Eylea HD

Eylea HD is used to treat neovascular (wet) age-related macular degeneration (nAMD), diabetic macular edema (DME), diabetic retinopathy (DR), and macular edema following retinal vein occlusion (RVO). It is a long-acting eye injection given as an intravitreal injection (an injection into the eye) every 1 to 5 months by an eye specialist.

• Eylea HD is NOT Approved for Retinopathy of Prematurity (ROP). Only Eylea is approved for this.

Eylea HD (aflibercept) was approved on August 18, 2023. There is no generic or biosimilar.

Eylea HD is a higher-strength (8 mg) than Eylea injection (2 mg). This higher-strength allows for longer intervals between treatments for many patients, and potentially fewer injections. See What is the difference between Eylea and Eylea HD? for more information.

Eylea HD is given as an injection into your eye, 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 other clinic setting.

For a short time after your injection, your eyes will be checked regularly to make sure the injection has not caused any side effects.

Do not receive Eylea HD if:

• You are allergic to aflibercept, Eylea, Eylea HD, or an Eylea biosimilar, or any of the inactive ingredients in the eye injection
• You have active inflammation inside your eye
• 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 not known if Eylea HD affects male or female fertility.

Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant while using Eylea HD. You may need to take a pregnancy test before using Eylea HD 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 4 months after your last Eylea HD injection.

Breastfeeding

Do not breastfeed while you are using Eylea HD.

Common Side Effects

The most common side effects of Eylea HD are:

• Red or watery eyes
• Blurred vision and temporary visual disturbances
• 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 haemorrhage).

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 HD may cause the following serious side effects:

• Increased Intraocular Pressure. Eylea HD may increase the pressure of fluids inside the eye (intraocular pressure), usually within 60 minutes of an intravitreal injection.
• Endophthalmitis, Retinal Detachment, and Retinal Vasculitis. Eylea HD may cause an eye condition called endophthalmitis, which is a serious inflammation of the fluids inside the eye. Retinal detachments and retinal vasculitis (inflammation of the blood vessels in the retina) with or without blockage have also occurred following eye injections. 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.
• Thromboembolic events. Eylea HD may increase the risk of arterial blood clots, including stroke and heart attack. In clinical trials, clot rates were generally lower with Eylea HD than with Eylea injection 2mg.
• Allergic Reactions. Eylea HD 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.

Call your doctor at once if you get any of the following symptoms following an Eylea HD 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.

Eylea works by binding to VEGF receptors and blocking all VEGFR-1 ligands, including VEGF-A and PGF (Placental Growth Factor), both of which promote blood vessel growth. Clinical trials have shown Eylea injection reduces abnormal blood vessel growth and leakage in the retina, helping to manage retinal conditions such as wet AMD, DME, and DR.

Dose of Eylea HD for Wet Age-Related Macular Degeneration (nAMD)

• Initial: 8 mg via intravitreal injection every 4 weeks (28 +/- 7 days) for the first 3 doses.
• Maintenance: 8 mg via intravitreal injection every 8 to 16 weeks +/- 1 week.
• Some patients may not maintain a response with extended dosing and may benefit from resuming every 4-week dosing.
• Extended dosing intervals (8 mg once every 20 weeks +/- 1 week) may be considered after 1 year of successful response based on visual and anatomic outcomes.

Eylea HD Dosage for Diabetic Macular Edema (DME)

• Initial: 8 mg via intravitreal injection every 4 weeks (28 +/- 7 days) for the first 3 doses.
• Maintenance: 8 mg via intravitreal injection every 8 to 16 weeks +/- 1 week.
• Some patients may not maintain a response with extended dosing and may benefit from resuming every 4-week dosing.
• Extended dosing intervals (8 mg once every 20 weeks +/- 1 week) may be considered after 1 year of successful response based on visual and anatomic outcomes.

Eylea HD Dosage for Diabetic Retinopathy (DR)

• Initial: 8 mg via intravitreal injection every 4 weeks (28 +/- 7 days) for the first 3 doses.
• Maintenance: 8 mg via intravitreal injection every 8 to 12 weeks +/- 1 week.
• Some patients may not maintain a response with extended dosing and may benefit from resuming every 4-week dosing.

Eylea HD Dosage for Macular Edema Following Retinal Vein Occlusion (RVO)

• Initial: 8 mg via intravitreal injection every 4 weeks (28 +/- 7 days) for the first 3 to 5 doses.
• Maintenance: 8 mg via intravitreal injection every 8 weeks +/- 1 week.
• Some patients may not maintain a response with extended dosing and may benefit from resuming every 4-week dosing.

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

Eylea HD may cause blurred vision and may impair your reactions or driving skills. Avoid driving or hazardous activities soon after the injection.

Interactions with Eylea HD are unlikely, but you should 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.

Active: aflibercept 114.3 mg/mL solution

Inactive: a buffer containing arginine hydrochloride (0.737 mg), histidine (0.04 mg), L-histidine hydrochloride monohydrate (0.093 mg), polysorbate 20 (0.021 mg), sucrose (3.5 mg), and water for injection with a pH of 5.8.

Eylea HD does not contain an antimicrobial preservative.

One Eylea HD injection contains 8 mg (0.07 mL of 114.3 mg/mL solution) in a single-dose vial.

Eylea HD is manufactured by Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY 10591-6707. U.S. License Number 1760.

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 HD.

Eylea (aflibercept) - Regeneron Pharmaceuticals, Inc.

View Eylea information in detail.

Eylea HD (aflibercept) - Regeneron Pharmaceuticals, Inc.

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.

Yesafili (aflibercept-jbvf) - Biocon Biologics Inc.

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

View Ahzantive information in detail.

Pavblu (aflibercept-ayyh) - Amgen Inc.

View Pavblu information in detail.

Yesafili (aflibercept-jbvf) - Biocon Biologics Inc.

View Yesafili information in detail.