Roche to reintroduce Susvimo in US for neovascular age-related macular degeneration
Basel: Roche has 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 (US) with neovascular or ‘wet’ age-related macular degeneration (nAMD), following the end of a voluntary recall. The US Food and Drug Administration (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. Roche will work to make Susvimo available in the US to retina specialists and their patients with nAMD 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 patients with neovascular age-related macular degeneration,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Susvimo’s return to the retina community reflects our unwavering commitment to provide innovative retinal treatments, and lays the groundwork for future advancements.”
Susvimo provides continuous delivery of a customised formulation of ranibizumab via the Port Delivery Platform, while other currently approved treatments may require multiple eye injections per year.
The Susvimo implant is surgically inserted into the eye during a one-time, outpatient procedure and is refilled once every six months using a specifically designed needle, which introduces a customised formulation of ranibizumab directly into the device. Susvimo was approved by the FDA in 2021.
The following year, Roche 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 Roche’s standards. Roche 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.
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