Opuviz

Pronunciation: op-u-viz
Generic name: aflibercept
Dosage form: single-dose vial for ophthalmic injection
Drug class: Anti-angiogenic ophthalmic agents

Medically reviewed by Carmen Pope, BPharm. Last updated on Jul 18, 2024.

What is Opuviz?

Opuviz (aflibercept-yszy) is an interchangeable biosimilar to Eylea that may be given by injection every 1 to 2 months to treat the following eye conditions:

• Neovascular (Wet) age-related macular degeneration (AMD) – a condition where new blood vessels grow under the retina where they leak blood and fluid
• Macular edema following retinal vein occlusion (RVO) – a swelling in the retina caused by a blockage in the blood vessels
• Diabetic macular edema (DME) – a build-up of fluid in the retina that is caused by leaking blood vessels
• Diabetic retinopathy (DR) – an eye disorder in diabetics that can lead to a buildup of fluid in the retina and cause blindness.

Opuviz (aflibercept-yszy) works by preventing the formation of new blood vessels under the retina. It does this by blocking vascular endothelial growth factor (VEGF), which is a protein that encourages the growth of new blood vessels. Opuviz helps to stop the growth of these harmful blood vessels, reducing damage to the eye and preserving vision. It belongs to the class of medicines known as VEGF inhibitors.

Opuviz was FDA-approved on May 20, 2024, and is an interchangeable biosimilar to Eylea. A biosimilar is a biological product that is like the reference biologic (in this case Eylea) and for which there are no clinically meaningful differences in terms of safety, purity, and potency. Eylea was FDA-approved on November 18, 2011.

Opuviz side effects

The most common side effects of Opuviz are:

• Broken blood vessels in the eye (conjunctival hemorrhages)
• Eye pain
• Cataracts
• Vitreous detachment (the separation of the vitreous gel from the retina)
• Floaters (small dark shapes that float across your vision)
• Increased pressure inside the eye.

Other Opuviz side effects may include:

• Red or watery eyes

• Blurred vision

• Swelling of the eyelids

• Mild eye pain or discomfort after the injection.

Serious side effects and warnings

You should not use Opuviz if you are allergic to aflibercept, Eylea, Yesafili, Opuviz, or any of the inactive ingredients in these preparations. Get emergency medical help if you have any signs of an allergic reaction to Opuviz such as hives; difficulty breathing; or swelling of your eyes, face, lips, tongue, or throat.

Do not receive Opuviz if you have swelling or redness inside your eyes, or any type of infection (bacterial, fungal, viral) in or around your eyes. Call your doctor at once if you develop:

• eye pain or redness, swelling around your eyes

• sudden vision problems

• seeing flashes of light or "floaters" in your vision, seeing halos around lights

• your eyes may be more sensitive to light

• chest pain

• sudden numbness or weakness, especially on one side of the body

• sudden severe headache, confusion, problems with speech or balance.

There is a possibility that endophthalmitis (a serious inflammation of the intraocular fluids, usually due to infection) and retinal detachments may occur following an intravitreal injection of Opuviz. Call your doctor at once if you have eye pain or redness, swelling or puffiness around your eyes, sensitivity to light, or sudden vision problems at any time during treatment. Arterial thromboembolic events are also possible following intravitreal VEGF inhibitor injections.

Increases in pressure inside the eye (intraocular pressure) have been seen within 60 minutes of an intravitreal injection.

Temporary visual disturbances may occur following an intravitreal injection with Opuviz, or the associated eye examinations. Do not drive or operate machinery until your vision recovers.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Before receiving Opuviz

You should not receive Opuviz if you are allergic to aflibercept, Eylea, Yesafili, Opuviz, or any of the inactive ingredients in these preparations, or if you have:

• swelling inside your eyes

• any type of bacterial, fungal, or viral infection in or around your eyes.

To make sure this medicine is safe for you, tell your doctor if you:

• have had a blood clot or stroke
• have glaucoma or other conditions that increase pressure inside your eyes
• are pregnant or planning to become pregnant
• are breastfeeding.

Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant while using Opuviz. You may need to undertake a pregnancy test if you are a female with childbearing potential. Use effective birth control to prevent pregnancy before your first dose of this medicine. Keep using birth control during treatment and for at least 3 months after your last Opuviz injection.

Breastfeeding

Do not breastfeed while you are using Opuviz.

How is Opuviz administered?

Opuviz is given as an injection into your eye (this is called an intravitreal injection) by a healthcare provider who will use a medicine to numb your eye before giving you the injection. You will receive this injection in your doctor's office or clinic.

• One injection is given into each affected eye.
• If you only have one affected eye, you will only receive one injection.
• If both your eyes are affected, will will receive a separate injection into each eye.
• Your healthcare provider will monitor you for a short time after your injection for side effects.

Opuviz dosage

The usual recommended dose in adults is 2mg (0.05mL) (one injection) into the affected eye(s).

• Opuviz is usually administered every 4 weeks (approximately every 25 to 28 days, monthly) initially, which may be extended to once every 8 weeks (2 months), depending on the condition.
• In some patients, treatment may be extended to one dose every 12 weeks, although this is not as effective as the recommended every 8-week dosing.
• Follow your doctor's dosing instructions very carefully and keep all your appointments.

Related/similar drugs

Vabysmo, Syfovre, triamcinolone ophthalmic, dexamethasone ophthalmic, Eylea, fluocinolone ophthalmic, aflibercept ophthalmic, Lucentis, Izervay, ranibizumab ophthalmic

What happens if I miss a dose?

Call your doctor to reschedule if you miss an appointment for your Opuviz injection.

What happens if I overdose?

An overdose is unlikely because healthcare professionals administer Opuviz. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if you have any concerns.

What should I avoid?

Opuviz may cause blurred vision and may impair your reactions. Avoid driving or hazardous activity until you know how this medicine will affect you.

What other drugs will affect Opuviz?

It is not likely that other drugs you take orally or inject will have an effect on Opuviz used in the eyes. However, many drugs can interact with each other. Tell your doctor about all the medicines you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Storage

Your healthcare provider will store Opuviz in the refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze. Do not use it beyond the date stamped on the carton and container label. Store in the original carton until time of use to protect from light.

Opuviz ingredients

Active: aflibercept-yszy 40 mg/mL.

Inactive: dibasic sodium phosphate (0.008 mg), monobasic sodium phosphate (0.040 mg), polysorbate 20 (0.015 mg), sucrose (4 mg), and water for injection, with a pH of 6.2.

Delivers a dose of 2 mg (0.05 mL) in a single-dose vial. One vial contains more extractable volume than is needed, but only 0.05 mL should be administered into the eye and the rest discarded, otherwise, an overdose may occur. One vial should be used for one eye.

Supplied as a vial only and a vial kit with injection components (filter needle, syringe, injection needle).

Who makes Opuviz?

Samsung Bioepis Co., Ltd. makes Opuviz for Biogen MA Inc.

Opuviz Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There are 2 for Opuviz.

Eylea interchangeable products

Interchangeable biosimilar products can be dispensed by a pharmacist without the intervention of the prescriber of the reference product.

Pharmacy laws for biosimilar prescribing may vary by state.

Eylea biosimilar products

Biosimilar products can only be dispensed in place of the reference product if the healthcare provider specifically prescribes the biosimilar product by name.

Pharmacy laws for biosimilar prescribing may vary by state

Popular FAQ

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• What biosimilars have been approved in the United States?

Further information

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