Roche (SWX: RO), the Swiss pharmaceutical giant, has announced the conclusion of the voluntary recall of its Susvimo (ranibizumab) 100mg/mL intravitreal ocular implant in the U.S. market. The implant, indicated for the treatment of neovascular (wet) age-related macular degeneration (nAMD), has received approval from the U.S. Food and Drug Administration for a supplement to the product’s existing Biologics License Application (BLA). This supplement reflects updates made by Roche to the Susvimo implant and refill needle components, as well as the manufacturing process.
The Susvimo system is a “port” implant designed for surgical insertion into the eye, facilitating the continuous delivery of medication to a localized area. Specifically, the VEGF inhibitor ranibizumab is administered and can be replenished every six months. Initially approved by the FDA in 2021, the product was voluntarily withdrawn by Roche within a year of its launch due to substandard quality findings in some implant components. Roche has now resolved these issues and plans to relaunch the product in the coming weeks.- Flcube.com
