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EYLEA (aflibercept) Injection For Intravitreal Injection packaging

EYLEA has been studied in more than 3,000 people with certain diseases of the retina.

EYLEA is a prescription medication given by injection into the eye. You should not use EYLEA if you have an infection in or around the eye, eye pain or redness, or known allergies to any of the ingredients in EYLEA, including aflibercept.

How EYLEA works

There are many treatment options available to treat vision loss from DME and DR in DME. Many doctors choose anti–vascular endothelial growth factor (anti-VEGF) therapy.

EYLEA is an anti-VEGF treatment that is given by injection into the eye and works by blocking VEGF. EYLEA blocks VEGF by trapping it between its molecular arms.

Vascular endothelial growth factor trapped by molecular arms

What is VEGF?

VEGF is a protein made by the blood vessels that, at high levels, can cause abnormal blood vessels to grow in the eye and leak fluid.2,4 Symptoms of DME and DR in DME happen as the macula swells with fluid. Blocking VEGF helps reduce the fluid leaking into the macula.2,4


Support from EYLEA4U®

If you and your eye doctor decide EYLEA is right for you, we have multiple support options that may be able to help. Whether you have government insurance (like Medicare), private health insurance, or no coverage for EYLEA, we are here to help.


Vision improvements seen with EYLEA

In two clinical studies, 862 people with DME received
injections of EYLEA (2 mg) either once every 8 weeks after 5 initial monthly doses or once every 4 weeks
or
laser treatment

Both studies measured the number of letters on the eye chart people could read before and after treatment with EYLEA at 1 and 2 years.

On average, people treated with EYLEA in the studies gained about 10 letters on the eye chart at 1 year, which continued through 2 years with treatment

These results are from 2 clinical studies; your individual results may vary. Discuss with your eye care team what treatment schedule with EYLEA may be right for you.

More than a third of people improved their vision after treated with EYLEA

On average, more than a third of people treated with EYLEA in the studies improved their vision by at least 15 letters (or 3 lines) on the eye chart at 1 year.

People who received only laser treatment gained, on average, about 1 more letter on the eye chart compared with the number of letters they saw before treatment.

Eye laser treatment

Results from the clinical studies were seen with an average of 8 to 9 treatments of EYLEA 2 mg dosed every 8 weeks (after 5 initial monthly doses) in the first year and 5 more injections with the same dosing schedule in the second year.5,6

After 2 years, the severity of DR was reduced in some patients with EYLEA, and some patients experienced improvement in DR.


Recommended dosing

It's important to keep with your treatment schedule

EYLEA is the only FDA-approved treatment for DME and DR in DME7 with a recommended dose of 2 mg administered by injection in the eye every 2 months (8 weeks) following 5 initial monthly (every 4 weeks) injections. EYLEA may be dosed once per month, but in most patients, additional benefit was not seen with this dosing plan. Some patients may need monthly (every 4 weeks) dosing after the first 5 months (20 weeks).

After 5 initial monthly doses, some patients may need only half as many injections of EYLEA. Your eye care team will determine the EYLEA dosing schedule that's right for you.

Your eye care team will want to see you regularly to check your vision and also check your treatment progress with EYLEA. Work with your eye care team to make sure you can keep your appointments and stay on your recommended treatment schedule.


Safety Information for EYLEA

EYLEA® (aflibercept) Injection is a prescription medication administered by injection into the eye. You should not use EYLEA if you have an infection in or around the eye, eye pain or redness, or known allergies to any of the ingredients in EYLEA, including aflibercept.

Injection into the eye with EYLEA can result in an infection in the eye and retinal detachment (separation of retina from back of the eye). Inflammation in the eye has been reported with the use of EYLEA.

In some patients, injections with EYLEA may cause a temporary increase in eye pressure within 1 hour of the injection. Sustained increases in eye pressure have been reported with repeated injections, and your doctor may monitor this after each injection.

There is a potential risk of serious and sometimes fatal side effects related to blood clots, leading to heart attack or stroke in patients receiving EYLEA.

Serious side effects related to the injection procedure with EYLEA are rare but can occur including infection inside the eye and retinal detachment.

The most common side effects reported in patients receiving EYLEA are increased redness in the eye, eye pain, cataract, moving spots in the field of vision, increased pressure in the eye, and vitreous (gel-like substance) detachment.

As with all therapeutic proteins, there is a potential for an immune response in patients treated with EYLEA.

It is important that you contact your doctor right away if you think you might be experiencing any side effects, including eye pain or redness, light sensitivity, or blurring of vision, after an injection.

Important Safety Information
  • EYLEA® (aflibercept) Injection is a prescription medication administered by injection into the eye. You should not use EYLEA if you have an infection in or around the eye, eye pain or redness, or known allergies to any of the ingredients in EYLEA, including aflibercept.
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Important Safety Information
  • EYLEA® (aflibercept) Injection is a prescription medication administered by injection into the eye. You should not use EYLEA if you have an infection in or around the eye, eye pain or redness, or known allergies to any of the ingredients in EYLEA, including aflibercept.
  • Injection into the eye with EYLEA can result in an infection in the eye and retinal detachment (separation of retina from back of the eye). Inflammation in the eye has been reported with the use of EYLEA.
  • In some patients, injections with EYLEA may cause a temporary increase in eye pressure within 1 hour of the injection. Sustained increases in eye pressure have been reported with repeated injections, and your doctor may monitor this after each injection.
  • There is a potential risk of serious and sometimes fatal side effects related to blood clots, leading to heart attack or stroke in patients receiving EYLEA.
  • Serious side effects related to the injection procedure with EYLEA are rare but can occur including infection inside the eye and retinal detachment.
  • The most common side effects reported in patients receiving EYLEA are increased redness in the eye, eye pain, cataract, moving spots in the field of vision, increased pressure in the eye, and vitreous (gel-like substance) detachment.
  • It is important that you contact your doctor right away if you think you might be experiencing any side effects, including eye pain or redness, light sensitivity, or blurring of vision, after an injection.
  • EYLEA is for prescription use only. For additional safety information, please talk to your doctor and see the full Prescribing Information for EYLEA.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Indications

EYLEA® (aflibercept) Injection is a prescription medicine approved for the treatment of patients with:

  • Wet Age-related Macular Degeneration (AMD): The recommended dose for EYLEA is 2 mg administered by injection in the eye every 2 months (8 weeks) following 3 initial monthly (every 4 weeks) injections. EYLEA may be dosed once per month, but in most patients, additional benefit was not seen with this dosing plan. Some patients may need monthly (every 4 weeks) dosing after the first 3 months (12 weeks).
  • Macular Edema following Retinal Vein Occlusion (RVO): The recommended dose for EYLEA is 2 mg administered by injection in the eye monthly (every 4 weeks).
  • Diabetic Macular Edema (DME) and Diabetic Retinopathy (DR) in patients with DME: The recommended dose for EYLEA is 2 mg administered by injection in the eye every 2 months (8 weeks) following 5 initial monthly (every 4 weeks) injections. EYLEA may be dosed once per month, but in most patients, additional benefit was not seen with this dosing plan. Some patients may need monthly (every 4 weeks) dosing after the first 5 months (20 weeks).
Please see the full Prescribing Information for EYLEA.

The information contained herein is provided for general educational purposes. If you have any questions, talk to your doctor.

References:
  1. Data on file. Regeneron Pharmaceuticals, Inc.
  2. Facts about macular edema. National Institutes of Health, National Eye Institute Web site. https://nei.nih.gov/health/macular-edema/fact_sheet. Accessed October 5, 2016.
  3. What treatments are available for diabetic eye disease? American Foundation for the Blind, VisionAware Web site. http://www.visionaware.org/info/your-eye-condition/diabetic-retinopathy/treatments-for-diabetic-eye-disease/125. Accessed October 5, 2016.
  4. Facts about diabetic eye disease. National Institutes of Health, National Eye Institute Web site. https://nei.nih.gov/health/diabetic/retinopathy. Accessed October 5, 2016.
  5. Korobelnik JF, Do DV, Schmidt-Erfurth U, et al. Intravitreal aflibercept for diabetic macular edema. Ophthalmology. 2014;121(11):2247-2254.
  6. Brown DM, Schmidt-Erfurth U, Do DV, et al. Intravitreal aflibercept for diabetic macular edema: 100-week results from the VISTA and VIVID studies. Ophthalmology. 2015;122(10):2044-2052.
  7. Lucentis® (ranibizumab injection) full U.S. Prescribing Information. Genentech, Inc. October 2016.