Genentech Reintroduces Susvimo for Age-Related Macular Degeneration
Genentech had recalled the Susvimo ocular implant two years ago. The FDA has approved changes to the implant and needle.
The FDA has approved a supplement to Genentech’s biologics license application for Susvimo (ranibizumab) to treat patients with wet, or neovascular, age-related macular degeneration (AMD).
The new approval includes changes made to the ocular implant and refill needle for Susvimo, which will be available in the coming weeks, Genentech said in a news release.
The FDA had originally approved Genentech’s Susvimo for in October 2021. It is a refillable ocular implant that delivers a customized formulation of ranibizumab continuously. The implant is surgically inserted into the eye during a one-time, outpatient procedure and refilled every six months.
In October 2022, however, Genentech recalled the ocular implant, insertion tool and initial fill kit in the United States after test results that showed some implants after repeated puncturing with a needle did not perform to standards.
Genentech has since updated the Susvimo implant and refill needle, and testing confirmed that they now meet performance standards. Manufacturing process improvements were also implemented, the company said.
The price of the Susvimo implant and medicine is $16,950 the first year, and two Susvimo refills every six months in year two are priced at $16,000, according to a company spokesperson.
Genentech offers a $0 copay assistance program for the medication portion for patients with commercial insurance, with a limit of $15,000 a year.
The company also provides copay assistance for administration costs with a limit of $1,000 a year. The terms say that this assistance is for the benefit of patients. If plans adjust cost sharing programs, Genentech will impose a cap on the assistance.
Age-related macular degeneration is a condition that affects the macula, the part of the eye that provides sharp, central vision needed for activities like reading, and is a leading cause of blindness for people aged 60 and over in the United States.
Wet AMD is an advanced form of the disease that can cause rapid and severe vision loss. About 20 million people in the United States have some form of AMD, and of those, about 1.5 million have late-stage AMD, which includes wet AMD.
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