The FDA recently approved a new therapy originally approved in 2006, Susvimo (ranibizumab) from Genentech, an ocular implant providing customized therapy for diabetic macular edema (DME). This therapy has been granted a new indication and approved an updated delivery system.
Susvimo is a refillable eye implant surgically inserted into the eye during a one-time, outpatient procedure. Susvimo continuously delivers a customized formulation of ranibizumab over time.
Susvimo is the first and only FDA-approved treatment shown to maintain vision for patients with DME. Susvimo is a vascular endothelial growth factor (VEGF) inhibitor designed to bind to and inhibit VEGF-A, a protein that has been shown to play a critical role in the formation of new blood vessels and the leakiness of the vessels.
DME is the leading cause of vision loss for patients with diabetes affecting 12% of type 1 and 28% of type 2 diabetic patients. The lifetime risk of developing DME for people with diabetes is about 10%.
Genentech originally confirmed pricing for the implant and Susvimo at $16,950 the first year, and two refills every six months in year two are priced at $16,000.
Genentech did not announce details for distribution.
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FDA approves Roche’s Susvimo as the first and only continuous delivery treatment for the leading cause of diabetes-related blindness
- Susvimo is the first and only continuous delivery treatment that offers an alternative to regular eye injections to treat diabetic macular edema (DME)
- With as few as two treatments per year, Susvimo may help people with DME maintain their vision
- Approval marks the second indication for Susvimo in addition to neovascular or ‘wet’ age-related macular degeneration (nAMD)
