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Port delivery system with ranibizumab (Susvimo) recall- What does it mean to the retina specialists
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Port delivery system with ranibizumab (Susvimo) recall- What does it mean to the retina specialists
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Journal Article
Port delivery system with ranibizumab (Susvimo) recall- What does it mean to the retina specialists
2023
Overview
Port delivery system (PDS) with ranibizumab (Susvimo, Genentech, USA) was approved by the U.S. Food and Drug Administration (FDA) on 22nd October 2021 for the management of neovascular age-related macular degeneration (n-AMD) in eyes with at least two prior anti-vascular endothelial growth factor (VEGF) injections [1, 2]. [...]it did not include the Susvimo (ranibizumab injection) 100 mg/ml drug vial for a refill-exchange solution and refill needles in order to allow for continued refill-exchange procedures in eligible patients in clinical trials as well as in the commercial setting who already have an implant. The control arm in phase 2 and 3 studies was monthly ranibizumab and data from both studies show that PDS significantly reduces the treatment burden compared to monthly injections. [...]PDS can be clinically beneficial by decreasing treatment burden for patients with nAMD, especially the high need patients requiring frequent injections.
