Adverum Biotechnologies (NASDAQ:ADVM) announced topline 52-week results from its LUNA Phase 2 trial, new four-year long-term follow-up data from its OPTIC study, and key design elements for its pivotal program.
Both the LUNA and OPTIC trials were designed to evaluate a broad wet AMD population, including patients with severe, hard-to-treat disease who required frequent anti-VEGF injections prior to enrollment.
“We are thrilled to report 52-week LUNA data and four-year OPTIC data that continue to support Ixo-vec as a transformative and potential best-in-class therapy, which may provide patients who have wet AMD with potentially life-long benefit and a predictable safety profile,” said Laurent Fischer, MD, president and CEO of Adverum. “Both OPTIC 2E11 results and LUNA efficacy data at 52 weeks show maintenance of visual and anatomic endpoints with over 80% reduction in injection burden and greater than 50% injection freedom. These consistent results are bolstered by our OPTIC long-term data where we have demonstrated stable therapeutic aflibercept levels through five years. The data across both studies support a reliable long-term benefit and a predictable safety profile.”
Dr. Fischer added, “Ultimately, Ixo-vec is a potential paradigm-shifting solution for patients with wet AMD, where real-world evidence suggests that up to 57% of patients stop anti-VEGF treatment within five years, and the vast majority of patients end up losing vision. Designed as a single, one-time intravitreal injection, Ixo-vec has the potential to extend therapeutic benefit from weeks to years. Today’s four-year OPTIC data suggest that Ixo-vec may preserve vision for the life of wet AMD patients.”
