Ranibizumab
- Generic Name
- Ranibizumab
- Brand Names
- Byooviz, Cimerli, Lucentis, Susvimo, Ranivisio, Rimmyrah, Ximluci, Epruvy (previously Ranibizumab Midas)
- Drug Type
- Biotech
- CAS Number
- 347396-82-1
- Unique Ingredient Identifier
- ZL1R02VT79
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.
Background
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
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2009/05/13 | Phase 2 | Completed | |||
2009/05/12 | Phase 2 | Completed | Steven R. Sanislo | ||
2009/05/04 | Not Applicable | Completed | |||
2009/05/01 | Phase 3 | Completed | |||
2009/04/22 | Phase 2 | UNKNOWN | The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery | ||
2009/03/06 | Phase 2 | Terminated | |||
2009/02/19 | Phase 2 | Withdrawn | |||
2009/02/11 | Phase 2 | Completed | |||
2009/02/05 | Phase 1 | Completed | Southeast Retina Center, Georgia | ||
2009/01/28 | Phase 2 | Completed |
FDA Approved Products
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HSA Approved Products
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NMPA Approved Products
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PPB Approved Products
Product Name | Registration Code | Company | Category | Sale Type | Reg. Date |
|---|---|---|---|---|---|
HK-68384 | Part 1, Schedule 1 & Schedule 3 Poison | POM | 2024/09/30 |
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