Faricimab
VABYSMO
What it isBispecific intravitreal antibody blocking VEGF-A and angiopoietin-2; wet AMD, diabetic macular edema and retinal vein occlusion.
Why this oneAng-2 blockade distinguishes it from single-target anti-VEGF agents and lets many patients extend to every-three-or-four-month dosing.
What limits itIntravitreal injection risks endophthalmitis, inflammation, retinal detachment and transient pressure elevation.
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Neovascular (wet) age-related macular degeneration (nAMD) | Adults | 6 mg (0.05 mL) intravitreal Q4W ×4 doses | Then, per OCT/visual acuity, 6 mg on one of: weeks 28 & 44; weeks 24, 36 & 48; or weeks 20, 28, 36 & 44 | |
| Diabetic macular edema (DME) | Adults | 6 mg (0.05 mL) intravitreal Q4W for ≥4 doses (or Q4W ×6 doses) | Then extend by up to 4-week increments or reduce by up to 8-week increments based on CST/visual acuity (or Q8W after first 6 doses) | |
| Macular edema following retinal vein occlusion (RVO) | Adults | 6 mg (0.05 mL) intravitreal Q4W (monthly) |
Renal No adjustment needed
Hepatic Undefined
Each prefilled syringe or vial for treatment of a single eye only.
Instructions
- For intravitreal injection by a qualified physician under aseptic technique
- Monitor intraocular pressure and optic nerve head perfusion after injection
- Each prefilled syringe or vial is for single-eye use only; use a new one for the contralateral eye
Contraindications
- Ocular or periocular infections
- Active intraocular inflammation
Cautions
- Endophthalmitis and retinal detachments following intravitreal injection
- Transient increase in intraocular pressure (within 60 minutes)
- Potential risk of arterial thromboembolic events (VEGF inhibition)
- Retinal vasculitis and/or retinal vascular occlusion — discontinue if these develop
Adverse reactions
- Cataract
- Conjunctival hemorrhage
- Vitreous detachment, vitreous floaters
- Intraocular pressure increased, eye pain
- Intraocular inflammation
Pregnancy No adequate data; based on mechanism (VEGF/Ang-2 inhibition) there is potential risk; do not use unless potential benefit outweighs potential risk to the fetus.
Lactation No information on presence in human milk; consider developmental/health benefits of breastfeeding with the mother's clinical need and potential risk.
NO BOXED WARNINGS
Classes and tags
Clinical profile
Mechanism of action: Faricimab ballicule
