Genentech to Re-Introduce Susvimo for Wet AMD

Genentech is re-introducing Susvimo™, its port delivery system (PDS) for the treatment of wet age-related macular degeneration (AMD). The PDS, a refillable capsule the size of a rice grain, provides continual release of ranibizumab, a protein that blocks the growth of vision-robbing, leaky blood vessels, which are the hallmarks of wet AMD.

The PDS is implanted at the surface of the eye during a one-time, outpatient surgical procedure. The PDS may be refilled as infrequently as twice a year, thereby reducing the treatment burden for patients. Other wet AMD therapies require regular injections into the vitreous, the soft gel in the middle of the eye.

Genentech plans to make Susvimo available in the US to retina specialists and their patients with wet AMD in the coming weeks. 

Susvimo was approved by the US Food & Drug Administration (FDA) in October 2021 but was voluntarily recalled by Genentech in October 2022 after reports of dislodgement of the device’s septum, a self-sealing interface through which ranibizumab is administered into the implant both prior to insertion and during refills. The FDA has approved a post-approval supplement to the Biologics License Application for Susvimo, reflecting component-level updates made to the ocular implant and refill needle.

AMD is the leading cause of blindness in people 55 and older in developed countries, affecting more than 10 million people in the US. More than one million people in the US have wet AMD. Major AMD risk factors include advancing age, smoking, and genetics.