Roche Recalls Eye Implant for Manufacturing and Leakage Issues

Roche has recalled the Susvimo eye drug delivery implant after it was tested by repeated puncturing with a refill needle and did not perform to company standards.

The implant is used to treat adults with wet age‑related macular degeneration (AMD) who have responded to at least two injections of a vascular endothelial growth factor (VEGF) inhibitor. The implant releases a formulation of ranibizumab into the eye, providing treatment for six months.

The manufacturing issue involves the seal on the port delivery device that prevents the medicine from leaking out once it has been injected.

Wet AMD usually requires treatment with eye injections up to once a month. Susvimo would potentially reduce that to twice a year. The implant was approved by the FDA in October 2021.

The company is also pausing new implantations of Susvimo in clinical trials. Patients who already have the implant do not need to have it removed and can continue to receive treatment since the recall does not include the ranibizumab or refill needle, Roche said.