SUSVIMO
Susvimo (ranibizumab) is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of several chronic ocular conditions. It is specifically approved for patients with neovascular (wet) age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. Use of this medication is restricted to patients who have previously demonstrated a clinical response to at least two intravitreal injections of a VEGF inhibitor.
How SUSVIMO Works
Ranibizumab works by binding to the receptor binding site of multiple active forms of VEGF-A, a protein that promotes the growth of new blood vessels and causes vascular leakage. By binding to VEGF-A, the drug prevents it from interacting with its receptors, VEGFR1 and VEGFR2, on the surface of endothelial cells. This inhibition reduces endothelial cell proliferation, decreases vascular leakage, and limits the formation of new blood vessels in the eye. These actions target the underlying biological processes that contribute to the progression of neovascular AMD and diabetic eye diseases.
Details
- Status
- Prescription
- First Approved
- 2021-10-22
- Routes
- INJECTION
- Dosage Forms
- SOLUTION
SUSVIMO Approval History
What SUSVIMO Treats
3 indicationsSUSVIMO is approved for 3 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Neovascular Age-related Macular Degeneration
- Diabetic Macular Edema
- Diabetic Retinopathy
SUSVIMO Boxed Warning
ENDOPHTHALMITIS The SUSVIMO implant has been associated with an up to 3-fold higher rate of endophthalmitis than monthly intravitreal injections of ranibizumab. Many of these events were associated with conjunctival retractions or erosions. Appropriate conjunctiva management and early detection with surgical repair of conjunctival retractions or erosions may reduce the risk of endophthalmitis. [see Contraindications (4.1) , Warnings and Precautions (5.1) ] . WARNING: ENDOPHTHALMITIS See full pre...
WARNING: ENDOPHTHALMITIS The SUSVIMO implant has been associated with an up to 3-fold higher rate of endophthalmitis than monthly intravitreal injections of ranibizumab. Many of these events were associated with conjunctival retractions or erosions. Appropriate conjunctiva management and early detection with surgical repair of conjunctival retractions or erosions may reduce the risk of endophthalmitis. [see Contraindications (4.1) , Warnings and Precautions (5.1) ] . WARNING: ENDOPHTHALMITIS See full prescribing information for complete boxed warning. The SUSVIMO implant has been associated with an up to 3-fold higher rate of endophthalmitis than monthly intravitreal injections of ranibizumab.
SUSVIMO Competitors
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SUSVIMO FDA Label Details
ProIndications & Usage
FDA Label (PDF)SUSVIMO (ranibizumab injection) 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 . 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 . 1.1 Neovascular (wet) Age-related Macular Degeneration (AMD) SUSVIMO (ranibiz...
WARNING: ENDOPHTHALMITIS The SUSVIMO implant has been associated with an up to 3-fold higher rate of endophthalmitis than monthly intravitreal injections of ranibizumab. Many of these events were associated with conjunctival retractions or erosions. Appropriate conjunctiva management and early detec...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.