Genentech to reintroduce Susvimo for wet AMD
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Genentech is set to reintroduce Susvimo for patients with wet age-related macular degeneration nearly 2 years after it voluntarily recalled the ocular implant, according to a press release.
The FDA approved a post-approval supplement to the biologics license application for Susvimo (ranibizumab injection 100 mg/mL). The implant, which continuously delivers a customized formulation of ranibizumab through the port delivery platform, is inserted during a one-time outpatient procedure and refilled every 6 months with a specially designed needle.
Susvimo was initially approved in 2021, but Genentech voluntarily recalled the implant, insertion tool and initial fill kit in the U.S. in October 2022. The company made updates to the implant and refill needle to ensure they meet performance standards, according to the release.
Genentech is working to make Susvimo available 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 3 study patients with wet AMD,” Levi Garraway, MD, PhD, chief medical officer and head of global product development at Genentech, said in the release. “Susvimo’s return to the retina community reflects our unwavering commitment to provide innovative retinal treatments and lays the groundwork for future advancements.”
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