About EYLEA and Diabetic Retinopathy About EYLEA and Diabetic Retinopathy Understanding DR

EYLEA & DR

Learn more about the #1 prescribed FDA-approved anti-vascular endothelial growth factor (anti-VEGF) treatment for patients with DR in DME.

ABOUT EYLEA

EYLEA has been studied in more than 3,000 people with certain diseases of the retina, and has been shown to help improve vision. Early detection, timely treatment, and appropriate follow-up care may help reduce the severity of the disease.

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 DR may occur as blood vessels swell and leak fluid. Blocking VEGF helps reduce the leaking fluid.

EYLEA may be able to help improve your Diabetic Retinopathy (DR)

The Stages of DR

Your doctor can detect the extent of your disease by taking pictures of the back of your eye. These images will help your doctor determine what stage of DR you have.

During your appointment, your doctor may describe the severity of your DR with various stages. DR can progress to different stages over time. With early detection and treatment of DR, along with appropriate follow-up care, the chance of DR getting worse may be reduced.

These stages are based on the Diabetic Retinopathy Severity Scale.

Healthy
In a healthy eye there are no bulges in the blood vessels and no visual symptoms.

Healthy blood vessels with
no bulges

No visual symptoms

Mild
In mild non-proliferative diabetic retinopathy tiny bulges protrude from the vessel walls in the retina.

Small bulges are seen in
blood vessel walls as well as
other signs in the retina

You might not experience any visual symptoms at this stage—but Diabetic Retinopathy is still present and can get worse over time, particularly if it’s not managed

Moderate
In moderate non-proliferative diabetic retinopathy more changes are seen in the blood vessels in the retina, and small spots of blood can become more visible.

More changes are seen in the
blood vessels in the retina,
and small spots of blood
can become more visible

You might not experience any visual symptoms at this stage—but Diabetic Retinopathy is still present and can get worse over time, particularly if it’s not managed. Diabetic Macular Edema can occur at any stage of Diabetic Retinopathy and can cause blurry vision and other symptoms

Moderately Severe
In moderately severe non-proliferative diabetic retinopathy more blood vessels in larger areas of the retina show changes, bleeding in the retina, or beading of veins can occur.

More blood vessels in larger areas of the retina show changes

Leaking of blood in the retina in 2-3 sections

A few veins develop an uneven shape, making them look like beads on a string

Visual symptoms may appear at this stage

Severe
In severe non-proliferative diabetic retinopathy (with no signs of proliferative DR) many of the blood vessels in the retina show visible changes, severe bleeding in the retina, or definite beading of veins can occur.

Many of the blood vessels in the retina show visible changes

More severe leakage of blood into the retina occurs

A few veins develop an uneven shape, making them look like beads on a string in 2 or more sections of the retina

Visual symptoms are usually present

Proliferative
In proliferative diabetic retinopathy increased growth of new damaged blood vessels and/or bleeding in the space between the lens and the retina of the eye can occcur.

Increased growth of new, damaged blood vessels

Bleeding in the space between the lens and the retina of the eye can occur

Visual symptoms are usually present

Diabetic Macular Edema (DME) is a complication of DR, and can happen at any stage. DME occurs if the macula, the area of the retina at the back of the eye, swells with fluid leaked from damaged blood vessels.

  • DR Without DME
  • DR With DME

EYLEA helped DR patients without DME reduce DR severity

A clinical study of 402 people with moderately severe to severe nonproliferative Diabetic Retinopathy (NPDR) evaluated EYLEA in patients who had DR without DME. Patients received two different dosing schedules of EYLEA and were compared to patients who did not receive EYLEA treatment (control group).

  • At 6 months of treatment, 58% of EYLEA patients improved compared to 6% in the control group
  • At 1 year of treatment, 80% of EYLEA patients* improved compared to 15% in the control group

*Patients received EYLEA every 2 months after 5 monthly doses.

Improvement was defined as at least a 2-step improvement on the DR Severity Scale from baseline.

The image below is an example of a 2-step improvement from Severe DR to Moderate DR:

Image demonstrating a 2-step improvement on the Diabetic Retinopathy Severity Scale from Severe DR to Moderate DR. Image demonstrating a 2-step improvement on the Diabetic Retinopathy Severity Scale from Severe DR to Moderate DR.

The image below is an example of a 2-step improvement from Moderately Severe DR to Mild DR:

Image demonstrating a 2-step improvement on the Diabetic Retinopathy Severity Scale from Moderately Severe DR to Mild DR. Image demonstrating a 2-step improvement on the Diabetic Retinopathy Severity Scale from Moderately Severe DR to Mild DR.

EYLEA reduced the chance of progression in DR patients without DME

People treated with EYLEA had a reduced chance of progressing to a more serious stage of DR.

2.4% of patients treated with EYLEA* developed a serious eye complication compared to 20.1% of patients not treated with EYLEA.

*Patients received EYLEA every 2 months after 5 initial monthly doses

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

EYLEA helped DR patients with DME improve their vision

In 2 clinical studies, 862 people with DR and 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.

Researchers also evaluated changes in overall DR. After 2 years, the severity of DR was reduced in some patients with EYLEA.

This improvement was measured as at least a 2-step improvement on the DR Severity Scale from baseline.

The image below is an example of a 2-step improvement from Severe DR to Moderate DR:

Image demonstrating a 2-step improvement on the Diabetic Retinopathy Severity Scale. Image demonstrating a 2-step improvement on the Diabetic Retinopathy Severity Scale.

The image below is an example of a 2-step improvement from Moderately Severe DR to Mild DR:

Image demonstrating a 2-step improvement on the Diabetic Retinopathy Severity Scale. Image demonstrating a 2-step improvement on the Diabetic Retinopathy Severity Scale.

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

Recommended dosing

IT’S IMPORTANT TO KEEP UP WITH YOUR TREATMENT SCHEDULE

The recommended dose for EYLEA in DR is 2 mg (0.05 mL) administered by injection in the eye every 4 weeks (approximately every 28 days, monthly) for the first 5 injections followed by 2 mg (0.05 mL) via 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).

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-14281h US-LEA-14281h

 

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