October 22, 2021

FDA Approves Genentech’s Susvimo, a First-of-Its-Kind Therapeutic Approach for Wet Age-Related Macular Degeneration (AMD)

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FDA Approves Genentech’s Susvimo, a First-of-Its-Kind Therapeutic Approach for Wet Age-Related Macular Degeneration (AMD)

Susvimo, previously called Port Delivery System with ranibizumab, is the first wet AMD treatment in 15 years to provide an alternative to standard-of-care eye injections needed as often as once a month. By continuously delivering medicine into the eye through a refillable implant, Susvimo may help people with wet AMD maintain their vision with as few as two treatments per year.

Genentech announced on October 21, 2021 that the U.S. Food and Drug Administration (FDA) approved Susvimo TM (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant for the treatment of people with wet (neovascular) age-related macular degeneration (AMD). The breakthrough drug delivery system is available to individuals who have previously responded to at least two anti-vascular endothelial growth factor (VEGF) injections. Susvimo, previously called Port Delivery System with ranibizumab, is the first and only FDA-approved treatment for wet AMD that offers as few as two treatments per year.

“Susvimo represents a major advancement in the treatment of retinal disease, and is an important new option for patients with wet AMD,” said Carl Regillo, M.D., Chief of Retina Service at Wills Eye Hospital in Philadelphia and an Archway study investigator. “With Susvimo, my patients now have an option that can help them maintain their vision as well as anti-VEGF injections, but on a more manageable twice-yearly treatment schedule.”

Susvimo delivers ranibizumab continuously, offering people living with wet AMD an alternative to anti-VEGF eye injections needed as often as once a month. The implant is surgically inserted into the eye during a one-time outpatient procedure and refilled every six months. If necessary, supplemental ranibizumab treatment can be given to the affected eye while the Susvimo implant is in place.

The approval is based on positive results from the Phase III Archway study primary analysis, described here in a previous post on this site.

Susvimo will be available in the United States in the coming months. For people who qualify, Genentech plans to offer patient assistance programs through Genentech Access Solutions. More information is also available at (866) 4ACCESS/(866) 422-2377 or http://www.Genentech-Access.com.

SOURCE: Genentech Press Release

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