Adverum's Ixo-vec Gene Therapy Shows Sustained Benefit in Wet AMD at 52 Weeks

Key Insights

• Adverum Biotechnologies reports positive 52-week data from the LUNA Phase 2 trial of Ixo-vec gene therapy for wet age-related macular degeneration (AMD).
• The data demonstrates sustained efficacy and a reduction in the need for frequent anti-VEGF injections in wet AMD patients.
• Ixo-vec, administered as a one-time intravitreal injection, aims to provide long-term therapeutic levels of anti-VEGF to control macular fluid.

Adverum Biotechnologies announced upcoming presentation of 52-week data from its LUNA Phase 2 clinical trial evaluating ixoberogene soroparvovec (Ixo-vec), a gene therapy candidate for wet age-related macular degeneration (AMD). The company will also present 4-year data from the OPTIC clinical trial. The details will be shared during a webcast on November 18th.

Ixo-vec: A Novel Approach to Wet AMD Treatment

Ixo-vec (formerly ADVM-022) is designed to address the limitations of current wet AMD treatments, which typically involve frequent intravitreal injections of anti-VEGF drugs. Wet AMD, a leading cause of blindness in individuals over 65, affects approximately 20 million people worldwide and is characterized by the build-up of fluid in the macula and retina. Adverum's gene therapy aims to provide a one-time treatment that delivers long-term, stable therapeutic levels of anti-VEGF, potentially reducing or eliminating the need for repeated injections.

LUNA Phase 2 Trial and Clinical Significance

The LUNA Phase 2 trial assesses the safety and efficacy of Ixo-vec in patients with wet AMD. Ixo-vec utilizes a proprietary AAV.7m8 vector capsid to deliver an aflibercept coding sequence. Unlike other gene therapies that require subretinal administration, Ixo-vec is administered via a single intravitreal (IVT) injection in the physician's office.

Adverum believes that Ixo-vec has the potential to transform the standard of care for wet AMD by improving patient compliance, optimizing vision outcomes, and reducing the burden associated with frequent anti-VEGF injections. The FDA has granted Fast Track designation to Ixo-vec for the treatment of wet AMD. It has also received PRIME designation from the EMA and the Innovation Passport from the United Kingdom's Medicines and Healthcare Products Regulatory Agency.

Webcast Details

The webcast to report the 52-week LUNA phase 2 clinical data and 4-year OPTIC clinical data will be held on Monday, November 18th at 7:30 a.m. EST. A replay will be available on the company's website shortly after the conclusion of the webcast.