Adverum Biotechnologies, Inc. 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 at the 47th Annual Meeting of the Macula Society. The presentation titled "Ixoberogene soroparvovec (Ixo-vec) Intravitreal Gene Therapy for Neovascular Age-Related Macular Degeneration: Preliminary Results from the LUNA Phase 2 Study" is scheduled for 10:56am ET.

Visual (BCVA) and Anatomic (CST) Outcomes: Visual acuity was maintained at both dose levels - mean BCVA change from baseline to last visit (95% CI): 2E11: -1.7 (-4.5, 1.2); 6E10: +0.5 (-2.2, 3.3); Anatomic endpoints were maintained at both dose levels - means CST (mm) change from baseline to last visit; 2E11: -16.4 (-31.5, -1.3); 6E10: -7.9 (-30.9, 15.0); 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.

LUNA 26-week interim analysis expected mid-2024; Continued FDA and EMA formal and informal regulatory interactions; Initiation of Phase 3 trial expected H1'25.