Genentech announces reintroduction of Susvimo for Wet AMD treatment in US

Genentech, a key member of the Roche Group, has officially announced the reintroduction of Susvimo (ranibizumab injection) 100 mg/mL, a cutting-edge treatment for wet, or neovascular, age-related macular degeneration (AMD) in the United States. This comes after a voluntary recall and subsequent approval by the U.S. Food and Drug Administration (FDA) of a post-approval supplement to the Biologics License Application for Susvimo. The update reflects significant component-level enhancements to the ocular implant and the refill needle. Genentech aims to make Susvimo available to retina specialists and their patients in the coming weeks.

The reintroduction follows a thorough review and upgrade of the Susvimo implant system components. After identifying performance discrepancies in some implants, Genentech voluntarily recalled the product in the U.S. and has since made substantial improvements to both the implant and refill needle. The FDA has now approved these updates, ensuring that the product meets stringent safety and efficacy standards.

Susvimo offers a unique therapeutic approach by providing continuous delivery of a customized formulation of ranibizumab via the Port Delivery Platform. This system stands out because, unlike other treatments that might require multiple eye injections per year, Susvimo only needs to be refilled twice annually. This method significantly reduces the treatment burden on patients and potentially improves adherence to therapy.

The Susvimo implant is surgically inserted into the eye during a one-time, outpatient procedure. It is designed for long-term use and requires refilling every six months using a specially designed needle, which administers a precise formulation of ranibizumab directly into the device. This method ensures a continuous and steady delivery of the medication, which is critical for treating this progressive eye condition.

Approved initially by the FDA in 2021, Susvimo, previously known as the Port Delivery System with ranibizumab, represents a significant advancement in the treatment of AMD. It targets VEGF-A, a protein known to play a critical role in the formation of new blood vessels and the leakiness of the vessels, which are prominent factors in the progression of wet AMD. This reintroduction marks an important milestone in Genentech’s commitment to innovative retinal treatments and underscores their ongoing efforts to support patients with serious retinal diseases.