Clearside Biomedical presents safety, tolerability data from OASIS trial

Clearside Biomedical announced that safety and tolerability data from its recent OASIS clinical trial of CLS-AX were presented at the American Society of Retina Specialists 41st Annual Scientific Meeting. CLS-AX is a proprietary suspension formulation of the tyrosine kinase inhibitor axitinib that provides high potency pan-VEGF inhibition delivered via Clearside’s proprietary SCS Microinjector. The presentation, entitled, “Safety and Tolerability of Suprachoroidal Injection of CLS-AX in Neovascular AMD Patients With Persistent Activity After Anti-VEGF Therapy” was delivered by Rahul N. Khurana, MD, FACRS, Northern California Retina Vitreous Associates. Dr. Khurana presented data from Clearside’s OASIS Phase 1/2a clinical trial and Extension Study highlighting the excellent safety profile with no serious adverse events, no adverse events from inflammation, no vasculitis or vascular occlusion, and no treatment emergent adverse events related to study treatment. The presentation described the promising results from the 6-Month Extension Study at higher doses in Cohort 3 and Cohort 4. These cohorts showed signs of durability and a 77% – 85% reduction in treatment burden. Additionally, signs of biologic effect with stable mean best corrected visual acuity and stable mean central subfield thickness to the 6-month timepoint were seen in these cohorts. OASIS was an open-label, single dose-escalation Phase 1/2a trial in neovascular age-related macular degeneration. OASIS was a 3-month trial, followed by a 3-month Extension Study. The trial included four cohorts at the following doses: Cohort 1 at 0.03 mg; Cohort 2 at 0.1 mg; Cohort 3 at 0.5 mg; Cohort 4 at 1.0 mg. Participants from Cohorts 2, 3 and 4 who rolled over into the Extension Study were followed for a total of 6 months after a single dose of CLS-AX. Participants enrolled in OASIS were heavily anti-VEGF treatment experienced with active disease at screening, which was confirmed by an independent reading center.