Adverum Biotechnologies reports results of two trials of Ixo-vec in AMD

Adverum Biotechnologies (ADVM) announced topline 52-week results of Ixo-vec from the LUNA Phase 2 trial, new 4-year OPTIC long-term follow-up data and key pivotal program design elements. LUNA is an ongoing Phase 2 trial. 60 patients with wet AMD were randomized equally across two dose cohorts. LUNA is designed to inform the selection of both the Ixo-vec dose and prophylactic regimen for Phase 3 registrational trials. OPTIC is an ongoing, dose-ranging first-in-human trial. 30 patients with wet AMD requiring frequent IVT injections were enrolled equally across two doses. Both LUNA and OPTIC were designed to assess a broad wet AMD population, including hard-to-treat patients. The 52-week LUNA data combined with follow-up from OPTIC at 4 years continue to support long-term potential best-in-class product profile of Ixo-vec. The 6E10 dose in LUNA maintains visual and anatomic endpoints and demonstrates potential best-in-class injection-free rates and reduction in injection burden. No LUNA patients who received local steroid prophylaxis had inflammation at week 52 or at any subsequent visit, and 100% of OPTIC 2E11 patients were free of inflammation at year 1 and through year 4. The 6E10 dose cohort with steroid eye drops or topical steroids to progress into two registrational studies; initial ARTEMIS Phase 3 non-inferiority study will evaluate a broad patient population; on track and expected to initiate in 1H 2025.