Clearside Biomedical, Inc. announced today positive results from its OASIS Phase 1/2a clinical trial of CLS-AX (axitinib injectable suspension) administered by suprachoroidal injection via Clearside’s SCS Microinjector in (wet AMD) patients.
Tell me about CLS-AX.
CLS-AX Axitinib is a tyrosine kinase inhibitor (TKI) currently approved to treat renal cell cancer. It achieves pan-VEGF blockade bydirectly 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. (via)
Tell me about the study.
The OASIS phase 1/2a trial (NCT04626128) included 4 cohorts with 27 total participants, all of whom had previous wet AMD treatment experience and active disease at screening.
Eligible patients were those who demonstrated stable visual acuity following two or more previous injections with an intravitreal anti-VEGF agent.
Patients received aflibercept at the first visit, followed by a single dose of CLS-AX (dose dependent on their cohort) at the second visit one month later.
What did the results show?
The primary safety endpoint was achieved. CLS-AX was well tolerated and demonstrated a positive safety profile across all time points and doses. Signs of biologic effect with stable mean best-corrected visual acuity (BCVA) and stable mean central subfield thickness (CST) were also observed.
Let’s talk numbers.
In OASIS cohorts 3 and 4, to the 3-month time point (n=16), 69% of patients did not receive additional therapy, 92% of patients did not receive additional therapy per protocol criteria, and there was a 73% reduction in treatment burden from the average monthly injections in the 3 months before CLS-AX administration.
Any adverse events?
There were no serious adverse events (AEs) across all cohorts, no treatment-emergent AEs, no dose-limiting toxicities, and no AEs related to inflammation, vasculitis, or vascular occlusion.
What’s the significance?
CLS-AX has the potential to treat retinal diseases with a repeatable, reliable, and validated in-office delivery approach.