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 to the ocular implant and refill needle for Susvimo, which will be available in the coming weeks, Genentech said in a statement. Press release.
The FDA had originally approved Genentech’s Susvimo is set to launch 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 single outpatient procedure and refilled every six months.
However, in October 2022, Genentech recalled the ocular implant, insertion tool, and initial fill kit in the United States after test results showed that some implants, after repeated punctures with a needle, did not perform to standards.
Genentech has since updated the Susvimo implant and refill needle, and testing confirmed they now meet performance standards. Improvements have also been implemented in the manufacturing process, the company said.
The price of the implant and the Susvimo drug is $16,950 for the first year, and two Susvimo refills every six months for the second year are priced at $16,000, according to a company spokesperson.
Genentech offers a $0 copay assistance program for the portion of medications for patients with commercial insurance, with a limit of $15,000 per year.
The company also offers co-pay assistance for administrative costs capped at $1,000 per year. The terms state that this assistance is for the benefit of patients. If plans adjust cost-sharing schedules, 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 such as reading, and is a leading cause of blindness in people age 60 and older 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 about 1.5 million of them have advanced AMD, which includes wet AMD.
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