Adverum Biotechnologies announces efficacy, safety data from LUNA Phase 2 trial

Adverum Biotechnologies announced preliminary safety and efficacy data from the ongoing LUNA Phase 2 trial in patients with wet age-related macular degeneration, AMD. These data are being presented by Dr. Arshad Khanani today at the 47th Annual Meeting of the Macula Society. LUNA Preliminary Efficacy and Safety Data Summary: Both the 2E11 and 6E10 doses demonstrated maintenance of visual and anatomic outcomes. Notably, both doses resulted in a potentially best-in-class reduction in annualized anti-vascular endothelial growth factor injections and the percentage of patients remaining free of annualized injections, with data trending similar to or better than the OPTIC study. Treatment Burden Reduction: At 26 weeks, Ixo-vec demonstrated annualized reduction in anti-VEGF injection rates of 90% at 6E10 and 94% at 2E11. At 26 weeks, Ixo-vec demonstrated injection free rates of 68% at 6E10 and 85% at 2E11. Visual and Anatomic Outcomes: Visual acuity was maintained at both dose levels. Anatomic endpoints were maintained at both dose levels. In a sub-group analysis of patients with higher baseline CST, a greater reduction in CST was demonstrated, indicating the robust efficacy potential of Ixo-vec gene therapy. Safety: Preliminary data suggest corticosteroid prophylaxis optimization at both the 2E11 and 6E10 doses appears to result in improved inflammatory profiles in LUNA as compared to OPTIC study results. Ixo-vec was generally well-tolerated, and when present intraocular inflammation was responsive to local corticosteroids. No Ixo-vec related serious adverse events were reported. No episcleritis, vasculitis, retinitis, choroiditis, vascular occlusion or hypotony were reported. Preliminary data indicate that select prophylactic regimens are outperforming others that do not provide sustained prophylaxis.