Genentech, a member of the Roche Group, announced 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, AMD, following the end of a voluntary recall. The 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, the company stated in a press release. Genentech said it will work to make Susvimo available in the United States to retina specialists and their patients with wet AMD in the coming weeks. 

Susvimo provides 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. The following year, Genentech voluntarily recalled the ocular implant, insertion tool and initial fill kit in the United States following test results that showed some implants did not perform to Genentech’s standards. Genentech said that it 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, the company said.