The company noted that testing of a commercial supply of the implants, which included exposing them to multiple punctures with a needle, found they did not meet their standards. The company has notified the FDA, and is working with the agency on the recall process.
Genentech is voluntarily recalling the ranibizumab injection (Susvimo) ocular implant and insertion tool for the treatment of people with wet age-related macular degeneration (wet AMD) in the United States.
According a company spokesperson, Genentech is currently in the process of recalling the Susvimo ocular implant and insertion tool in the U.S. It has notified the FDA, and is now working with the agency on the recall process.
Formerly called the Port Delivery System, Genentech received FDA approval on Oct. 22, 2021,
the first wet, or neovascular, AMD treatment in 15 years to provide an alternative to standard-of-care eye injections needed as often as once a month.
Susvimo delivers ranibizumab continuously, offering patients living with wet AMD an alternative to anti-VEGF eye injections needed as often as once a month. The implant is surgically inserted into the eye during a one-time, outpatient procedure and refilled every 6 months. If necessary, supplemental ranibizumab treatment can be given to the affected eye while the Susvimo implant is in place.
In a statement, the company said that new implantations, including in ongoing global clinical trials, have been paused. Outside of the United States and Canada, the device is called Port Delivery System with ranibizumab.
“The voluntary recall is based on recent testing of our commercial supply in which Susvimo implants were exposed to repeated puncturing with a needle,” the company said in a statement. “The results showed that some implants did not perform to our standards.”
According to the company, for patients who have already received the ranibizumab injection ocular implant, there is no medical reason to remove it, nor is this 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,” the company added in the statement.
Moreover, the company noted that its top priority is ensuring the well-being of patients and the highest quality of its products.
The company also said it has notified the FDA and is working with the agency on the recall process.
“We have also taken immediate steps to inform other health authorities, healthcare professionals, clinical trial investigators, and patient organizations, and will continue to provide support and guidance to help ensure the best outcomes for patients,” the company said in the statement.
According to the statement, healthcare providers are encouraged to discuss the continuation of treatment with their patients treated with ranibizumab injection ocular implant. The company said that close 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,” the company concluded in the statement. “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.”