Genentech to Reintroduce Susvimo Ocular Implant for Wet AMD
Following the end of a voluntary recall, Genentech said it is reintroducing Susvimo (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant for the treatment of wet age-related macular degeneration (AMD).
The decision comes after the FDA 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 ssid it will work to make Susvimo available in the US to retina specialists and their patients with 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, Genentech’s chief medical officer and head of Global Product Development, said in a company news release. “Susvimo’s return to the retina community reflects our unwavering commitment to provide innovative retinal treatments, and lays the groundwork for future advancements.”
Susvimo is designed to provide continuous delivery of a customized formulation of ranibizumab via the Port Delivery Platform. The Susvimo implant is surgically inserted into the eye during a one-time, outpatient procedure and is refilled once every 6 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. In October 2022, Genentech voluntarily recalled the ocular implant, insertion tool and initial fill kit in the US following test results that showed some implants did not perform to standards. During a call with investors at the time, Roche CEO Bill Anderson provided more details of the manufacturing issue.
“We noticed in our laboratory testing—reliability testing—that in certain cases, the septum, which is the seal on the port delivery device that prevents the medicine from leaking out once its been injected in, that seal could fail after repeated dosing … Because it didn’t meet our performance standards and we want to make sure that we have high reliability, we decided to voluntarily stop distribution of the Port Delivery System.”
Genentech now says it has since updated the implant and refill needle, and testing confirmed that they now meet these performance standards. Manufacturing process improvements were also implemented.
For more information, visit Susvimo.com. To view EyewireTV's coverage of the reintroduction of Susvimo, click here.