Adverum Biotechnologies Initiates ARTEMIS Phase 3 Study Evaluating Ixo-vec for Wet AMD

Core Insights - Adverum Biotechnologies has initiated the ARTEMIS Phase 3 study to evaluate the efficacy and safety of Ixo-vec for treating wet age-related macular degeneration (AMD) [1][4] - The trial aims to demonstrate that a single injection of Ixo-vec is non-inferior to the standard treatment with aflibercept, potentially transforming the treatment landscape for wet AMD patients [5][10] Company Overview - Adverum Biotechnologies is a clinical-stage company focused on gene therapy to treat prevalent ocular diseases, aiming to establish a new standard of care [11][12] - The company is developing Ixo-vec, a one-time gene therapy designed to deliver long-term efficacy and reduce the burden of frequent anti-VEGF injections for wet AMD patients [10][11] Study Design - The ARTEMIS trial is a randomized, double-masked, sham-controlled study involving approximately 284 patients, including both treatment-naïve and previously treated individuals [7][8] - The primary endpoint is the mean change in best corrected visual acuity (BCVA) from baseline at one year, with a non-inferiority margin of -4.5 letters [2][8] Treatment Context - Wet AMD affects around 20 million individuals globally and is a leading cause of blindness in those over 65 years of age [9] - Current treatment requires frequent injections, with up to 42% of patients discontinuing treatment after two years, leading to poor long-term vision outcomes [4][9] Ixo-vec Characteristics - Ixo-vec utilizes a proprietary vector for a one-time intravitreal injection, aiming to provide stable therapeutic levels of anti-VEGF and improve patient compliance [10][11] - The therapy has received Fast Track and Regenerative Medicine Advanced Therapy designations from the FDA, indicating its potential as a transformative treatment option [10]