Adverum Biotechnologies Announces Completion of Screening for Pivotal Phase 3 ARTEMIS Trial of Ixo-vec for Wet Age-Related Macular Degeneration

Core Insights - Adverum Biotechnologies is advancing its pivotal Phase 3 trial, ARTEMIS, for Ixo-vec in wet age-related macular degeneration (wet AMD), with full enrollment expected by 4Q 2025 and data readout anticipated in 1Q 2027 [1][6]. Company Overview - Adverum Biotechnologies is a clinical-stage company focused on gene therapy to treat prevalent ocular diseases, aiming to establish functional cures to restore vision and prevent blindness [4]. - The company is developing ixoberogene soroparvovec (Ixo-vec), designed for a one-time intravitreal injection, which aims to provide long-term efficacy and reduce the need for frequent anti-VEGF treatments [3][4]. Trial Details - ARTEMIS is the first of two Phase 3 trials evaluating Ixo-vec, comparing a single administration of Ixo-vec (6E10 vg/eye) to aflibercept (2mg) administered every 8 weeks [2]. - The trial includes both treatment-naïve and previously treated patients, with the goal of demonstrating the efficacy of Ixo-vec as a potential one-time treatment for wet AMD [2][3]. Regulatory Designations - Ixo-vec has received Fast Track and Regenerative Medicine Advanced Therapy (RMAT) designations from the FDA, as well as PRIME designation from the EMA and Innovation Passport from the UK's Medicines and Healthcare Products Regulatory Agency [3].