Genentech (Roche) has announced a voluntarily recall of the “Susvimo” (ranibizumab injection) ocular implant for wet AMD, citing a manufacturing problem with the device. The voluntary recall is based on recent testing of its commercial supply in which Susvimo implants were exposed to repeated puncturing with a needle. The results indicated that some implants did not perform to the company’s standards, according to a Genentech statement. Roche Pharmaceuticals’ (SIX: RO, ROG; OTCQX: RHHBY) CEO Bill Anderson stated, “[w]e 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.” In addition, the companies announced that new implantations, including in ongoing global clinical trials, have been paused.
Previously, the US FDA has approved a 100 mg/mL ocular implant (Port Delivery System) for the treatment of nAMD in October 2021. The ocular implant, tested in the “Archway” trial (NCT03677934), used a randomised, multicentre, open-label phase III study with a refillable anti-VEGF treatment allowing fixed intervals for every six-months. In follow-up to the Archway study, the implant may be refilled every six months at fixed intervals, compared to monthly intravitreal injections of ranibizumab (0.5 mg) with 415 participants with nAMD. The trial was an RCT, multicenter, open-label Phase III study evaluating the efficacy and safety of the Port Delivery System with ranibizumab (PDS). The PDS is an implantable “reservoir-based, slow-release platform which sits in the sclera and delivers ranibizumab in a concentrated solution at different doses in the setting of nAMD”.
According to Genentech, “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,” Genetech is responsible for the distribution of Susvimo in the US and it has notified the FDA to be working on the recall process. In addition, the company 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. Monitoring of all patients will continue in line with the FDA-approved label and clinical trial protocols. In concluding in their statement, Genetech said that, “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”.