Adverum Biotechnologies Announces Positive Preliminary Efficacy and Safety Data from LUNA Phase 2 Trial of Ixo-vec in Patients with Wet AMD

Core Insights - Adverum Biotechnologies announced promising preliminary safety and efficacy data from the LUNA Phase 2 trial for Ixo-vec, a gene therapy for wet age-related macular degeneration (AMD) [1][2][3] Efficacy and Safety Data - Both dose levels (2E11 and 6E10) showed potential best-in-class clinical activity, maintaining visual acuity and anatomic endpoints while reducing treatment burden [1][5] - Preliminary safety data indicate a favorable benefit-risk profile, with no serious adverse events related to Ixo-vec reported [1][6] - The majority of patients on the prophylactic regimen experienced no inflammation, with over 90% having no or minimal inflammation [1][6] Treatment Burden Reduction - At 26 weeks, Ixo-vec demonstrated a 90% reduction in annualized anti-VEGF injection rates at the 6E10 dose and a 94% reduction at the 2E11 dose [6] - Injection-free rates were 68% at 6E10 and 85% at 2E11 [6] - Visual acuity was maintained across both doses, with mean changes from baseline indicating stability [6] Upcoming Milestones - The 26-week interim analysis of the LUNA trial is expected in mid-2024, with plans to initiate a Phase 3 trial in the first half of 2025 [7] Background on Wet AMD - Wet AMD is a leading cause of blindness in individuals over 65, affecting approximately 20 million people globally, with projections indicating significant growth in cases as populations age [10][11]