The U.S. Food and Drug Administration (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. Genentech will work to make Susvimo available in the U.S. to retina specialists and their patients with wet AMD 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 provides continuous delivery of a customized formulation of ranibizumab via the Port Delivery Platform, while other currently approved treatments may require multiple eye injections per year.
The Susvimo implant is surgically inserted into the eye during a one-time, outpatient procedure and is refilled once every six months using a specifically designed needle, which introduces a customized formulation of ranibizumab directly into the device. Susvimo was approved by the FDA in 2021.
The following year, Genentech voluntarily recalled the ocular implant, insertion tool and initial fill kit in the U.S. following test results that showed some implants did not perform to Genentech’s standards. Genentech has since updated the Susvimo implant and refill needle, and testing confirmed that they now meet these performance standards. Manufacturing process improvements were also implemented.
Genentech is committed to helping people access the medicines they are prescribed and offers comprehensive services for people prescribed Susvimo to help minimize barriers to access and reimbursement. Patients can call 833-EYE-GENE for more information. For people who qualify, Genentech offers patient assistance programs through Genentech Access Solutions.
About Genentech in Ophthalmology:
Genentech is researching and developing new treatments for people living with a range of eye diseases that cause significant visual impairment and blindness, including wet age-related macular degeneration (AMD), diabetic macular edema (DME), diabetic retinopathy (DR), geographic atrophy (GA) and other retinal diseases, including rare and inherited conditions.
About Genentech:
Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company,
For more information please visit http://www.gene.com.
