Clearside Biomedical presented key data from Phase 1/2a OASIS trial

Clearside Biomedical announced that key data from the Phase 1/2a OASIS clinical trial were presented at The Retina Society 56th Annual Scientific Meeting. The results of the trial demonstrate the key benefits of Clearside’s patented suprachoroidal delivery platform and its lead drug candidate, CLS-AX being developed for the treatment of neovascular age-related macular degeneration. The presentation, entitled, “Safety and Tolerability of CLS-AX via Suprachoroidal Injection in nAMD Patients with Persistent Activity Following Anti-VEGF Therapy” was delivered by David M. Brown, MD, Retina Consultants of Texas. Dr. Brown’s presentation summarized the data from Clearside’s 3-month Phase 1/2a OASIS clinical trial and Extension Study through 6 months. Axitinib was described as a highly potent, pan-VEGF TKI to treat wet AMD which has shown 10x more potency than other TKS in preclinical studies. The advantages of suprachoroidal delivery directly targeting the site of disease at the back of the eye were featured through multiple preclinical studies comparing equivalent doses of axitinib injected suprachoroidally versus intravitreally. In the OASIS and Extension Study, participants with wet AMD who were sub-responders with active disease at screening were followed for up to 6 months after CLS-AX treatment. This patient population is important because enrolling difficult to treat anti-VEGF sub-responders allowed observation of possible signs of biologic effect while minimizing false signals. The studies demonstrated an excellent safety profile at all doses and timepoints with no serious adverse events, no dose limiting toxicities, and no adverse events from inflammation. In addition, signs of biologic effect with stable mean best corrected visual acuity and stable mean central subfield thickness to the 6-month timepoint were observed. Importantly, CLS-AX exhibited early signs of durability and reduction in treatment burden with a 77-85% reduction in injection frequency at higher doses in cohorts 3 and 4.