Adverum Biotechnologies announced the initiation of the ARTEMIS phase 3 study to evaluate the efficacy and safety of Ixo-vec (ixoberogene soroparvovec) as a one-time intravitreal (IVT) injection for patients with neovascular (wet) age-related macular degeneration (AMD). In a press release, the company describes Ixo-vec as “a potential best-in-class one-time gene therapy designed to deliver long-term efficacy, reduce the burden of frequent anti-VEGF and improve vision outcomes for patients with wet AMD.”

ARTEMIS is a US-based study evaluating a single administration of Ixo-vec (6E10 vg/eye) compared to aflibercept (2 mg) every 8 weeks in approximately 284 patients with wet AMD, including both treatment-naïve and previously treated patients. The primary endpoint is mean change from baseline in best-corrected visual acuity (BCVA) at 1 year (average of weeks 52 and 56) with a non-inferiority (NI) margin of -4.5 letters. Per FDA guidance, the company said, all patients will receive 3 loading doses of aflibercept prior to receiving Ixo-vec. Patients in both arms will be eligible for supplemental injections of aflibercept and will receive prophylactic steroid eye drops.  

ARTEMIS is the first of 2 planned phase 3 registrational trials to evaluate Ixo-vec in patients with wet AMD. Details on the second study, named AQUARIUS and to be conducted globally, will be forthcoming, the company said.