The ranibizumab ocular implant (Susvimo) for neovascular age-related macular degeneration (nAMD) will return to the US market shortly after a voluntary hiatus of almost two years.
The Susvimo implant by Genentech is surgically inserted into the eye during a one-time outpatient procedure. It is refilled once every six months using a specifically designed needle, which introduces a customised formulation of ranibizumab directly into the device.
It was approved by the United States Food and Drug Administration in 2021. The manufacturer, Genentech voluntarily recalled the implant the following year, saying “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.
“We are pleased to reintroduce Susvimo, a unique therapeutic approach shown to provide an effective alternative to regular eye injections…”
Genentech said it expects to make the implant available to US retina specialists “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 of patients with wet AMD,” said Dr Levi Garraway, Genentech’s chief medical officer, in a company statement.
“Susvimo’s return to the retina community reflects our unwavering commitment to provide innovative retinal treatments and lays the groundwork for future advancements.”
