Pronunciation: vah-BYE-smo
Generic name: faricimab-svoa
Dosage form: intravitreal injection
Drug class: Anti-angiogenic ophthalmic agents

Medically reviewed by Carmen Pope, BPharm. Last updated on Oct 30, 2023.

What is Vabysmo?

Vabysmo  (faricimab-svoa) is a vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2) inhibitor that is given by injection into the eye to treat adults with:

• Neovascular (Wet) age-related macular degeneration (nAMD)
• Diabetic macular edema (DME), or
• Macular edema following retinal vein occlusion.

Vabysmo targets and inhibits two pathways related to vision-threatening retinal conditions. These pathways lead to excess production of two proteins, Ang-2 and VEGF-A, which can harm your central vision. Too much VEGF-A causes leaky blood vessels, damaging the macula at the back of your eye. Excess Ang-2 makes blood vessels unstable, leading to leakage, inflammation, and new vessel growth. Vabysmo helps prevent the growth of these unstable vessels, reducing the risk of eye diseases like nAMD, DME, and macular edema after retinal vein occlusion.

Vabysmo was first FDA-approved on January 28, 2022, and was the first bispecific antibody to be approved for treating eye disorders.

Warnings

Do not receive Vabysmo if you:

• have an infection in or around your eye
• your eye is red, inflamed, or painful
• are allergic to Vabysmo or any of the ingredients in Vabysmo.

Eye infections (endophthalmitis) or separation of the layers of the retina (retinal detachment) can occur following eye injections such as Vabysmo. Call your healthcare provider right away if you have:

• increasing eye pain
• vision loss
• sensitivity to light
• redness in the white of the eye.

Temporary increases in the pressure in the eye (also called intraocular pressure) within 60 minutes of an injection have been reported with Vabysmo.

There is a risk of serious, sometimes fatal, blood clots, such as heart attacks or strokes (thromboembolic events) associated with the use of VEGF inhibitors, such as Vabysmo.

It is not known if Vabysmo is safe and effective in children.

Before receiving Vabysmo

Before receiving Vabysmo, tell your healthcare provider about all your medical conditions, including if you:

• have an eye infection
• have red eyes
• are pregnant, plan to become pregnant, are breastfeeding, or plan to breastfeed.

Pregnancy and breastfeeding

There is a potential risk to the unborn baby from Vabysmo. Your healthcare provider may conduct a pregnancy test before starting treatment if there is a chance you could be pregnant.

For females and males of reproductive potential - patients should use birth control before their first injection, during their treatment with Vabysmo, and for 3 months after their last dose of Vabysmo. Vabysmo should not be used during pregnancy unless the potential benefit to the patient outweighs the potential risk to the fetus.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Vabysmo passes into breast milk. Talk to your doctor about the best way to feed your baby if you receive Vabysmo.

How should I receive Vabysmo?

Vabysmo is administered by a healthcare professional and is given as an injection into your eye. Your healthcare provider should anesthetize your eye first, so the injection is usually painless.

• A separate syringe will be used for each eye.
• Immediately after Vabysmo is administered you will be monitored to check for elevation in your intraocular pressure - the fluid pressure in your eye.
• Vabysmo is usually given initially every 4 weeks for the first 4-6 doses and then as advised by your healthcare professional.

Dosage

Neovascular (wet) AMD

• The recommended dose is 6 mg (0.05 mL of 120 mg/mL solution) every 4 weeks approximately for the first 4 doses.
• Your healthcare provider will then conduct optical coherence tomography and visual acuity evaluations after 8 and 12 weeks to guide further dosing.
• Some patients may need to continue with injections every 4 weeks.

Diabetic Macular Edema

There are two main dosage regimens for Vabysmo:

• 6 mg administered by intravitreal injection every 4 weeks for at least 4 doses. Further dosing is guided by optical coherence tomography
• 6 mg administered by intravitreal injection every 4 weeks for the first 6 doses, followed by 6 mg dose via intravitreal injection at intervals of every 8 weeks (2 months) over the next 28 weeks. Further dosing is guided by optical coherence tomography.

What should I avoid while receiving Vabysmo?

Your vision may be impaired after receiving an eye injection or after an eye exam. Do not drive or use machinery until your vision has recovered sufficiently.

What are the side effects of Vabysmo?

The most common side effects occurring in 5% or more people receiving  Vabysmo were:

• Cataracts (15%)
• Blood in the white of the eye (conjunctival hemorrhage) (8%).

These are not all the possible side effects of Vabysmo. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to Genentech at 1-888-835-2555.

What should I avoid after receiving Vabysmo?

Your vision may be impaired after receiving Vabysmo or after an eye exam. Do not drive or use machinery until your vision has recovered sufficiently.

What other drugs will affect Vabysmo?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

See the prescribing information for a full list of interactions.

Storage

Store in the refrigerator between 2°C to 8°C (36°F to 46°F).

Do not freeze. Do not shake. Keep the vial in the original carton to protect it from light.

Before use, the unopened glass vial of Vabysmo may be kept at room temperature, 20°C to 25°C (68°F to 77°F), for up to 24 hours. Once drawn up, the injection must be given immediately.

Ingredients

Active: faricimab 120mg/mL

Other: Each single-dose vial is designed to deliver 0.05 mL (50 microliters) of solution containing 6 mg faricimab-svoa, L-histidine (155 mcg), L-methionine (52.2 mcg), polysorbate 20 (20 mcg), sodium chloride (73.1 mcg), D-sucrose (2.74 mg) and Water for Injection, adjusted to pH 5.5 with acetic acid.

Does not contain an anti-microbial preservative.

Manufacturer

Genetech, Inc., a member of the Roche Group.

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