Feb 1, 2022

Genentech-Roche Receives FDA Approval for Vabysmo for Treatment of Wet AMD and DME

Eye On the Cure Research News

This new treatment can reduce the frequency of injections into the eye

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Genentech, a global biotechnology company and member of the Roche Group, has received approval from the US Food & Drug Administration (FDA) for VabysmoTM (faricimab-svoa) for the treatment of wet age-related macular degeneration (AMD) and diabetic macular edema (DME). The treatment is injected into the patient’s vitreous, the soft gel in the middle of the eye, as infrequently as every 16 weeks at an eye doctor’s office.

Vabysmo can reduce the treatment burden for wet AMD and DME patients. Existing FDA-approved treatments for wet AMD and DME often require injections on a more frequent basis — for example, every 4, 8, or 12 weeks. Dosing regimens for Vabysmo and other treatments are based on the patient’s individual need.

Both wet AMD and DME are characterized by the growth of harmful, leaky blood vessels underneath the retina that can lead to loss of both retinal cells and central vision.

Vabysmo inhibits two distinct disease pathways: vascular endothelial growth factor-A (VEGF-A) and angiopoietin-2 (Ang-2). Both are proteins in the retina that promote the growth of the unhealthy blood vessels.

In January 2021, Genentech reported that Vabysmo performed as well as aflibercept (Eylea®, an FDA-approved treatment) when injected every 16 weeks in four Phase 3 clinical trials.

Wet AMD affects about 1 million people in the US. DME affects about 750,000 in the US.

For more information on AMD, visit the AMD section of the Foundation’s website.

Contact your doctor if you have questions about which therapies are best for you.