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 [2][5] Study Design - ARTEMIS is a US-based, randomized, double-masked, sham-controlled trial involving approximately 284 patients, including both treatment-naïve and previously treated individuals [2][7] - 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] - All participants will receive three loading doses of aflibercept before administration of Ixo-vec [2][8] Significance of Ixo-vec - Ixo-vec is positioned as a potential best-in-class gene therapy that could provide long-term efficacy and reduce the treatment burden associated with frequent anti-VEGF injections [5][10] - The therapy is designed for a one-time intravitreal injection, which is expected to optimize patient compliance and improve vision outcomes [10][11] Unmet Medical Need - There is a significant unmet need for longer-acting therapies for wet AMD, with data indicating that up to 42% of patients discontinue treatment after two years, leading to poor long-term vision outcomes [4][9] - The current standard of care requires lifelong repeated injections, highlighting the potential impact of Ixo-vec in reducing treatment frequency [9][10] Regulatory Designations - Ixo-vec has received Fast Track and Regenerative Medicine Advanced Therapy (RMAT) designations from the FDA, as well as PRIME designation from the EMA [10][11]