Genentech, a subsidiary of Roche, has re-introduced its Susvimo (ranibizumab) 100mg/mL for intravitreal use through an ocular implant in the US, after its voluntary recall in 2021.
The US Food and Drug Administration (FDA) has approved a post-approval supplement to the Biologics License Application (BLA) for Susvimo with updated ocular implant and refill needle.
Susvimo is indicated for the treatment of US people with wet, or neovascular, age-related macular degeneration (AMD).
It provides continuous delivery of ranibizumab through the Port Delivery Platform, while other currently approved treatments may require multiple eye injections per year.
Genentech will start commercialising Susvimo in the US, to retina specialists and their patients with wet AMD in the coming weeks.
Genentech chief medical officer and global product development head Levi Garraway said: “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.
“Susvimo’s return to the retina community reflects our unwavering commitment to provide innovative retinal treatments and lays the groundwork for future advancements.”
Susvimo implant is designed for surgical insertion into the eye during a one-time procedure and is refilled once every six months using a specifically designed needle.
The needle will deliver a customised formulation of ranibizumab directly into the device.
Ranibizumab is a vascular endothelial growth factor (VEGF) inhibitor that binds to and inhibits VEGF-A, which plays a key role in the formation of new blood vessels and their leakiness.
Genentech secured FDA approval for Susvimo in 2021, and voluntarily recalled the ocular implant, insertion tool and initial fill kit in the US, the following year.
The recall was based on test results that showed some implants did not perform according to the company’s standards.
Genentech implemented improvements in the manufacturing process, and testing confirmed that the implants meet the performance standards.
