Vabysmo (faricimab-svoa)

What is Vabysmo?

Vabysmo is a brand-name prescription medication. It’s FDA-approved to treat the following eye conditions in adults:

• wet age-related macular degeneration
• diabetic macular edema, which is a complication of diabetes

Both of these conditions involve leaky blood vessels and edema (swelling) in the eye. Left untreated, damage within the eye and vision loss may occur. For more details about these conditions and how Vabysmo is used to treat them, see the “Vabysmo uses” section below.

Drug details

The active ingredient in Vabysmo is faricimab-svoa. Vabysmo is a type of drug called a dual vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2) inhibitor.

Vabysmo is given by an eye doctor as an intravitreal injection. This is an injection into the eye. The drug comes as a liquid solution in a single-dose vial. Vabysmo comes in one strength of 120 milligrams (mg) per milliliter (mL). Each vial contains a single dose of 6 mg in 0.05 mL of solution.

FDA approval

The Food and Drug Administration (FDA) approved Vabysmo in January 2022.

Effectiveness

For information about the effectiveness of Vabysmo, see the “Vabysmo uses” section below.

Vabysmo generic or biosimilar

Vabysmo is a brand-name biologic drug. It isn’t currently available in a biosimilar or generic form.

Regular drugs, including generics, are typically made using chemicals. Generic drugs are made by producing exact copies of the active ingredient in a brand-name medication.

Biologic drugs are made using living cells. Biologics cannot be copied exactly. So instead of having generic versions, biologic drugs have biosimilars. A biosimilar is similar to the brand-name drug it’s based on. Biosimilars are considered to be as effective and safe as brand-name medications. And like generics, biosimilars often cost less than brand-name drugs.

Vabysmo cost

As with all medications, the cost of Vabysmo can vary. The actual price you’ll pay, including the annual cost, depends on your insurance plan, your location, and your healthcare professional.

Before approving coverage for Vabysmo, your insurance company may require you to get prior authorization. This means that your eye doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the prior authorization request and decide whether the drug will be covered.

If you’re not sure whether you’ll need to get prior authorization for Vabysmo, contact your insurance company.

Financial and insurance assistance

If you need financial support to pay for Vabysmo or help to understand your insurance coverage, help is available.

A patient support program is available for Vabysmo. For more information and to find out if you’re eligible for support, call 833-EYE-GENE (833-393-4363) or visit the program website.

To learn more about saving money on prescriptions, check out this article.

Biosimilar form

Vabysmo isn’t currently available in a generic or biosimilar form.

Regular drugs, including generics, are typically made using chemicals. Generic drugs are made by producing exact copies of the active ingredient in a brand-name medication.

Biologic drugs, such as Vabysmo, are made using living cells. Biologics cannot be copied exactly. So instead of having generic versions, biologic drugs have biosimilars. A biosimilar is similar to the brand-name drug it’s based on. Biosimilars are considered to be as effective and safe as brand-name medications. And like generics, biosimilars often cost less than brand-name drugs.

Vabysmo side effects

Vabysmo can cause mild or serious side effects. The following lists contain some of the key side effects that may occur with Vabysmo. These lists do not include all possible side effects.

For more information about the possible side effects of Vabysmo, talk with your eye doctor or pharmacist. They can give you tips on how to manage any side effects that may be concerning or bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Vabysmo, you can do so through MedWatch.

Mild side effects

Below is a partial list of mild side effects of Vabysmo. To learn about other mild side effects, talk with your eye doctor or pharmacist, or view Vabysmo’s prescribing information.

Mild side effects of Vabysmo can include:

• temporary vision changes, such as blurriness
• bright red spot on the white area of your eye due to bleeding in the conjunctiva (clear outer layer of the eye)
• eye pain or irritation
• floaters in your vision
• eye watering or itching
• foreign body sensation (a feeling of something in your eye)
• mild allergic reaction*

Most of these side effects may go away within a few days to a couple of weeks. However, if they become more severe or don’t go away, talk with your eye doctor or pharmacist.

* For more information about allergic reaction and Vabysmo, see “Allergic reaction” below.

Serious side effects

Serious side effects from Vabysmo aren’t common, but they can occur. Call your eye doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

• Serious problems resulting from blood clots in arteries. Examples include stroke, heart attack, or blood vessel problems that may, in rare cases, be fatal. Stroke symptoms and heart attack symptoms can include:
  • chest pain
  • pain that goes down your left arm
  • sweating
• Serious eye problems, such as a detached retina (separation of the retina from the back of the eye) and infection inside the eyeball. Symptoms can include:
  • eye redness
  • sensitivity to light
  • eye pain
  • changes in vision, such as blurred vision or seeing sparks of light
• Temporary increase in intraocular pressure (pressure in the eye).
• Severe allergic reaction.*

* For details about allergic reaction and Vabysmo, see “Allergic reaction” below.

ALLERGIC REACTION

As with most drugs, some people can have an allergic reaction after receiving Vabysmo. It isn’t clear if this side effect occurred in clinical trials of this drug.

Symptoms of a mild allergic reaction can include:

• skin rash
• itchiness
• flushing

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

• swelling under your skin, typically in your eyelids, lips, hands, or feet
• swelling of your tongue, mouth, or throat
• trouble breathing
• eye redness or swelling

Call your eye doctor right away if you have an allergic reaction to Vabysmo, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Vabysmo dosage

The Vabysmo dosage your eye doctor prescribes will depend on several factors. These include the type and severity of the condition Vabysmo is treating.

The following information describes dosages that are commonly used or recommended. Your eye doctor will determine the best dosing frequency to fit your needs.

Drug forms and strengths

Vabysmo is given by an eye doctor as an intravitreal injection (an injection into the eye). The drug comes as a liquid solution in a single-dose vial.

Vabysmo comes in one strength of 120 milligrams (mg) per milliliter (mL). Each vial contains a single dose of 6 mg in 0.05 mL of solution.

Dosage for wet age-related macular degeneration

For wet age-related macular degeneration (AMD), you’ll receive 6-mg doses of Vabysmo. You’ll usually have one dose every 4 weeks for the first four doses.

You’ll likely have eye exams 2 and 3 months after the fourth dose. These exams will include vision testing and optical coherence tomography (OCT), which is a scan that takes pictures of your retina. Based on the results, your eye doctor can determine how well Vabysmo is working for you.

Then you’ll usually receive Vabysmo according to one of the following dosing schedules:

• every 16 weeks
• every 12 weeks
• every 8 weeks
• every 4 weeks*

Your eye doctor will determine the best dosing frequency for you. They’ll perform eye exams regularly throughout your treatment to check how well the drug is working for your wet AMD.

* Vabysmo’s clinical trials looked at different dosing schedules. One dose every 4 weeks wasn’t more effective for wet AMD than one dose every 8 weeks.

Dosage for diabetic macular edema

For diabetic macular edema (DME), you’ll receive 6-mg doses of Vabysmo. You’ll likely receive one dose every 4 weeks for the first four or six doses.

After the initial doses, you’ll have an eye exam. This exam will include vision testing and an OCT scan. Based on the results, your eye doctor can determine how well the drug is working for your DME. Then you’ll likely follow one of two possible dosing schedules:

• Variable dosing schedule: After the first four doses, your eye doctor may gradually increase the time between doses. They may do this until you’re receiving one dose every 8, 12, or 16 weeks for a total of 52 weeks. The number of weeks between doses may increase or decrease throughout your treatment based on the results of regular eye exams with OCT.
• Fixed dosing schedule: After the first six doses, you’ll receive one dose every 8 weeks for 28 weeks.

Your eye doctor will determine the best dosing schedule for you. They’ll also examine your eyes regularly throughout treatment to check how well the drug is working for your DME.

Some people may continue to receive one dose of Vabysmo every 4 weeks after the initial four to six doses. However, in the drug’s clinical trials, one dose every 4 weeks wasn’t more effective for DME than one dose every 8 weeks.

What if I miss a dose?

If you miss an appointment for a Vabysmo injection, call your eye doctor as soon as possible to reschedule. It’s usually okay to receive your dose within 7 days of your scheduled date.

To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm or using a calendar. You could also download a reminder app on your phone.

Will I need to receive this drug long term?

Vabysmo is meant to be used as a long-term treatment. If you and your eye doctor determine that Vabysmo is safe and effective for you, you’ll likely receive it long term.

How Vabysmo works

Vabysmo is used to treat wet age-related macular degeneration (AMD) and diabetic macular edema (DME). Both of these conditions involve leaky blood vessels and edema (swelling) in the eye. Left untreated, damage within the eye and vision loss may occur.

Vabysmo is a type of drug called a dual vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2) inhibitor. VEGF and Ang-2 are types of proteins that contribute to edema in the eye in people with AMD or DME.

Vabysmo’s mechanism of action (how it works) is to block the action of VEGF and Ang-2. This may help slow or stop the damage from eye edema. Within the eye, Vabysmo helps:

• slow the growth of new blood vessels
• reduce leaking from blood vessels
• decrease swelling in blood vessels

How long does it take to work?

Vabysmo starts working with your first dose. In clinical trials, some people had improved vision after one dose. Other people may not notice an improvement for several months.

Alternatives to Vabysmo

Other drugs are available that can treat your condition. Some may be a better fit for you than others. If you’re interested in finding an alternative to Vabysmo, talk with your eye doctor. They can tell you about other medications that may work well for you.

Note: Some of the drugs listed here are used off-label to treat these specific conditions. Off-label drug use is when a drug that’s approved by the Food and Drug Administration (FDA) is prescribed for a purpose other than its approved use.

Alternatives for wet age-related macular degeneration

Examples of other drugs that may be used to treat wet age-related macular degeneration include:

• aflibercept (Eylea)
• bevacizumab (Avastin)
• brolucizumab (Beovu)
• ranibizumab (Lucentis, Susvimo)
• ranibizumab-nuna (Byooviz)
• ranibizumab-eqrn (Cimerli)

Alternatives for diabetic macular edema

Examples of other drugs that may be used to treat diabetic macular edema include:

• dexamethasone (Ozurdex)
• bevacizumab (Avastin)
• ranibizumab (Lucentis)
• ranibizumab-eqrn (Cimerli)

Common questions about Vabysmo

Here are answers to some frequently asked questions about Vabysmo.

Is Vabysmo prescribed with a loading dose to start?

Yes. A loading dosage is a higher dosage at the start of treatment to help a drug begin working quickly.

When you start receiving Vabysmo, you’ll likely have one dose every 4 weeks for at least the first four doses. The drug is usually given more often at the beginning of treatment rather than the later phase of treatment. The dosing schedule is meant to help Vabysmo start reducing edema (swelling) in your macula sooner.

Your eye doctor can help answer any additional questions you have about your Vabysmo dosage.

Do Vabysmo injections cure the conditions they’re prescribed to treat?

There isn’t a cure for wet age-related macular degeneration (AMD) or diabetic macular edema (DME), but Vabysmo can help slow their progression. The drug may improve your vision or help prevent any vision loss from becoming worse.

If you have questions about what to expect from Vabysmo treatment, talk with your eye doctor.

How quickly does Vabysmo work?

Vabysmo starts working with your first dose. In clinical trials, some people had improved vision after one dose. Other people may not notice an improvement for several months.

Your eye doctor will perform eye exams regularly throughout your treatment to check how well the drug is working for you.

Vabysmo interactions

Vabysmo is not known to interact with other medications, herbs, supplements, or foods. The manufacturer did not list any interactions in the drug’s prescribing information.

However, this doesn’t mean that interactions won’t be recognized in the future. For example, new drugs could be approved that interact with Vabysmo.

Before starting Vabysmo treatment, talk with your eye doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also, tell them about any vitamins, herbs, and supplements you take. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, talk with your eye doctor or pharmacist.

Vabysmo uses

The Food and Drug Administration (FDA) approves prescription drugs such as Vabysmo to treat certain conditions.

Vabysmo for wet age-related macular degeneration

Vabysmo is FDA-approved for use in adults to treat an eye condition called neovascular age-related macular degeneration (AMD). It’s commonly called wet AMD. The condition may also be referred to as exudative macular degeneration.

Wet AMD explained

Wet AMD occurs when new, leaky blood vessels grow rapidly under the macula. The macula is a small area in the middle of the retina. And the retina is the lining of the back of your eye.

The macula is important for clearly seeing fine detail in front of you. With wet AMD, the leaky blood vessels cause the macula to swell.

Wet AMD occurs most often in people ages 55 years and older.

Symptoms of wet AMD may include:

• blurred vision
• objects appearing crooked or wavy when you look straight ahead
• colors looking faded
• trouble seeing in dim light

Wet AMD is a progressive condition, meaning that it tends to get worse over time. If the condition isn’t treated, central vision loss may occur. Central vision involves seeing objects straight ahead. Wet AMD doesn’t affect your peripheral vision, which involves seeing objects off to the sides.

Treatments such as Vabysmo are available to help slow the progression of wet AMD. To learn more about managing wet AMD, visit our eye health hub.

Effectiveness for wet AMD

In clinical trials, Vabysmo was shown to be an effective treatment for wet AMD. For details on how Vabysmo performed in these trials, read the drug’s prescribing information.

Vabysmo for diabetic macular edema

Vabysmo is also FDA-approved for use in adults to treat an eye condition called diabetic macular edema (DME).

Diabetic macular edema explained

If you have diabetes, your blood sugar levels can become too high. Over time, high blood sugar levels can lead to complications of diabetes, including eye problems such as DME.

High blood sugar levels can damage blood vessels in the retina (the lining of the back of your eye). This causes blood vessels to leak, leading to a buildup of fluid that causes swelling of the macula. The macula is a small area in the middle of the retina.

DME can occur in people of any age. The condition can affect people who have type 1 or type 2 diabetes.

Symptoms of DME may include:

• blurred vision
• objects appearing crooked or wavy when you look straight ahead
• colors looking faded
• trouble seeing in dim light

With DME, your vision gets worse over time. With prompt treatments for DME, vision loss can usually be slowed down or even reversed. Your doctor and eye doctor can also provide information about managing your blood sugar levels and keeping them within a healthy range.

To learn more about DME, visit our eye health hub.

Effectiveness for diabetic macular edema

In clinical trials, Vabysmo was shown to be an effective treatment for DME. For details on how Vabysmo performed in these trials, read the drug’s prescribing information.

Vabysmo and children

Vabysmo is FDA-approved for use only in adults. This drug has not been studied in people younger than age 18 years.

If you’d like to learn about treatment options for children with DME, talk with your child’s eye doctor.

Vabysmo and alcohol

Vabysmo isn’t known to interact with alcohol.

If you drink alcohol, talk with your eye doctor about how much is safe to consume during your treatment with Vabysmo.

How Vabysmo is given

You’ll receive Vabysmo at your eye doctor’s office or a clinic. Your eye doctor will give you the drug as an intravitreal injection (an injection into the eye).

Before administering Vabysmo, your eye may be numbed with an anesthetic. Your doctor will discuss options for anesthesia with you prior to your Vabysmo injections. You may also be given an antimicrobial drug to help prevent infection. Then your eye doctor will inject the drug into your eye using a very thin needle.

During the injection, you may feel pressure in your eye. Afterward, your eye doctor will monitor the pressure in your eye. If the pressure becomes too high, they can treat it. This involves removing fluid from your eye with a needle, which quickly lowers the pressure.

Keep in mind that Vabysmo injections may cause temporary vision problems, such as blurred vision. Because of this side effect, you should not drive or use machinery until you recover. This means you’ll need to arrange for someone to take you home after each injection appointment.

When it’s given

Vabysmo is given once every 1 to 4 months. Your eye doctor will determine the best dosing frequency to fit your needs.

To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm and putting the appointment on your calendar. You could also download a reminder app on your phone.

Vabysmo and pregnancy

It’s unknown whether Vabysmo is safe to receive during pregnancy. However, because of the way the drug works in the body, Vabysmo may cause harmful effects in a developing fetus. In animal studies, pregnancy loss occurred when the drug was given to pregnant animals. For this reason, the drug typically isn’t used unless you and your doctor determine that the benefits outweigh the risks.

If you’re pregnant or planning to become pregnant, talk with your eye doctor before starting Vabysmo treatment. They’ll likely recommend a different option.

Vabysmo and fertility

While it isn’t known for sure, Vabysmo may affect fertility.

If you plan to have children, talk about this with your eye doctor before you start receiving Vabysmo. They’ll help determine the right treatment for you.

Vabysmo and birth control

It’s unknown whether Vabysmo is safe to receive during pregnancy. If you or your partner can become pregnant, talk with your doctor about your birth control needs during Vabysmo treatment.

For more information about receiving Vabysmo during pregnancy, see the “Vabysmo and pregnancy” section above.

For females receiving Vabysmo. If you’re female* and can become pregnant, you should use birth control before starting Vabysmo treatment. You should also continue using birth control during treatment and for at least 3 months after your last dose.

For males receiving Vabysmo. The manufacturer of Vabysmo hasn’t given birth control recommendations for males* receiving the drug. If you’re male and your sexual partner can become pregnant, talk with your doctor. They can advise you on your birth control needs during Vabysmo treatment.

* Sex and gender exist on spectrums. Use of the term “female” and “male” in this article refers to sex assigned at birth.

Vabysmo and breastfeeding

Vabysmo treatment isn’t recommended while breastfeeding. It’s not known whether the drug passes into breast milk or whether it can affect breast milk production.

If you’re breastfeeding, talk with your doctor and eye doctor. They can help you decide how to feed your child and determine what treatments are right for your condition.