Susvimo, previously called Port Delivery System with ranibizumab (Lucentis), was FDA-approved on October 21, 2021, for intravitreal use via ocular implant for the treatment of people with wet (neovascular) age-related macular degeneration (AMD). Now, one year later, Genentech has announced that it is voluntarily recalling the implant and the insertion tool in the U.S.
As reported here earlier, Susvimo is the first wet AMD treatment in 15 years to provide an alternative to standard-of-care eye injections needed as often as once a month. By continuously delivering medicine into the eye through a refillable implant, Susvimo is expected to help people with wet AMD maintain their vision with as few as two treatments per year.
According to a statement released by Genentech, “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 results showed that some implants did not perform to our standards.” The company also assures that there is no medical reason to remove implants already in place, and treatment via refills may continue safely for those patients.
Genentech is to be commended for its commitment to maintaining the highest quality product and for taking action to find a solution and a path forward so that people with wet AMD can continue benefiting from Susvimo.