Genentech Voluntarily Recalls Susvimo Ocular Implant for Wet AMD
Roche and Genentech announced a voluntarily recall of the Susvimo (ranibizumab injection) ocular implant for wet AMD, citing a manufacturing problem with the device. In addition, the companies announced that new implantations, including in ongoing global clinical trials, have been paused.
The voluntary recall, which comes a year after FDA approval, is based on recent testing of its commercial supply in which Susvimo implants were exposed to repeated puncturing with a needle. The results showed that some implants did not perform to the company’s standards,” according to a Genentech statement.
In a call with investors, Roche Pharmaceuticals CEO Bill Anderson provided more details of the manufacturing issue.
“We noticed in our laboratory testing—reliability testing—that in certain cases, the septum, which is the seal on the port delivery device that prevents the medicine from leaking out once its been injected in, that seal could fail after repeated dosing … Because it didn’t meet our performance standards and we want to make sure that we have high reliability, we decided to voluntarily stop distribution of the Port Delivery System.”
Genentech, a member of the Roche Group, is responsible for the distribution of Susvimo in the US. The company said it notified the FDA and is working with the agency on the recall process. Genentech added that it took immediate steps to inform other health authorities, health care professionals, clinical trial investigators, and patient organizations. For patients already implanted with Susvimo, there is no medical need to remove it.
“This is not a recall of the ranibizumab vial or refill needle, and eligible patients can continue receiving treatment via refills. We deeply regret any disruption that this may cause to people with wet AMD and the retinal community,” according to Genentech.
During the conference call, Mr. Anderson said the company has been working on correcting the manufacturing issue, making modifications, and hopes to be able to resolve the issue “in a matter of months” with a device back in the market “within a year or so.”
Genentech encouraged health care providers to discuss the continuation of treatment with their patients treated with Susvimo. Monitoring of all patients will continue in line with the FDA-approved label and clinical trial protocols.
“We believe in the potential of this innovative drug delivery system to meet the needs of people living with retinal diseases. Genentech is committed to delivering the highest quality products and is working to find a solution and path forward so that people with wet AMD can continue benefiting from Susvimo,” according to the statement.
In October 2021, Genentech received FDA approval for Susvimo. Previously called Port Delivery System with ranibizumab, Susvimo was the first and only FDA-approved treatment for wet AMD that offers as few as two treatments per year.