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

– Both dose levels (2E11 & 6E10) demonstrate potential best-in-class clinical activity in hard-to-treat patients including treatment burden reduction and maintenance of both visual acuity and anatomic endpoints –

– Preliminary safety data support a favorable benefit-risk profile at both dose levels –

– Ozurdex + difluprednate identified as potential “go-forward” prophylaxis –

– The vast majority of patients on the “go-forward” regimen had no inflammation and >90% of patients have no or minimal inflammation (0 or 0.5+ AC cells) –

– Preliminary efficacy and safety data trending similar to or better than the OPTIC study, in which patients continue to see on-going clinical benefit through at least 3 years –

– Webcast to be held today Thursday, February 8 at 8:00 a.m. EST –

REDWOOD CITY, Calif., Feb. 08, 2024 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage company pioneering the use of gene therapy as a new standard of care for highly prevalent ocular diseases, today 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. 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.

“Wet AMD is a leading cause of blindness in people over the age of 65, requiring life-long anti-VEGF injections. Our goal with Ixo-vec is to provide patients virtually injection-free management of their wet AMD lasting years and potentially for life,” stated Laurent Fischer, M.D., president and chief executive officer of Adverum Biotechnologies. “We are pleased with the emerging treatment profile of Ixo-vec, showing potential for best-in-class efficacy and over 90% of subjects having no or minimal inflammation with our go-forward local prophylactic regimen. Underscoring the potential best-in-class profile of Ixo-vec, these early activity results were seen in hard-to-treat patients, who received over 9 annualized injections in the year prior to receiving Ixo-vec. Going into LUNA, we looked to replicate the robust clinical activity seen in OPTIC, in which patients continued to see clinical benefit through 3 years, with measured stable aflibercept through 4.5 years. We are proud to build upon our pioneering efforts with the most mature dataset and longest follow-up of all wet AMD intravitreal gene therapies currently in development.”