Adverum Biotechnologies has launched the ARTEMIS Phase 3 study, a pivotal trial evaluating the efficacy and safety of a single intravitreal injection of Ixo-vec (ixoberogene soroparvovec) for wet age-related macular degeneration (AMD). The study compares Ixo-vec to the current standard of care, aflibercept administered every eight weeks, in approximately 284 patients, encompassing both treatment-naïve and previously treated individuals. The primary endpoint is non-inferiority in best corrected visual acuity at one year.
This trial holds substantial implications for the treatment landscape of wet AMD. Current treatments require frequent injections, placing a considerable burden on patients and healthcare systems. A successful outcome for Ixo-vec could offer a significant improvement in patient care by reducing the need for ongoing injections, potentially improving long-term vision outcomes and adherence to treatment. This would be a major advancement for a disease projected to impact millions more people globally by 2040.
ARTEMIS is the first of two planned Phase 3 registrational trials for Ixo-vec in wet AMD. The study is designed as a randomized, double-masked, sham-controlled trial including both treatment-naïve and previously treated patients. This inclusive design aims to generate data representative of real-world patient demographics and address the needs of a broad patient population, including those with the highest treatment burden. All participants will receive three loading doses of aflibercept before administration of Ixo-vec or sham treatment. Supplemental aflibercept injections will be available for all patients, along with prophylactic steroid eye drops.
The initiation of the ARTEMIS trial represents a crucial step toward potentially establishing Ixo-vec as a one-time treatment for wet AMD. Positive results could significantly disrupt the current treatment paradigm, offering patients a more convenient and potentially more effective long-term solution. This advancement could lead to better vision outcomes, improved quality of life for patients, and a reduced burden on healthcare providers. The results of ARTEMIS will be highly anticipated, as they could herald a new era in the management of this prevalent and debilitating eye disease.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
