Genentech Voluntarily Recalls SUSVIMO (ranibizumab)

This month, Genentech announced a voluntary recall of the ranibizumab injection (SUSVIMO) ocular implant and associated insertion tool.  SUSVIMO, which provides continuous administration of the anti-VEGF (vascular endothelial growth factor A) monoclonal antibody fragment ranibizumab, is approved by the FDA for treatment of wet age-related macular degeneration.  According to Genentech, the issue was identified as a result of septum dislodgement cases observed during phase III clinical trials.  Per the Genentech Head of U.S. Medical Affairs Jamie Freedman, MD, PhD, “we identified a need for additional testing of the commercial implant supply. This additional testing . . . involved repeatedly puncturing SUSVIMO implants with a needle, to evaluate performance…over the long-term via multiple refills.  The results showed that some implants did not perform to our standards. Hence, a pause in all new implantations is required.”