About EYLEA and Diabetic Macular Edema About EYLEA and Diabetic Macular Edema

EYLEA & DME

Learn more about the #1 prescribed FDA-approved anti-vascular endothelial growth factor treatment for patients with Diabetic Macular Edema (DME).

ABOUT EYLEA

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

EYLEA is a prescription medicine 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 by blocking VEGF. EYLEA blocks VEGF by trapping it between its molecular arms.

Anti-vascular endothelial growth factor (anti-VEGF) treatment

WHAT IS VEGF?

VEGF is a protein that, at high levels, can cause blood vessels to leak fluid and also result in the growth of abnormal blood vessels. Symptoms of DME happen as the macula swells with fluid. Blocking VEGF helps reduce the fluid leaking into the macula.

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.

Eye chart before EYLEA anti-VEGF.
Letters gained on eye chart after EYLEA anti-VEGF measured 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 1/3 of patients treated with EYLEA showed vision improvements on the eye chart at 1 year.

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.

Patients receiving laser treatment improved by 1 letter on the eye chart.

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.

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.

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 UP WITH YOUR TREATMENT SCHEDULE

The recommended dose for EYLEA in DME is 2 mg (0.05 mL) administered by intravitreal injection every 4 weeks (approximately every 28 days, monthly) for the first 5 injections followed by 2 mg (0.05 mL) via intravitreal injection once every 8 weeks (2 months). Although EYLEA may be dosed as frequently as 2 mg every 4 weeks (approximately every 25 days, monthly), additional efficacy was not demonstrated in most patients when EYLEA was dosed every 4 weeks compared to every 8 weeks. Some patients may need every 4 week (monthly) dosing after the first 20 weeks (5 months).

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 medicine 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, vitreous (gel-like substance) detachment, vitreous floaters, moving spots in the field of vision, and increased pressure in the eye.

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.

FINANCIAL SUPPORT FROM EYLEA4U®

MONITORING YOUR VISION IS IMPORTANT

EYLEA4U is a comprehensive support program with several resources available to help eligible patients with the cost of EYLEA.

Learn about vision tests.

Learn about some of the tests your doctor may use to diagnose and monitor your condition, and what you can do at home.

IMPORTANT SAFETY INFORMATION
  • EYLEA® (aflibercept) Injection is a prescription medicine 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, vitreous (gel-like substance) detachment, vitreous floaters, moving spots in the field of vision, and increased pressure in the eye.
  • 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 2 mg (0.05mL) is a prescription medicine approved for the treatment of patients with Wet Age-related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR).

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.

For U.S. Residents Only

EYLEA AND EYLEA4U are registered trademarks of Regeneron Pharmaceuticals, Inc.

© 2019, Regeneron Pharmaceuticals, Inc. All rights reserved.
777 Old Saw Mill River Road,
Tarrytown, NY 10591

05/2019
US-LEA-14281b(2) US-LEA-14281b(2)

 

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