Overview
Ranibizumab is a recombinant humanized IgG1 kappa isotype monoclonal antibody fragment directed against human vascular endothelial growth factor A (VEGF-A), which is a glycoprotein implicated in the pathophysiology of age-related macular degeneration. Ranibizumab is used to treat various ocular disorders with abnormal growth of blood vessels, such as neovascular (wet) age-related macular degeneration. The development of ranibizumab first began after bevacizumab, another anti-VEGF anticancer drug, was discovered to inhibit neovascularization and used in the off-label treatment of neovascular age-related macular degeneration for intravenous injection. In order to improve drug delivery to the target organ, ranibizumab is available for intravitreal use. Ranibizumab was initially approved by the FDA in 2006 and by the European Commission (EC) in 2007. It is marketed under the brand names LUCENTIS and SUSVIMO. BYOOVIZ, a biosimilar of LUCENTIS, was approved by Health Canada in March 2022, making it the first and only biosimilar drug of ranibizumab available in Canada. In August 2022, other biosimilars CIMERLI and RAIVISIO were approved by the FDA and EC, respectively.
Indication
Ranibizumab injection for intravitreal use is indicated to treat Neovascular (wet) Age-related Macular Degeneration (AMD), macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, and myopic choroidal neovascularization. Ranibizumab injection for for intravitreal use via ocular implant is used to treat Neovascular (wet) Age-related Macular Degeneration (AMD) in patients who have responded to at least two intravitreal injections of a VEGF inhibitor.
Associated Conditions
- Diabetic Macular Edema (DME)
- Diabetic Retinopathy (DR)
- Macular Edema
- Myopic Choroidal Neovascularization
- Neovascular Age-Related Macular Degeneration (nAMD)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/05/04 | Phase 2 | Recruiting | |||
2025/04/30 | Phase 3 | Recruiting | Parc de Salut Mar | ||
2025/02/26 | Phase 3 | Not yet recruiting | |||
2025/01/13 | Phase 1 | Completed | |||
2024/08/26 | Phase 2 | Active, not recruiting | |||
2024/03/12 | Phase 3 | Recruiting | |||
2024/01/16 | Early Phase 1 | Recruiting | |||
2024/01/05 | Phase 3 | Completed | |||
2023/12/19 | Phase 3 | Active, not recruiting | |||
2023/01/27 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Coherus BioSciences Inc | 70114-441 | INTRAVITREAL | 0.5 mg in 0.05 mL | 9/22/2022 | |
| Coherus BioSciences Inc | 70114-440 | INTRAVITREAL | 0.3 mg in 0.05 mL | 9/22/2022 | |
| BIOGEN INC. | 64406-019 | INTRAVITREAL | 10 mg in 1 mL | 10/13/2023 | |
| Genentech, Inc. | 50242-078 | INTRAVITREAL | 100 mg in 1 mL | 11/17/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 8/25/2022 | ||
Authorised | 8/18/2021 | ||
Authorised | 1/5/2024 | ||
Authorised | 11/9/2022 | ||
Authorised | 9/19/2024 | ||
Authorised | 1/22/2007 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| Lucentis 10mg/ml Solution for Injection | SIN13411P | INJECTION, SOLUTION | 2.3mg | 2/15/2008 | |
| LUCENTIS SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 1.65mg/0.165ml | SIN14772P | INJECTION, SOLUTION | 1.65mg/0.165ml | 4/10/2015 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Ranibizumab Injections | 国药准字SJ20181010 | 生物制品 | 注射剂 | 11/17/2022 | |
| Ranibizumab Injections | 国药准字SJ20170004 | 生物制品 | 注射剂 | 9/16/2021 | |
| Ranibizumab Injections | 国药准字S20240034 | 生物制品 | 注射剂 | 8/13/2024 | |
| Ranibizumab Injections | 国药准字SJ20170003 | 生物制品 | 注射剂 | 9/16/2021 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| LUCENTIS SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 10MG/ML | N/A | N/A | N/A | 9/30/2024 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| RANIVIZ ranibizumab (rbe) 10 mg/mL solution for injection vial | 400126 | Medicine | A | 12/20/2023 | |
| LUCENTIS ranibizumab (rbe) 2.3 mg/0.23 mL (10mg/mL) solution for injection vial | 148325 | Medicine | A | 11/10/2008 | |
| LUCENTIS ranibizumab (rbe) 1.65 mg/0.165 mL solution for injection prefilled syringe | 212387 | Medicine | A | 11/5/2013 | |
| BYOOVIZ ranibizumab 10 mg/mL solution for injection vial | 375304 | Medicine | A | 8/24/2022 |
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