Overview
Retinal vascular diseases (RVDs) such as diabetic macular edema (DME), age-related macular degeneration (AMD), and retinal vein occlusion (RVO) are typically caused by retinal ischemia and subsequent neovascularization (NV). Vascular endothelial growth factor A (VEGF-A) is a well-known mediator of retinal NV, and many currently approved RVD therapies such as aflibercept and ranibizumab solely target VEGF-A. However, another set of factors, the Tie/Ang axis, comprising the transmembrane Tie-2 receptor and its soluble ligands Ang-1 and Ang-2, has been shown to play critical roles in mediating VEGF-A-induced NV. Faricimab is an IgG-derived bispecific antibody capable of simultaneously binding to and depleting VEGF-A and Ang-2, which has been developed to improve therapeutic efficacy, especially in patients that respond poorly to anti-VEGF-A monotherapy. Faricimab was approved by the FDA on January 28, 2022, and is currently marketed under the trademark VABYSMO by Genentech, Inc. It received subsequent approval for the same indications in Canada in May 2022. In July 2022, the EMA's Committee for Medicinal Products for Human Use (CHMP) recommended faricimab be granted marketing authorization for the treatment of neovascular age-related macular degeneration and diabetic macular edema.
Indication
Faricimab is indicated for the treatment of neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME).
Associated Conditions
- Diabetic Macular Edema (DME)
- Neovascular Age-Related Macular Degeneration (nAMD)
- Visual Impairment
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/04/03 | Phase 2 | Recruiting | Innovent Biologics Technology Limited (Shanghai R&D Center) | ||
2025/03/30 | N/A | Completed | |||
2025/03/25 | N/A | Active, not recruiting | |||
2025/03/13 | Phase 4 | Recruiting | Faculty Hospital Kralovske Vinohrady | ||
2025/02/28 | Phase 1 | Recruiting | |||
2025/01/27 | Phase 4 | Recruiting | |||
2025/01/24 | Phase 3 | Not yet recruiting | Jaeb Center for Health Research | ||
2024/12/19 | Phase 4 | Not yet recruiting | Hospital Authority, Hong Kong | ||
2024/11/29 | Phase 4 | Not yet recruiting | Association for Innovation and Biomedical Research on Light and Image | ||
2024/11/08 | N/A | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Genentech, Inc. | 50242-096 | INTRAVITREAL | 6 mg in 0.05 mL | 10/31/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 9/15/2022 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
VABYSMO SOLUTION FOR INJECTION 6MG/0.05ML | SIN16514P | INJECTION, SOLUTION | 6.00mg/0.05ml | 6/16/2022 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Faricimab Injection | 国药准字SJ20230018 | 生物制品 | 眼用制剂 | 12/13/2023 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
VABYSMO SOLUTION FOR INTRAVITREAL INJECTION 6MG/0.05ML | N/A | N/A | N/A | 12/15/2022 | |
VABYSMO SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 6MG/0.05ML | N/A | N/A | N/A | 6/23/2025 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
VABYSMO faricimab 120 mg/mL solution for injection in a pre-filled syringe | 449965 | Medicine | A | 9/30/2024 | |
VABYSMO faricimab 120 mg/mL solution for injection vial | 369935 | Medicine | A | 8/8/2022 |
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