Clearside Biomedical, Inc announced the release of positive 6-month data from its extension study of the OASIS phase 1/2a clinical trial evaluating CLS-AX, administered by suprachoroidal injection via Clearside’s proprietary SCS Microinjector, for the treatment of patients diagnosed with neovascular age-related macular degeneration (wet AMD).
The data includes both the 3-month dose-escalation period and 3-month extension study.
Tell me about CLS-AX.
CLS-AX (axitinib injectable suspension) is a tyrosine kinase inhibitor (TKI) currently approved to treat renal cell cancer. It achieves pan-VEGF blockade by directly inhibiting VEGF receptors-1, -2, and -3 with high potency and specificity. With suprachoroidal administration of axitinib, there is the potential to achieve prolonged duration and targeted delivery to affected tissue layers.
Watch the video below for a demonstration.
What happened in the OASIS trial?
Researchers reported positive data. Read the results here.
Back to the Extension Study … talk about the results.
Among the 12 participants in cohorts 3 and 4, there was a 77% to 85% reduction in treatment burden compared to the average number of monthly injections in the 6 months prior to receiving CLS-AX administration. Further, the number of patients not requiring additional therapy dropped from 92% at ≥ 3 months to 50% at > 6 months.
No serious adverse events (AEs) or treatment emergent adverse events were reported (n=14) in all cohorts.
Is that it?
Nope! CLS-AX also showed a stable mean best-corrected visual acuity (BCVA) and stable mean central subfield thickness (CST) at the 6-month mark.
What’s next?
Clearside is planning on launching the ODYSSEY phase 2 clinical trial, which will be a multicenter, randomized, double-masked phase 2b trial assessing an estimated 110 treatment-naïve patients with wet AMD.