Eylea
Pronunciation: EYE-lee-AH
Generic name: aflibercept ophthalmic
Dosage forms: single-dose pre-filled syringe for ophthalmic injection, single-dose vial for ophthalmic injection
Drug class: Anti-angiogenic ophthalmic agents
What is Eylea?
Eylea is used to treat neovascular (wet) age-related macular degeneration (nAMD) and is FDA-approved for several other eye conditions that involve the retina such as:
- macular edema following retinal vein occlusion (RVO)
- diabetic macular edema (DME)
- diabetic retinopathy (DR)
- retinopathy of prematurity (ROP).
Eylea is given as an injection into the eye every 1 to 2 months by an eye specialist.
Eylea gained FDA approval on November 18, 2011.
Eyela FDA approvals
- Neovascular (Wet) age-related macular degeneration (AMD) – a condition where new blood vessels grow under the retina and 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
- Retinopathy of prematurity (ROP) – an eye condition in premature babies that affects the retina.
Eylea biosimilars
Eylea has five biosimilars (these are like a generic version).
- Two of these, Opuviz and Yesafili, are designated as interchangeable biosimilars.
- Three others - Ahzantive, Enzeevu and Pavblu are approved as non-interchangeable biosimilars.
- Unlike Eylea, these biosimilars are not approved for ROP.
See Does Eylea have a biosimilar? for more information.
Mechanism
Eylea works by inhibiting a signal protein produced by multiple cells called VEGF that stimulates the growth of new blood vessels.
- Eylea binds to the VEGF receptor and blocks VEGF-A and PlGF (Placental Growth Factor) - another blood vessel-promoting protein.
- Clinical trials have shown it reduces abnormal blood vessel growth and leakage in the retina.
- This helps manage conditions like wet age-related macular degeneration (AMD), diabetic macular edema, and diabetic retinopathy.
Eylea belongs to the drug class called Vascular Endothelial Growth Factor (VEGF) inhibitors.
Eylea vs Eylea HD
Eylea HD (approved August 18, 2023) is a longer-acting, higher-dose form of Eylea that does not have to be given as often. See What is the difference between Eylea and Eylea HD?
Eylea side effects
The most common side effects of Eylea are:
- red or watery eyes
- blurred vision
- swelling of the eyelids
- mild eye pain or discomfort after the injection
- cataracts
- increased eye pressure
- floaters
- vitreous detachment (when the gel-like substance inside your eye starts to pull away from the back of the eye)
- scratches or damage to the clear front part of your eye
- bleeding in the front (conjunctival haemorrhage) or back of your eye (retinal hemorrhage).
Clinical trials have also reported a temporary increase in blood pressure following eye injections (see Does Eylea and Eylea HD raise blood pressure?).
Serious side effects and warnings
Eylea may cause an increase in the pressure of the fluids inside the eye (intraocular pressure), usually within 60 minutes of an intravitreal injection.
Temporary visual disturbances may occur following an intravitreal injection with Eylea. Do not drive or operate machinery until your vision recovers.
Eylea may cause an eye condition called endophthalmitis, which is a serious inflammation of the fluids inside the eye. Retinal detachments have also occurred following eye injections and blood clots in the arteries are also possible. 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.
Eylea may cause an allergic reaction. Get emergency medical help if you have any signs of an allergic reaction such as hives, difficulty breathing, or swelling of your eyes, face, lips, tongue, or throat.
Do not receive an eye injection 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 get any of the following symptoms following an Eylea injection:
-
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.
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.
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Before receiving Eylea
You should not receive Eylea if you are allergic to aflibercept, Eylea, Eylea HD, Opuviz, Yesafili, Ahzantive, Enzeevu, or Pavblu.
Do not receive Eylea if:
- your eyes feel swollen
- you have an 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.
It is unknown if this medication affects male or female fertility.
Pregnancy
Tell your doctor if you are pregnant or plan to become pregnant while using Eylea. You may need to take a pregnancy test before receiving this injection if you are a female who can get pregnant.
You should use effective birth control to prevent pregnancy before your first dose of this medicine, during treatment and for at least 3 months after your last Eylea injection.
Breastfeeding
Do not breastfeed while you are using Eylea.
How is Eylea administered?
Eylea is given as an injection into your eye. This is called an intravitreal injection.
- Your doctor 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.
For a short time after your injection, your eyes will be checked regularly to make sure the injection has not caused any side effects.
Dosing information
The usual recommended adult dose of Eylea is 2mg (0.05mL) (one injection) into each affected eye.
Eylea dosage for nAMD:
Initial: 2 mg every 4 weeks (approximately every 28 days) for the first 3 months.
Maintenance: 2 mg every 8 weeks (2 months). Some patients may need 1 injection every 4 weeks (1 month).
After 1 year of effective treatment, some patients may be treated with 1 dose every 12 weeks, although this is not as effective as the recommended 8-week dosing interval.
Eylea dosage for macular edema following RVO:
Initial and maintenance: 2 mg every 4 weeks (approximately every 25 days).
Eylea dosage for DME and DR:
Initial: 2 mg every 4 weeks (approximately every 28 days) for the first 5 injections.
Maintenance: 2 mg every 8 weeks (2 months). Some patients may need 1 injection every 4 weeks (1 month).
Eylea dosage for ROP:
Initial: 0.4 mg (0.01 mL) administered by intravitreal injection.
- Treatment may be given to both eyes on the same day and repeated if needed.
- The treatment interval between doses injected into the same eye should be at least 10 days.
What happens if I miss a dose?
Call your doctor to reschedule if you miss an appointment for your Eylea injection.
What happens if I overdose?
An overdose is unlikely because Eylea is administered by healthcare professionals.
What should I avoid?
Eylea 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 Eylea?
It is not likely that other drugs you take orally or inject will have an effect on Eylea 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.
Ingredients
Eylea ingredients
Active: aflibercept 40 mg/mL.
Inactive: 10 mM sodium phosphate, 40 mM sodium chloride, 0.03% polysorbate 20, and 5% sucrose with a pH of 6.2.
The single-dose glass vial is designed to deliver 0.05 mL (50 microliters) of the solution containing 2 mg of aflibercept.
Eylea does not contain an anti-microbial preservative.
Manufacturer
Eylea is manufactured by Regeneron Pharmaceuticals, which is based in Tarrytown, New York. Other notable drugs from Regeneron include:
- Dupixent (dupilumab) - for treating severe eczema, asthma, and certain nasal conditions
- Libtayo (cemiplimab) - for treating certain types of skin cancer
- Praluent (alirocumab) - for lowering cholesterol
- REGEN-COV (casirivimab and imdevimab) - a COVID-19 antibody treatment.
Eylea 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 Eylea.
Eylea (aflibercept) - Regeneron Pharmaceuticals, Inc.
Formulation type | Strength |
---|---|
Pre-Filled Syringe | 2 mg/0.05 mL |
Single-Dose Vial | 2 mg/0.05 mL |
Eylea HD (aflibercept) - Regeneron Pharmaceuticals, Inc.
Formulation type | Strength |
---|---|
Single-Dose Vial | 8 mg/0.07 mL |
View Eylea HD information in detail.
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.
Opuviz (aflibercept-yszy) - Samsung Bioepis Co., Ltd.
Formulation type | Strength |
---|---|
Single-Dose Vial | 2 mg/0.05 mL |
View Opuviz information in detail.
Yesafili (aflibercept-jbvf) - Biocon Biologics Inc.
Formulation type | Strength |
---|---|
Single-Dose Vial | 2 mg/0.05 mL |
View Yesafili information in detail.
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
Ahzantive (aflibercept-mrbb) - Formycon AG
Formulation type | Strength |
---|---|
Single-Dose Vial | 2 mg/0.05 mL |
View Ahzantive information in detail.
Enzeevu (aflibercept-abzv) - Sandoz Inc.
Formulation type | Strength |
---|---|
Pre-Filled Syringe | 2 mg/0.05 mL |
Single-Dose Vial | 2 mg/0.05 mL |
View Enzeevu information in detail.
Pavblu (aflibercept-ayyh) - Amgen Inc.
Formulation type | Strength |
---|---|
Pre-Filled Syringe | 2 mg/0.05 mL |
Single-Dose Vial | 2 mg/0.05 mL |
View Pavblu information in detail.
Popular FAQ
How many Eylea injections can you have?
Eylea is usually injected every 4 or 8 weeks based on your condition. Some patients with wet AMD who do well may be eligible for injections every 12 weeks after 1 year of treatment. Continue treatment as long as directed by your doctor. Eylea or Eylea HD for wet AMD may involve fewer eye injections per year compared to other wet AMD treatments.
What is the difference between Vabysmo and Eylea?
Vabysmo (faricimab) targets vascular endothelial growth factor (VEGF) and angiopoietin-1, whereas Eylea (afibercept) targets VEGF and placental growth factor (P1GF). Both agents are used to treat conditions such as macular degeneration (AMD) and diabetic macular edema and are given by intravitreal injection (into the gel part of the eye). Continue reading
What’s the difference between Eylea, Eylea HD, and Avastin?
Eylea, Eylea HD, and Avastin may all be used to treat neovascular (wet) age-related macular degeneration (AMD), as injections into the eye (intravitreal injections). Both Eylea and Eylea HD are FDA-approved for this indication, but use of Avastin is off-label (not an FDA-approved indication - although it has been used for this purpose since 2005). Eylea HD is a longer acting version of Eylea. Continue reading
What are anti-VEGF drugs (VEGF inhibitors)?
Anti-VEGF drugs slow the abnormal growth of blood vessels associated with certain cancers and degenerative eye conditions, such as age-related macular degeneration. Anti-VEGF stands for anti-vascular endothelial growth factor. Continue reading
How long does Eylea or Eylea HD take to work?
Eylea and Eylea HD usually work within 3 months, with some people noticing improvements in as little as one month of treatment, depending on the condition being treated. For some conditions, it may take up to 6 months before a significant difference is seen. Continue reading
Does Medicare cover Eylea injections?
Medicare usually covers costs of Eylea or Eylea HD after you meet your yearly Part B deductible. Then you will usually pay 20% of the Medicare-approved amount for the drug and any medical services. Your costs may vary depending on if you have insurance copays, coinsurance or administration fees. Continue reading
What is the difference between Eylea and Eylea HD?
Eylea HD is a higher dose, longer-acting formulation of Eylea that has been approved to treat Neovascular (Wet) Age-Related Macular Degeneration (wAMD), Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR). Eylea is approved to treat these conditions in addition to Macular Edema Following Retinal Vein Occlusion (RVO) and Retinopathy of Prematurity (ROP). Continue reading
When do the Eylea and Eylea HD patents expire?
Eylea patents are due to run out from 2023 to 2039; however, these should not be taken as definite dates as there are many ways drug companies can extend their patents, for example, by changing the formulation of their product. A new Eylea HD patent, US11103552B2 which relates to high concentration VEGF receptor fusion protein containing formulations, has a patent expiry date of 15 May 2039. Continue reading
Does Eylea and Eylea HD raise blood pressure?
Eylea and Eylea HD injections into the eye (intravitreal) are associated with a substantial but temporary increase in blood pressure in some patients. Increases in intraocular pressure (the pressure inside the eye) have also been seen within 60 minutes of an injection of Eylea or Eylea HD. Continue reading
References
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