Adverum Biotechnologies Presents Additional Efficacy and Safety Data from the OP… – Press Release


– Poster highlights analysis of baseline neutralizing antibodies to AAV.7m8 and impact on ADVM-022 efficacy and safety in OPTIC –
– Reductions in mean annualized anti-VEGF injections ranged from 81% in all patients to 94% in those with NAbs <1:125 at 2 X 10^11 vg/eye –

REDWOOD CITY, Calif., May 01, 2022 (GLOBE NEWSWIRE) — Adverum Biotechnologies, Inc. ADVM, a clinical-stage gene therapy company targeting unmet medical needs in ocular and rare diseases, today announced the presentation of new post-hoc analysis from the OPTIC study of ADVM-022 in wet age-related macular degeneration (wet AMD) during The Association for Research in Vision and Ophthalmology (ARVO) 2022 Annual Meeting in Denver, Colorado and virtually.

The new data from OPTIC assessed the potential impact of baseline levels of neutralizing antibodies (NAbs) on efficacy and safety outcomes with ADVM-022 (AAV.7m8-aflibercept). It is a common practice for companies developing adeno-associated viruses (AAV) vector therapies to consider how the presence of pre-existing NAbs might influence treatment efficacy or safety parameters. In all subjects, a single intravitreal (IVT) injection gene therapy at the 2 X 10^11 vg/eye (2E11) dose demonstrated a greater than 80% reduction in annualized anti-vascular endothelial growth factor (VEGF) injections, as previously reported.   In subjects with baseline NAbs <1:125, the reductions in mean annualized injection frequency increased to 94%. There was no correlation between baseline NAbs and safety events.

“The data shows great promise of ADVM-022 for wet AMD patients regardless of baseline levels of neutralizing antibodies to AAV.7m8, and the potential to achieve even higher efficacy in those whose NAbs titers are below 1:125,” said Laurent Fischer, M.D., president and chief executive officer at Adverum Biotechnologies. “We are excited to share these results with the ophthalmology community at ARVO. We continue to plan for the initiation of a Phase 2 wet AMD…