Susvimo FDA Approval History
Last updated by Judith Stewart, BPharm on Oct 27, 2021.
FDA Approved: Yes (First approved October 25, 2021)
Brand name: Susvimo
Generic name: ranibizumab
Dosage form: Injection for Intravitreal Use via Ocular Implant
Company: Genentech, Inc.
Susvimo (ranibizumab) is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with Neovascular (wet) Age-related Macular Degeneration (AMD) who have previously responded to at least two intravitreal injections of a VEGF inhibitor.
- Ranibizumab is an established macular degeneration treatment first approved as a once-monthly intravitreal injection under the brand name Lucentis in 2006.
- Ranibizumab works by inhibiting vascular endothelial growth factor (VEGF)-A, a protein that is believed to play a critical role in the formation of new blood vessels under the retina.
- Susvimo is a refillable implant containing ranibizumab that is surgically inserted into the eye during a one-time, outpatient procedure. It is refilled about every six months to maintain therapeutic levels of medicine. Supplemental ranibizumab treatment can be given if necessary.
- The Susvimo implant and the procedures associated with inserting, filling, refilling, and (if medically necessary) removing the implant can cause other serious side effects, including endophthalmitis, conjunctival erosion, and conjunctival retraction.
- Common adverse reactions include conjunctival hemorrhage, conjunctival hyperemia, iritis, and eye pain.
Development timeline for Susvimo
|Oct 22, 2021||Approval FDA Approves Susvimo (ranibizumab) for the Treatment of Wet Age-Related Macular Degeneration (AMD)|
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