Adverum Biotechnologies Launches Phase 3 Trial of Ixo-vec for Wet AMD

Adverum Biotechnologies, a clinical-stage company based in Redwood City, California, has announced the commencement of the ARTEMIS Phase 3 study, which aims to evaluate the efficacy and safety of Ixo-vec (ixoberogene soroparvovec) for the treatment of neovascular (wet) age-related macular degeneration (AMD). This critical study indicates a significant step forward in the use of gene therapy as a potential solution for highly prevalent ocular diseases.

The ARTEMIS Phase 3 trial is a US-based study designed to assess a one-time intravitreal injection of Ixo-vec in comparison to bi-monthly injections of aflibercept in patients with wet AMD. Approximately 284 participants, including those who are new to treatment as well as those with prior treatment experience, will be enrolled in this randomized trial. The primary aim is to determine the change in best corrected visual acuity (BCVA) from baseline at the one-year mark, with a non-inferiority margin set at -4.5 letters. Following FDA guidelines, all patients will receive three loading doses of aflibercept before being administered Ixo-vec. Supplementary aflibercept injections and prophylactic steroid eye drops will be available to patients in both arms of the study.

ARTEMIS is one of two crucial Phase 3 trials planned to assess Ixo-vec's potential. Details about the second trial, named AQUARIUS and set to be conducted globally, will be revealed later. This initiative underscores the company's commitment to revolutionizing the treatment landscape for wet AMD with a single injection solution that could restore vision and prevent blindness.

Laurent Fischer, M.D., President and CEO of Adverum Biotechnologies, expressed that the initiation of the ARTEMIS trial highlights the company’s dedication to transforming ocular treatments. With significant experience in the field, Adverum positions Ixo-vec as a leading therapy offering potential lifelong benefits to patients who currently rely on frequent injections to maintain their sight.

Rabia Gurses Ozden, M.D., Chief Medical Officer at Adverum, emphasized that the ARTEMIS trial was crafted to maximize potential clinical and regulatory success. The trial's design, which includes both treatment-naïve and previously treated patients, aligns with the real-world patient demographics, potentially expediting enrollment and creating a representative dataset.

The challenge of providing longer-acting anti-VEGF therapies remains significant, as recent data indicate that a large percentage of wet AMD patients cease treatment after two years, leading to poor long-term vision outcomes. Ixo-vec aims to address this issue by reducing the treatment burden and providing lifelong injection freedom, which could significantly benefit many wet AMD patients.

The ARTEMIS trial also includes insights from various investigators involved in the study. Dr. Dante Pieramici, Medical Director of Research at California Retina Consultants, highlighted strong patient interest in a one-time treatment option like Ixo-vec. Dr. Sean Adrean of Retina Consultants of Orange County lauded the inclusion of diverse patient populations in the study, which may yield informative data about Ixo-vec's performance among patients with heavy injection burdens. Dr. Carl Danzig from Rand Eye Institute noted that early trials demonstrated Ixo-vec's ability to maintain therapeutic levels of aflibercept with an acceptable safety profile.

Wet AMD is a significant cause of vision loss in adults over 65, affecting millions globally. As the population ages, the incidence of wet AMD is expected to rise. Current treatments typically require frequent anti-VEGF injections. The gene therapy approach represented by Ixo-vec promises a more stable and potentially lifelong solution by delivering therapeutic levels of anti-VEGF to control macular fluid and reduce the frequency of injections.

Adverum Biotechnologies aims to redefine treatment paradigms for ocular diseases, aspiring to deliver a profound societal impact by preserving vision and improving quality of life for patients worldwide.