Genentech, a subsidiary of Roche, has initiated a voluntary recall of Susvimo, an implant authorized for wet age-related macular degeneration (AMD) that delivers a unique formulation of 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.”
Genentech said it has already notified the FDA and is currently working with the agency on the process of recalling the ocular implant and the insertion tool in the United States.
New implantations of Susvimo, including ongoing clinical trials, have reportedly been paused. However, there is no medical need to remove Susvimo from the patients who have already received it. The ranibizumab vial or refill needle are not included in the recall, therefore patients can continue receiving treatment through refills.
In addition, Genentech urges healthcare professionals to encourage their patients who have had ranibizumab injectable ocular implants to discuss the continuation of treatment. According to the company, all patients will continue to be closely monitored in accordance with the clinical trial and FDA-approved label.
In the meantime, Roche and Genentech “want to make some corrections to the manufacturing process that we hope can assure greater reliability,” Bill Anderson, CEO of Roche Pharmaceuticals added. They hope to put Susvimo back on the market as soon as possible, but it might take several months to solve the production issues. Susvimo could be reportedly back on the market within a year or so.
“We deeply regret any disruption that this may cause to people with wet AMD and the retinal community. 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 added in the statement.
In October 2021, FDA approved Susvimo (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant for the treatment of people with wet age-related macular degeneration (AMD) who have previously responded to at least two anti-vascular endothelial growth factor (VEGF) injections.
Susvimo, formerly known as Port Delivery System with Ranibizumab, is the first and only FDA-approved treatment for wet AMD that offers only two treatments per year.