Genentech to Reintroduce Susvimo for People With Wet AMD

The FDA has approved updates to Susvimo, which will be available to U.S. retina specialists and patients with wet AMD in the coming weeks.

Genentech announced today the reintroduction of Susvimo® (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant for the treatment of people in the United States with wet, or neovascular, age-related macular degeneration (AMD), following the end of a voluntary recall. The U.S. Food and Drug Administration (FDA) has approved a post-approval supplement to the Biologics License Application for Susvimo, reflecting component-level updates made to the ocular implant and refill needle. Genentech will work to make Susvimo available in the U.S. to retina specialists and their patients with wet AMD in the coming weeks.

“We are pleased to reintroduce Susvimo, a unique therapeutic approach shown to provide an effective alternative to regular eye injections by preserving vision with two refills per year in Phase III study patients with wet AMD,” said Levi Garraway, M.D., Ph.D., Genentech’s chief medical officer and head of Global Product Development. “Susvimo’s return to the retina community reflects our unwavering commitment to provide innovative retinal treatments, and lays the groundwork for future advancements.”

Susvimo provides continuous delivery of a customized formulation of ranibizumab via the Port Delivery Platform, while other currently approved treatments may require multiple eye injections per year.

The Susvimo implant is surgically inserted into the eye during a one-time, outpatient procedure and is refilled once every six months using a specifically designed needle, which introduces a customized formulation of ranibizumab directly into the device. Susvimo was approved by the FDA in 2021. The following year, Genentech voluntarily recalled the ocular implant, insertion tool and initial fill kit in the U.S. following test results that showed some implants did not perform to Genentech’s standards. Genentech has since updated the Susvimo implant and refill needle, and testing confirmed that they now meet these performance standards. Manufacturing process improvements were also implemented.

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