SUSVIMO (ranibizumab)
SUSVIMO is indicated for the treatment of Neovascular Age-related Macular Degeneration; Diabetic Macular Edema; Diabetic Retinopathy.
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
- Revenue
- $11M (FY-2025)
- 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 Target & Pathway
ProTarget
A signaling protein that stimulates the formation of new blood vessels (angiogenesis). Tumors need blood supply to grow, so they secrete VEGF to create new vessels. Blocking VEGF starves tumors of oxygen and nutrients, inhibiting their growth.
Pathway Context
VEGF binds to VEGFR on blood vessel cells to stimulate new vessel formation
Receptors on blood vessel cells that respond to VEGF signals to form new blood vessels. Cancer cells exploit this pathway to ensure blood supply for tumor growth. Blocking VEGFRs prevents tumor angiogenesis and limits cancer progression.
SUSVIMO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to SUSVIMO
3 of 10FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
172 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05151731 results posted | BP43445 2021-003756-16 | Ph 2 | completed | A Study to Investigate Vamikibart (RO7200220) in Diabetic Macular Edema |
| NCT04567303 BURGUNDY | BP41670 | Ph 1, Ph 2 | active not recruiting | Study of Zifibancimig in Participants With Neovascular Age-related Macular Degeneration |
| NCT04657289 | WR42221 2020-001313-20, CIV-21-02-035827 | Ph 3 | active not recruiting | A Study of the Efficacy, Safety, and Pharmacokinetics of a 36-Week Refill Regimen for the Port Delivery System With Ranibizumab in Patients With Neovascular Age-Related Macular Degeneration (Velodrome) |
| NCT06847542 Sightspire | MR45625 2024-516924-32-00 | Ph 3 | recruiting | A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD |
| NCT06176352 POYANG | CR44829 2023-506707-25-00 | Ph 3 | active not recruiting | A Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Choroidal Neovascularization Secondary to Pathologic Myopia |
| NCT04514653 AAVIATE | RGX-314-2102 (M23-411) M23-411 | Ph 2 | active not recruiting | RGX-314 Gene Therapy Administered in the Suprachoroidal Space for Participants With Neovascular Age-Related Macular Degeneration (nAMD) |
| NCT06957080 BAROLO | EYE-RES-103 | Ph 2, Ph 3 | active not recruiting | A Study of 2 Doses of EYE103 Compared With Ranibizumab (0.5 mg) in Participants With DME |
| NCT05151744 results posted | BP43464 2021-004390-31 | Ph 2 | completed | A Study to Investigate Vamikibart (RO7200220) in Combination With Ranibizumab in Diabetic Macular Edema |
| NCT03832179 STAMP | STAMP | Ph 4 | completed | Steroid vs. Anti-vascular Endothelial Growth Factor for Diabetic Macular Edema Prior to Phacoemulsification |
| NCT06571045 BRUNELLO | EYE-RES-102 | Ph 2, Ph 3 | active not recruiting | A Study to Evaluate the Efficacy and Safety of 2 Doses of EYE103 Compared With Ranibizumab (0.5 mg) in Participants With DME |
| NCT03844074 | ONS-5010-001 | Ph 3 | completed | A Clinical Effectiveness Study Examining the Efficacy and Safety of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD) |
| NCT03834753 | ONS-5010-002 | Ph 3 | completed | A Clinical Effectiveness Study Examining the Efficacy and Safety of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD) |
| NCT06190093 | ONS-5010-008 | Ph 3 | completed | A 3-month Study to Assess the Safety and Effectiveness of ONS-5010 in Subjects with Neovascular Age-related Macular Degeneration (AMD) |
| NCT06771271 DOVETAIL | BP40899 | Ph 1 | completed | A Study to Investigate RO7200220 as Monotherapy and in Combination With Ranibizumab in Participants With Diabetic and Uveitic Macular Edema |
| NCT04740671 | HLX04-O-wAMD | Ph 3 | completed | A Phase 3 Study to Compare the Efficacy and Safety of HLX04-O with Ranibizumab in Subjects with WAMD |
| NCT02302079 VIDI | 8232-CL-3001 | Ph 2 | completed | A Study to Evaluate ASP8232 in Reducing Central Retinal Thickness in Subjects With Diabetic Macular Edema (DME) |
| NCT01944839 results posted | OPH1002 | Ph 3 | terminated | A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Lucentis® Compared to Lucentis® Monotherapy |
| NCT01940900 results posted | OPH1003 | Ph 3 | terminated | A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Lucentis® Compared to Lucentis® Monotherapy |
| NCT02387957 results posted | OPH1006 | Ph 2 | terminated | A 24 Month Phase 2a Open Label, Randomized Study of Avastin®, Lucentis®, or Eylea® (Anti-VEGF Therapy) Administered in Combination With Fovista® (Anti-PDGF BB Pegylated Aptamer) |
| NCT04075136 | IRB00058375 | Ph 4 | withdrawn | Optical Coherence Tomography Angiography (OCTA) - Directed PDT Triple Therapy |
| NCT05126966 Diagrid | MR42410 2021-003226-71 | Ph 3 | withdrawn | A Study Of The Effectiveness And Safety Of A 36-Week Refill Regimen For The Port Delivery System With Ranibizumab Vs Aflibercept Treat & Extend In Subjects With Neovascular Age-Related Macular Degeneration |
| NCT03805100 XPLORE results posted | XBR1001 | Ph 3 | completed | Comparing the Efficacy and Safety of Biosimilar Candidate Xlucane Versus Lucentis® in Patients With nAMD |
| NCT02511067 READ-4 | 0594-15-FB | Ph 2 | withdrawn | Ranibizumab for Edema of the mAcula in Diabetes: Protocol 4 With Tocilizumab: The READ-4 Study |
| NCT00606138 results posted | 06120402 | Ph 1, Ph 2 | completed | Ranibizumab for Treatment of Persistent Diabetic Neovascularization Assessed by Wide-Field Imaging |
| NCT02640664 RainbowExt results posted | CRFB002H2301E1 2014-004048-36 | Ph 3 | completed | Rainbow Extension Study |
| NCT01610557 results posted | 120134 12-EI-0134 | Ph 2 | completed | Ranibizumab and Bevacizumab for Diabetic Macular Edema |
| NCT00667472 | 20076098 | Ph 1 | withdrawn | Combined Pulsed Dye Laser and Topical Ranibizumab for Treatment of Port Wine Stain Birthmarks |
| NCT03725501 | ALS-L1023_AMD_201 | Ph 2 | completed | Evaluation of the Safety and Efficacy of ALS-L1023 Administered in Combination With Ranibizumab in Patients With Wet-AMD |
| NCT02859441 results posted | 160159 16-EI-0159 | Ph 1, Ph 2 | completed | A Phase I/II Trial for Intravitreous Treatment of Severe Ocular Von Hippel-Lindau Disease Using a Combination of the PDGF Antagonist E10030 and the VEGF Antagonist Ranibizumab |
| NCT02611778 COLUMBUS-AMD results posted | FYB201-C2015-01-P3 | Ph 3 | completed | Efficacy and Safety of the Biosimilar Ranibizumab FYB201 in Comparison to Lucentis in Patients With Neovascular Age-related Macular Degeneration |
| NCT02510794 LADDER results posted | GX28228 | Ph 2 | completed | Study of the Efficacy and Safety of the Ranibizumab Port Delivery System for Sustained Delivery of Ranibizumab in Patients With Subfoveal Neovascular Age-Related Macular Degeneration |
| NCT03345082 | OPT-302-1002 | Ph 2 | completed | A Dose Ranging Study of OPT-302 With Ranibizumab in Neovascular (Wet) AMD |
| NCT03038880 STAIRWAY results posted | CR39521 | Ph 2 | completed | Study to Evaluate Faricimab (RO6867461; RG7716) for Extended Durability in the Treatment of Neovascular Age Related Macular Degeneration |
| NCT01006538 MERLOT results posted | 09/HO206/20 2009-012509-20 | Ph 4 | completed | Macular EpiRetinal Brachytherapy Versus Lucentis® Only Treatment (MERLOT) |
| NCT02274259 | 690110 | Ph 4 | completed | Comparing Injection Frequency Between Aflibercept and Ranibizumab in Patients With CRVO With a Treat& Extend Regimen |
| NCT02484690 AVENUE results posted | BP29647 | Ph 2 | completed | A Proof-of-Concept Study of Faricimab (RO6867461) in Participants With Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD) |
| NCT01982435 REACT results posted | REACT Study | Ph 1, Ph 2 | completed | Safety and Efficacy of Ranibizumab for Diabetic Macular Edema |
| NCT03423823 ZEBRA | ZA511293 | Ph 2 | completed | Ziv-aflibercept Efficacy in Better Regulating AMD |
| NCT02699450 BOULEVARD results posted | BP30099 RG7716 | Ph 2 | completed | A Study of Faricimab (RO6867461) in Participants With Center-Involving Diabetic Macular Edema |
| NCT02358889 EMERGE results posted | IT-002 | Ph 2 | completed | Study Evaluating Intravitreal hI-con1™ in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration |
| NCT01223612 LUCIDATE | HYKP1015 | Ph 4 | completed | Lucentis (Ranibizumab) in Diabetic Macular Oedema: a Treatment Evaluation |
| NCT01306981 RaDiVit | BAIJ1006 | Ph 4 | completed | Ranibizumab in Diabetic Vitrectomy. A Prospective, Randomised Controlled Trial of Ranibizumab Pre-treatment in Diabetic Vitrectomy - a Pilot Study |
| NCT02462486 results posted | 150998-006 2014-004580-20, SEQUOIA | Ph 3 | completed | Safety and Efficacy of Abicipar Pegol in Participants With Neovascular Age-related Macular Degeneration |
| NCT02462928 CEDAR results posted | 150998-005 2014-004579-22, CEDAR | Ph 3 | completed | A Safety and Efficacy Study of Abicipar Pegol in Participants With Neovascular Age-related Macular Degeneration |
| NCT01835067 TAPAS | EudraCT Number: 2012-004078-24 | Ph 2, Ph 3 | completed | Intravitreal tPA and C3F8 for the Treatment of Submacular Haemorrhage as a Complication of Neovascular AMD |
| NCT02953938 ZIPANGU results posted | CRFB002EJP09 | Ph 4 | completed | Study to Show a Superior Benefit in Terms of Reduction of Ranibizumab Injections in Patients Receiving Ranibizumab Plus Laser Photocoagulation Combination Therapy Without Loss of Efficacy and Safety |
| NCT02665689 DORO results posted | DORO001 | Ph 4 | terminated | Influence of Diabetes Control on Treatment of Diabetic Macular Edema With Ranibizumab |
| NCT01972789 FLUID results posted | CRFB002AAU15 | Ph 4 | completed | Comparison of Treatment Regimens Using Ranibizumab: Intensive (Resolution of Intra- and Sub-retinal Fluid) vs Relaxed (Resolution of Intra-retinal Fluid and/or Sub-retinal Fluid >200µm at the Foveal Centre) |
| NCT01795209 RVOFV | B-1207-162-005 B-1207-162-005 | Ph 4 | terminated | Ranibizumab for Macular Edema Secondary to Branch Retinal Vein Occlusion in Patients With Fair Vision |
| NCT04089605 | 105136-E | Ph 4 | completed | Ranibizumab vs Dexamethasone Implant in Vitrectomized Eyes With Diabetic Macular Edema |
Showing 50 of 172 trials
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
Indications & Usage
FDA Label (PDF)SUSVIMO is indicated for the treatment of Neovascular Age-related Macular Degeneration; Diabetic Macular Edema; Diabetic Retinopathy.
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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Revenue Insights
- • FY-2025: $11M
- • Historical trend analysis
Patent Timeline
- • Patent expiration dates
- • Generic/biosimilar risk
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 10 similar drugs
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.