tyrosine kinase inhibitors are an exciting new molecular target in the treatment of neovascular AMD,” Rahul N. Khurana, MD, said at the American Society of Retina Specialists annual meeting. “Our current treatments target the extracellular VEGF-A and -B, which have excellent efficacy. However, there can be an upregulation of VEGF-C and -D, which may limit the efficacy of our current treatments.”
Khurana said axitinib works farther downstream, inhibiting VEGF receptors 1, 2 and 3.
CLS-AX (Clearside Biomedical) is an axitinib suspension that can be injected into the suprachoroidal space and is under investigation for the treatment of wet AMD.
Khurana and colleagues evaluated the safety and tolerability of CLS-AX in the OASIS phase 1/2a clinical trial and extension study. Patients had undergone at least two previous injections of an intravitreal anti-VEGF in the preceding 4 months and had persistent active disease.
Patients received 2 mg of aflibercept in the study eye at the first visit and then one treatment of CLS-AX 1 month later. The study included four dose-escalating cohorts: 0.03 mg (cohort 1), 0.1 mg (cohort 2), 0.5 mg (cohort 3) and 1 mg (cohort 4). Patients were followed monthly for 3 months in the primary study and up to 6 months in the extension study in cohorts 2, 3 and 4. Patients were assessed each month and given aflibercept as needed.
Suprachoroidal CLS-AX had an “excellent” safety profile in all 27 patients dosed in OASIS, Khurana said. There were no serious adverse events, no inflammation and no vasculitis.
At 6 months, there was an 80% reduction in treatment burden in cohort 2, an 85% reduction in cohort 3 and a 77% reduction in cohort 4.
Visual acuity was maintained over 6 months in cohorts 3 and 4 even though only one rescue injection was given for this group. Those cohorts also had stable central subfield thickness from baseline through 6 months despite the decrease in the number of treatments.
“CLS-AX is now being evaluated in a phase 2b clinical trial, the ODYSSEY study, for neovascular AMD,” Khurana said.
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Khurana RN. Safety and tolerability of suprachoroidal injection of CLS-AX in neovascular AMD patients with persistent activity following anti-VEGF therapy. Presented at: American Society of Retina Specialists annual meeting; July 28-Aug. 1, 2023; Seattle.
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