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EYLEA (aflibercept) Injection For Intravitreal Injection box

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

EYLEA is an anti–vascular endothelial growth factor (anti-VEGF) treatment that is given by injection into the eye and works to block VEGF by trapping it between its molecular arms.

Anti-vascular endothelial growth factor (anti-VEGF)

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 Symptoms of MEfRVO happen as the macula swells with fluid.3,4 Blocking VEGF helps reduce the fluid leaking into the macula.2


Support from EYLEA4U®

If you and your eye doctor decide that 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

Macular Edema following Central Retinal Vein Occlusion (MEfCRVO)

In two clinical studies, 358 people with MEfCRVO received
injections of EYLEA (2 mg) either once every 4 weeks
or
control

Both studies measured the percentage of people gaining at least 15 letters (3 lines) on the eye chart at 6 months compared to the number of letters they saw when each study started.

Macular Edema following Branch Retinal Vein Occlusion (MEfBRVO)

In a clinical study, 181 people with MEfBRVO received
injections of EYLEA (2 mg) either once every 4 weeks
or
control

The study measured the percentage of people gaining at least 15 letters (3 lines) on the eye chart at 6 months compared to the number of letters they saw when the study started.

Patients eye chart scores improved after treatment with EYLEA

At 6 months, 56% to 60% of people treated with EYLEA gained at least 15 letters (3 lines)on the eye chart. 89% to 94% of people treated with EYLEA were able to see the same number of letters or more letters on the eye chart.1

Patients eye chart scores improved after treatment with EYLEA

At 6 months, 53% of people treated with EYLEA gained at least 15 letters (3 lines)on the eye chart. 98% of people treated with EYLEA were able to see the same number of letters or more letters on the eye chart.5

At 6 months, people treated with EYLEA saw, on average, at least 17 more letters

than when each study started.

than when the study started.

The number of letters gained by people treated with EYLEA was much greater than control.

Vision before EYLEA treatment
Vision before EYLEA treatment
Vision after EYLEA treatment
Vision after EYLEA treatment

These results are from 2 clinical studies; your individual results may vary. Discuss with your eye care team if EYLEA is right for you.

These results are from a clinical study; your individual results may vary. Discuss with your eye care team if EYLEA is right for you.


Recommended dosing

It's important to keep with your treatment schedule

The recommended dose of EYLEA for MEfRVO is 2 mg administered by injection in the eye monthly (every 4 weeks).

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. Central retinal vein occlusion (CRVO) symptoms. American Academy of Ophthalmology (AAO EyeSmart) Web site. http://www.aao.org/eye-health/diseases/central-retinal-vein-occlusion-symptoms. Accessed October 5, 2016.
  4. Branch retinal vein occlusion (BRVO) symptoms. American Academy of Ophthalmology (AAO EyeSmart) Web site. http://www.aao.org/eye-health/diseases/branch-retinal-vein-occlusion-symptoms. Accessed October 5, 2016.
  5. Campochiaro PA, Clark WL, Boyer DS, et al. Intravitreal aflibercept for macular edema following branch retinal vein occlusion: the 24-week results of the VIBRANT study. Ophthalmology. 2015;122(3):538-544.