Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), has announced the reintroduction of Susvimo® (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant in the United States (U.S.) for the treatment of individuals with wet, or neovascular, age-related macular degeneration (AMD). This follows the conclusion of a voluntary recall. The U.S. Food and Drug Administration (FDA) has approved a post-approval supplement reflecting updates to the ocular implant and refill needle components. Genentech aims to make Susvimo available to retina specialists and their patients with wet AMD in the U.S. in the coming weeks.
“We are pleased to reintroduce Susvimo, a unique therapeutic approach shown to provide an effective alternative to regular eye injections by preserving vision with two refills per year in Phase III study patients with wet AMD,” said Levi Garraway, M.D., Ph.D., Genentech’s chief medical officer and head of Global Product Development. “Susvimo’s return to the retina community reflects our unwavering commitment to provide innovative retinal treatments, and lays the groundwork for future advancements.”
Susvimo delivers a customized formulation of ranibizumab continuously via the Port Delivery Platform, offering a streamlined treatment option compared to multiple annual eye injections required by other treatments currently available.
The implantation of Susvimo involves a one-time, outpatient procedure, with refills administered every six months using a specially designed needle that introduces ranibizumab directly into the device. FDA approval for Susvimo was granted in 2021. Following a voluntary recall in the subsequent year due to performance issues identified during testing, Genentech has since enhanced the design of the Susvimo implant and refill needle, ensuring they now meet rigorous performance standards. Additionally, improvements have been made to the manufacturing process.
Genentech remains dedicated to supporting patient access to Susvimo, providing comprehensive services to help mitigate access and reimbursement challenges.
About Wet Age-Related Macular Degeneration (AMD):
Age-related macular degeneration (AMD) affects the macula, crucial for sharp central vision needed in activities like reading, and is a leading cause of blindness among individuals aged 60 and older in the U.S. Wet AMD, an advanced form of the disease, leads to rapid and severe vision loss due to abnormal blood vessel growth (choroidal neovascularization) in the macula, causing leakage and scarring that damages the central retina.
About Susvimo® (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant:
Susvimo is a refillable implant surgically placed into the eye during a one-time, outpatient procedure. It continuously administers a customized formulation of ranibizumab over time. Susvimo is specifically indicated for intravitreal use via its implant only. Ranibizumab, a vascular endothelial growth factor (VEGF) inhibitor, targets VEGF-A, a protein crucial in new blood vessel formation and vessel permeability. Susvimo was formerly known as the Port Delivery System with ranibizumab in the U.S.
The formulation delivered by Susvimo differs from ranibizumab intravitreal injection, marketed as Lucentis® (ranibizumab injection), approved for treating wet AMD and other retinal diseases since 2006 by the FDA.
