Eylea is an injectable eye preparation that is given by a healthcare provider every one to two months that may be used to treat the following 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
• Retinopathy of Prematurity (ROP) – an eye condition in premature babies that affects the retina.

Eylea HD is a long-acting injectable form of aflibercept that only needs to be given once every 2 to 4 months after an initial dosing period. This allows patients to receive less frequent injections for similar visual gains, and anatomic improvements, without an increased risk of side effects. Eylea HD is approved to treat:

• Neovascular (Wet) Age-Related Macular Degeneration
• Diabetic Macular Edema 
• Diabetic Retinopathy.

The active ingredient in Eylea and Eylea HD, aflibercept, is a vascular endothelial growth factor (VEGF) inhibitor that is made from a human antibody fragment. It works by keeping new blood vessels from forming under the retina (a sensory membrane that lines the inside of the eye).

Eylea was first approved on November 18, 2011, and Eylea HD was first approved on August 18, 2023.

You should not use Eylea or Eylea HD if you are allergic to aflibercept, if you have swelling or redness inside your eyes, or any type of infection (bacterial, fungal, viral) in or around your eyes.

There is a possibility that endophthalmitis (a serious inflammation of the intraocular fluids, usually due to infection) and retinal detachments may occur following intravitreal 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. Arterial thromboembolic events are also possible following intravitreal VEGF inhibitor injections.

Increases in intraocular pressure have been seen within 60 minutes of an intravitreal injection.

Infants with ROP may need extended periods of monitoring after injections with Eylea.

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

Eylea and Eylea HD are given as an injection into your eye. 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 periodically to make sure the injection has not caused any side effects.

Dosage for Eylea

Eylea is usually administered every 4 weeks (approximately every 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.

The dosage for ROP is 0.4 mg (0.01 mL or 10 microliters) 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.

Dosage for Eylea HD

Eylea HD is usually administered every 4 weeks (approximately every 28 days +/- 7 days) for the first 3 months, then once every 8 to 12 weeks for DR or 8 to 16 weeks for wAMD and DME.

You should not use Eylea or Eylea HD if you are allergic to aflibercept, or if you have:

• swelling inside your eyes; or

• 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 ever had:

• a blood clot or stroke; or

• glaucoma or other conditions that increase pressure inside your eyes.

Tell your doctor if you are pregnant or plan to become pregnant while using Eylea or Eylea HD. 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 Eylea injection, or 4 months after your last Eylea HD injection.

Do not breastfeed while you are using Eylea or Eylea HD.

Call your doctor for instructions if you miss an appointment for your Eylea or Eylea HD injection.

An overdose is unlikely because Eylea and Eylea HD are administered by healthcare professionals. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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

Get emergency medical help if you have any signs of an allergic reaction to Eylea or Eylea HD: hives; difficult breathing; swelling of your eyes, face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• 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; or

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

Less serious Eylea or Eylea HD side effects may include:

• red or watery eyes;

• blurred vision;

• swelling of the eyelids; or

• mild eye pain or discomfort after the injection.

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 FDA at 1-800-FDA-1088.