SusvimoTM is a first-of-its-kind drug delivery system for wet age-related macular degeneration (AMD), a serious late form of AMD that blurs central vision. The implantable medication device was approved by the Food and Drug Administration in the Fall of 2021. Roughly a year later, the manufacturer is voluntarily recalling SusvimoTM to fix potential leakage issues.*

About wet AMD and Susvimo

AMD affects the eye’s capacity for clear central vision. Wet AMD is another name for advanced neovascular AMD (nAMD) since it involves the uncontrolled growth of new, abnormal blood vessels under the macula, the oval-shaped central area of the retina. These vessels form from over-production of vascular endothelial growth factor (VEGF), a protein that stimulates blood vessel production. The new blood vessels can sometimes leak, causing swelling, bleeding, and /or scar tissue formation. About 20 million people globally have wet AMD, and this number is expected to rise.

Wet AMD requires frequent—usually monthly—medication injections, which is why SusvimoTM was created. The refillable device is the size of a grain of rice and is surgically placed in the eye to continuously release ranibizumab (100 mg per mL) to block VEGF production. The surgery is a one-time outpatient procedure, and the implant only needs refilling twice a year.

The FDA’s approval is based on the Archway study phase III results. Wet AMD patients receiving the SusvimoTM implant experienced the same visual gains as those receiving monthly ranibizumab injections. Over 98% of implant recipients lasted six months before needing a refill. 

Temporary recall

On October 22, 2022, Review of Optometry reported that Susvimo maker Genentech/Roche was pulling its implant from U.S. shelves to address a potential seal issue.

Genentech said it has reason to believe the device may leak medicine after repetitive puncturing with a needle during testing. “The results showed that some implants did not perform to our standards….We deeply regret any disruption that this may cause to people with wet AMD and the retinal community,” said CEO Bill Anderson in a company statement. “[B]ecause it didn’t meet our performance standards, and [because] we want to make sure that we have high reliability, we decided to voluntarily stop distribution of the port delivery system.”

Patients can continue receiving refills as usual with no explanation needed, the company said, though no new implants will be done until the issues are resolved and the device returns to market—estimated at no longer than about a year. Healthcare providers are being advised to discuss continued treatment with patients. Meanwhile, the company is providing support and guidance to help patients maintain positive results and said it will be monitoring patients closely.

*Review of Optometry Staff. (2022, October 20). Susvimo AMD Implant Recalled Due to Potential for Leakage. Review of Optometry. https://www.reviewofoptometry.com/article/susvimo-amd-implant-recalled-due-to-potential-for-leakage

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