Adverum announces 3-year efficacy, safety results from OPTIC extension study

Adverum Biotechnologies announced updated data from the OPTIC extension study of patients with wet AMD during the Retina Subspecialty Day at the American Academy of Ophthalmology 2023 Annual Meeting in San Francisco, California. A summary of previously announced aflibercept protein levels from the LUNA study was also presented. An oral presentation titled “ADVM-022 Intravitreal Gene Therapy for Neovascular AMD: Preliminary Data from the Phase 2 LUNA Trial and 3-Year Results From the Phase 1 OPTIC-Extension Trial” was presented at the AAO 2023 Annual Meeting. Patients in the OPTIC extension trial continue to experience long-term benefit from Ixo-vec through 3 years of follow-up, including maintenance of vision, durability of anatomical improvements and sustained reduction in anti-VEGF treatment burden. Patients at the 2E11 dose had an 84% reduction in annualized anti-VEGF injections, with 53% of the participants at the 2E11 dose receiving no supplemental injections through three years. Aflibercept protein levels have been sustained through follow-up, which is up to 4.5 years post-treatment. BCVA was maintained and CST was improved through 3 years. Ixo-vec was generally well tolerated with dose-dependent inflammation that was responsive to topical steroids. Aflibercept protein data suggest Ixo-vec at the 2E11 and 6E10 doses deliver similar levels of aflibercept that are both within the therapeutically active range based on OPTIC and non-human primate data. The LUNA trial population has comparable injection frequency and other baseline characteristics, with slightly better visual acuity and fluid control, compared to the study population of OPTIC. In particular, the mean annualized anti-VEGF injection rate in the 12 months prior to Ixo-vec treatment in LUNA is 9.9 injections, indicating that these subjects require frequent injections, administered approximately every six weeks.