Susvimo FDA Approval History
Last updated by Judith Stewart, BPharm on May 26, 2025.
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.
Treatment for: Macular Degeneration, Diabetic Macular Edema, Diabetic Retinopathy
Susvimo (ranibizumab) is a vascular endothelial growth factor (VEGF) inhibitor used for the treatment of neovascular (wet) age-related macular degeneration, diabetic macular edema, and diabetic retinopathy.
- Susvimo is 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.
- Diabetic Macular Edema (DME) who have previously responded to at least two intravitreal injections of a VEGF inhibitor.
- Diabetic Retinopathy (DR) who have previously responded to at least two intravitreal injections of a VEGF inhibitor. - Wet AMD, DME and DR are diseases of the retina. Wet AMD is characterized by abnormal new blood vessel growth, whereas DME and DR are primarily caused by damage to existing retinal blood vessels.
- Susvimo contains ranibizumab, a VEGF inhibitor that works by binding to VEGF-A to prevent the interaction of VEGF-A with its receptors (VEGFR1 and VEGFR2) on the surface of endothelial cells to reduce endothelial cell proliferation, vascular leakage, and new blood vessel formation. Ranibizumab is an established VEGF inhibitor first approved under the brand name Lucentis in 2006.
- Other approved ranibizumab treatments (Lucentis, Byooviz, Cimerli) may require eye injections as often as once per month. Susvimo is a refillable implant containing ranibizumab that is surgically inserted into the eye during a one-time, outpatient procedure. It is refilled approximately every six months in patients with AMD or DME, and approximately every nine months in patients with DR, to maintain therapeutic levels of medicine. Supplemental treatment with intravitreal ranibizumab injection may be administered if clinically necessary.
- The Susvimo implant and the procedures associated with inserting, filling, refilling, and removing the implant (if medically necessary) can cause serious side effects including endophthalmitis, endophthalmitis, rhegmatogenous retinal detachment, implant dislocation, septum dislodgement, vitreous hemorrhage, conjunctival retraction, conjunctival erosion, and conjunctival bleb. A decrease in visual acuity usually occurs over the first two postoperative months.
- Common adverse reactions (≥ 10%) include conjunctival hemorrhage, conjunctival hyperemia, iritis, eye pain, conjunctival disorder, cataract and vitreous hemorrhage.
Development timeline for Susvimo
Further information
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