Faricimab

Faricimab is a humanized bispecific antibody that acts through inhibition of two pathways by binding to VEGF-A and Ang-2. By inhibiting VEGF-A, faricimab suppresses endothelial cell proliferation, neovascularization and vascular permeability.

• VABYSMO is a vascular endothelial growth factor (VEGF) and angiopoietin 2 (Ang-2) inhibitor indicated for the treatment of patients with: VABYSMO is a vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2) inhibitor indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (nAMD) ( 1.1 ) Diabetic Macular Edema (DME) ( 1.2 ) Macular Edema Following Retinal Vein Occlusion (RVO) ( 1.3 ) 1.1 Neovascular (wet) Age-Related Macular Degeneration (nAMD) 1.2 Diabetic Macular Edema (DME) 1.3 Macular Edema Following Retinal Vein Occlusion (RVO)ICD-10: R60.9

• Ocular or periocular infection ( 4.1 ) Active intraocular inflammation ( 4.2 ) Hypersensitivity ( 4.3 ) 4.1 Ocular or Periocular Infections VABYSMO is contraindicated in patients with ocular or periocular infections. 4.2 Active Intraocular Inflammation VABYSMO is contraindicated in patients with active intraocular inflammation.contraindicated

For intravitreal injection. ( 2.1 ) Neovascular (Wet) Age-Related Macular Degeneration (nAMD) The recommended dose for VABYSMO is 6 mg (0.05 mL of 120 mg/mL solution) administered by intravitreal injection every 4 weeks (approximately every 28 ± 7 days, monthly) for the first 4 doses, followed by optical coherence tomography and visual acuity evaluations 8 and 12 weeks later to inform whether to give a 6 mg dose via intravitreal injection on one of the following three regimens: 1) Weeks 28 and 44; 2) Weeks 24, 36 and 48; or 3) Weeks 20, 28, 36 and 44. Although additional efficacy was not demonstrated in most patients when VABYSMO was dosed every 4 weeks compared to every 8 weeks, some patients may need every 4 week (monthly) dosing after the first 4 doses. Patients should be assessed regularly. ( 2.2 ) Diabetic Macular Edema (DME) VABYSMO is recommended to be dosed by following one of these two dose regimens: 1) 6 mg (0.05 mL of 120 mg/mL solution) administered by intravitreal injection every 4 weeks (approximately every 28 days ± 7 days, monthly) for at least 4 doses.

Endophthalmitis and retinal detachments may occur following intravitreal injections. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay, to permit prompt and appropriate management. ( 5.1 ) Increases in intraocular pressure have been seen within 60 minutes of an intravitreal injection. ( 5.2 ) There is a potential risk of arterial thromboembolic events (ATEs) associated with VEGF inhibition. ( 5.3 ) 5.1 Endophthalmitis and Retinal Detachments Intravitreal injections, including Vabysmo, have been associated with endophthalmitis and retinal detachments [see Adverse Reactions (6.1) ] . Proper aseptic injection techniques must always be used when administering VABYSMO. Patients should be instructed to report any signs or symptoms suggestive of endophthalmitis or retinal detachment without delay, to permit prompt and appropriate management [see Dosage and Administration (2.6) and Patient Counseling Information (17) ]. 5.2 Increase in Intraocular Pressure Transient increases in intraocular pressure (IOP) have been seen within 60 minutes of intravitreal injection, including with VABYSMO [see Adverse Reactions (6.1) ]. IOP and the perfusion of the optic nerve head should be monitored and managed appropriately [see Dosage and Administration (2.6) ]. 5.3 Thromboembolic Events Although there was a low rate of arterial thromboembolic events (ATEs) observed in the VABYSMO clinical trials, there is a potential risk of ATEs following intravitreal use of VEGF inhibitors.

The following potentially serious adverse reactions are described elsewhere in the labeling: Hypersensitivity [see Contraindications (4) ] Endophthalmitis and retinal detachments [see Warnings and Precautions (5.1) ] Increase in intraocular pressure [see Warnings and Precautions (5.2) ] Thromboembolic events [see Warnings and Precautions (5.3) ] Retinal Vasculitis and/or Retinal Vascular Occlusion [see Warnings and Precautions (5.4) ] The most common adverse reactions (≥ 5%) reported in patients receiving VABYSMO were cataract (15%) and conjunctival hemorrhage (8%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Genentech at 1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in other clinical trials of the same or another drug and may not reflect the rates observed in practice. The data described below reflect exposure to VABYSMO in 2,567 patients, which constituted the safety population in six Phase 3 studies [see Clinical Studies (14.1 , 14.2 , 14.3) ] .

8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies of VABYSMO administration in pregnant women. Administration of VABYSMO to pregnant monkeys throughout the period of organogenesis resulted in an increased incidence of abortions at intravenous (IV) doses 158 times the human exposure (based on C max ) of the maximum recommended human dose [see Animal Data ] . Based on the mechanism of action of VEGF and Ang-2 inhibitors, there is a potential risk to female reproductive capacity, and to embryo-fetal development. VABYSMO should not be used during pregnancy unless the potential benefit to the patient outweighs the potential risk to the fetus. All pregnancies have a background risk of birth defect, loss, and other adverse outcomes. The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects is 2%-4% and of miscarriage is 15%-20% of clinically recognized pregnancies. Data Animal Data An embryo fetal developmental toxicity study was performed on pregnant cynomolgus monkeys. Pregnant animals received 5 weekly IV injections of VABYSMO starting on day 20 of gestation at 1 or 3 mg/kg. A non-dose dependent increase in pregnancy loss (abortions) was observed at both doses evaluated.

Metabolism

Absorption/Distribution Maximum faricimab plasma concentrations (Cmax) are estimated to occur approximately 2 days post-dose. Mean (±SD) free faricimab (unbound to VEGF-A and Ang-2) plasma Cmax are estimated to be 0.23 (0.07) mcg/mL and 0.22 (0.07) mcg/mL in nAMD and in DME patients, respectively.

• Jan 28, 2022BLABLA761235Genentech Inc

1. 1Off Label Use2,43834%
2. 2No Adverse Event1,92527%
3. 3Retinal Thickening6238.6%
4. 4Visual Impairment5687.8%
5. 5Death3615.0%
6. 6Drug Ineffective3454.8%
7. 7Optical Coherence Tomography Abnormal3384.7%
8. 8Eye Inflammation3314.6%
9. 9Uveitis3264.5%
10. 10Endophthalmitis2473.4%
11. 11Blindness2373.3%
12. 12Vitritis2313.2%
13. 13Vitreous Floaters2243.1%
14. 14Visual Acuity Reduced2183.0%
15. 15Vision Blurred2132.9%

The 10 most recently updated of 55 ClinicalTrials.gov registrations naming Faricimab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Choroidal Neovascularization Secondary to Pathologic Myopia
  Completed · Phase 3 · Interventional · 280 enrolled · Hoffmann-La Roche
  NCT06176352updated 2026-06-09
• A Real-World Study to Gain Clinical Insights Into Faricimab (FaReal Study)
  Recruiting · Observational · 850 enrolled · Hoffmann-La Roche
  NCT06680817updated 2026-06-09
• A Real-World Study to Gain Clinical Insights Into Roche Ophthalmology Products
  Active not recruiting · Observational · 6,000 enrolled · Hoffmann-La Roche
  NCT05476926updated 2026-06-09
• Pre-operative Vabysmo in Patients With Non-clearing Vitreous Hemorrhage Secondary to Proliferative Diabetic Retinopathy
  Enrolling by invitation · Phase 4 · Interventional · 100 enrolled · University of Colorado, Denver
  NCT06191094updated 2026-06-01
• Efficacy of Faricimab in Patients With Subretinal Hyper-reflective Material
  Recruiting · Phase 4 · Interventional · 100 enrolled · Biobizkaia Health Research Institute
  NCT07403825updated 2026-05-28
• A Study to Evaluate the Efficacy and Safety of IBI302 inSubjects With Diabetic Macular Edema（DME）
  Active not recruiting · Phase 2 · Interventional · 150 enrolled · Innovent Biologics Technology Limited (Shanghai R&D Center)
  NCT06908876updated 2026-05-27
• A Study to Investigate Faricimab Treatment Response in Treatment-Naive, Underrepresented Patients With Diabetic Macular Edema
  Active not recruiting · Phase 4 · Interventional · 218 enrolled · Genentech, Inc.
  NCT05224102updated 2026-05-27
• A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of RO7823653 in Participants With Diabetic Macular Edema (DME)
  Recruiting · Phase 1 · Interventional · 93 enrolled · Genentech, Inc.
  NCT07425522updated 2026-05-20
• Faricimab + PRP vs. Vitrectomy + Endolaser for Treatment of PDR
  Recruiting · Phase 3 · Interventional · 426 enrolled · Jaeb Center for Health Research
  NCT06790784updated 2026-05-18
• Intravitreal Faricimab Injections or Fluocinolone Acetonide (0.19 mg) Intravitreal Implants vs Observation for Prevention of VA Loss Due to Radiation Retinopathy
  Recruiting · Phase 3 · Interventional · 600 enrolled · Jaeb Center for Health Research
  NCT05844982updated 2026-05-18

Frequently asked questions

How does Faricimab work?

Faricimab is a humanized bispecific antibody that acts through inhibition of two pathways by binding to VEGF-A and Ang-2. By inhibiting VEGF-A, faricimab suppresses endothelial cell proliferation, neovascularization and vascular permeability.

What is Faricimab used for?

According to FDA labeling, Faricimab carries indications including: VABYSMO is a vascular endothelial growth factor (VEGF) and angiopoietin 2 (Ang-2) inhibitor indicated for the treatment of patients with: VABYSMO is a vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2) inhibitor indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (nAMD) ( 1.1 ) Diabetic Macular Edema (DME) ( 1.2 ) Macular Edema Following Retinal Vein Occlusion (RVO) ( 1.3 ) 1.1 Neovascular (wet) Age-Related Macular Degeneration (nAMD) 1.2 Diabetic Macular Edema (DME) 1.3 Macular Edema Following Retinal Vein Occlusion (RVO). This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Faricimab?

Faricimab is classified as Antineovascularisation agents, Vascular Endothelial Growth Factor Inhibitors, Decreased Endothelial Proliferation.

What are the brand names for Faricimab?

Faricimab is marketed under brand names including Vabysmo.

What are the contraindications for Faricimab?

Faricimab labeling lists contraindications including: Ocular or periocular infection ( 4.1 ) Active intraocular inflammation ( 4.2 ) Hypersensitivity ( 4.3 ) 4.1 Ocular or Periocular Infections VABYSMO is contraindicated in patients with ocular or periocular infections. 4.2 Active Intraocular Inflammation VABYSMO is contraindicated in patients with active intraocular inflammation.. Always consult the full prescribing information and a clinician.