Retina Society 2023: Safety and Tolerability of CLS-AX Via Suprachoroidal Injection in Neovascular AMD Patients With Persistent Activity Following Anti-VEGF Therapy

Alejandra Maiz, MD
University of Michigan

Dr. David Brown of Retina Consultants of Texas in Houston presented safety and tolerability data of a single-dose of CLS-AX (axitinib injectable suspension). Touted by Dr. Brown as an injectable that delivers a drug directly to “where the money is” in the retina-RPE-choroid complex, this suprachoroidal-delivered tyrosine kinase inhibitor was trialed in patients with neovascular age-related macular degeneration (nAMD) who had undergone 2 or more previous intravitreal anti-VEGF injections in the preceding 4 months with persistently active disease and stable visual acuity. Upon enrollment, patients received a standard 2 mg injection of aflibercept followed by 1 dose of suprachoroidal CLS-AX 1 month later. Monthly follow-up was performed for 3 months (OASIS study) or up to 6 months (Extension Study). Indications for additional treatment with repeat aflibercept injections included: loss of ≥ 10 letters in best-corrected visual acuity (BCVA) with exudation, increase in central subfield thickness (CST) >75 microns, or a vision-threatening macular hemorrhage.

A total of 27 patients with a mean duration of nAMD diagnosis of 54 months and 29.9 prior anti-VEGF injections were treated in four dose-escalating cohorts (0.03 mg, 0.1 mg, 0.5 mg, 1.0 mg). Overall, the injection was well-tolerated and no serious adverse events occurred – including zero cases of endophthalmitis or uveitis. 67% (8/12 patients) of those with follow up out to 6 months did not require additional therapy. Mean BCVA and CST remained stable throughout the 6 month trial period.

Dr. Brown summarized his talk stating CLS-AX is safe and allows for extension between treatment intervals compared to current therapy options for patients who historically have not shown great response to our classic anti-VEGF agents. Phase 2 of the trial is ongoing and he is optimistic that at the annual Retina Society Meeting in 2024, 1-year data on a larger cohort of patients will be available for presentation.