TheraRadar
Data updated: Nov 8, 2026

RANIBIZUMAB · XBRANE BIOPHARMA AB

Generic · see SUSVIMO
Approved 2006-06-30

RANIBIZUMAB is FDA-approved to treat 5 conditions (same as LUCENTIS).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
20
Years on Market

Details

Status
Prescription
First Approved
2006-06-30
Routes
SOLUTION
Dosage Forms
INJECTION

Companies

XBRANE BIOPHARMA AB
Active Ingredient: RANIBIZUMAB

RANIBIZUMAB Approval History

Original
New Indication
New Form
Label Update
1 FDA actions from 2026 to 2026
Oct 2026 ORIGINAL
New Ingredient · Type 2 - New Active Ingredient
FDA Letter Label

What RANIBIZUMAB Treats

5 indications

RANIBIZUMAB is approved for 5 conditions since its original approval in 2026. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Neovascular (Wet) Age-Related Macular Degeneration (AMD)
  • Macular Edema Following Retinal Vein Occlusion (RVO)
  • Diabetic Macular Edema (DME)
  • Diabetic Retinopathy (DR)
  • Myopic Choroidal Neovascularization (mCNV)

Same approved indications as LUCENTIS (same active ingredient).

Source: FDA Label
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Clinical Trial Registry

176 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 completed 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 completed 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 MK-3000-002, 2025-520809-12-00 Ph 2, Ph 3 active not recruiting A Study of 2 Doses of Remigromig (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 MK-3000-001 Ph 2, Ph 3 active not recruiting A Study to Evaluate the Efficacy and Safety of 2 Doses of Remigromig (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 results posted 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 results posted 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 176 trials

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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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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.

RANIBIZUMAB FDA Label Details

Indications & Usage

FDA Label (PDF)

RANIBIZUMAB is FDA-approved to treat 5 conditions — same approved indications as LUCENTIS.

Looking for the branded version?

SUSVIMO

Full clinical data, patents, trials, and competitive landscape for ranibizumab.

See SUSVIMO

Data Sources

FDA Approval: BLA761187 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.