• Eylea is a VEGF (vascular endothelial growth factor) inhibitor that helps to trap and block VEGF. By inhibiting VEGF, Eylea suppresses the growth of abnormal blood vessels and the potential for retinal fluid leakage. It is given by intravitreal (into the eye) injection. Specifically, Eylea is a recombinant fusion protein that targets VEGF and placental growth factor (PlGF).

• VEGF is a protein created by many cells in the body. When levels of VEGF are elevated in your eyes, it can cause blood vessels to swell and leak fluid and lead to the formation of abnormal blood vessels. This can cause damage to your retina, which is a layer of cells lining the back of your eye that senses light. Damage to your retina can lead to blurring of your vision and possible blindness.

• Eylea is given as an injection into the eye. Your doctor will wash and numb your eye before the injection, and give you antibiotic eye drops. You may feel a bit of pressure while you are receiving the injection but it should not be painful. You may need to receive Eylea injections every 4, 8 or 12 weeks. Your doctor will tell you your dosing schedule.

• Eylea (aflibercept) from Regeneron is approved by the FDA to treat five different eye diseases driven by VEGF-inhibition that may affect vision loss, including:

  • Wet age-related macular degeneration (Wet AMD)
  • Diabetic retinopathy (DR)
  • Diabetetic macular edema (DME)
  • Macular edema following retinal vein occlusion
  • Retinopathy of prematurity (ROP) in preterm infants

• Eylea treatment for Wet AMD may involve fewer eye injections per year compared to other Wet AMD treatments. Eylea is usually injected every 8 weeks, but some patients may be able to have injections every 12 weeks after 1 year of treatment. Local injection into your eye will help to prevent side effects from occurring in other parts of your body.

• Anti-VEGF injections like Eylea are one of the most effective ways to reduce or reverse vision loss from wet AMD.

• Eylea was first approved by the FDA in 2011, so your ophthalmologist (MD eye doctor) should have good experience using this medicine. Clinical studies for each use have been done to show the effectiveness of this medicine compared to other treatments or compared to laser surgery.

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• This medicine may raise your chances for a very bad or even deadly health problem, like blood clots that may result in a heart attack or stroke.

• After Eylea administration, you may be at risk of developing serious eye problems (called endophthalmitis or retinal detachment). If your eye becomes red, sensitive to light, painful, or develops a change in vision, seek medical care right away from an ophthalmologist (eye doctor).

• Your doctor will monitor you for serious side effects such as increased blood pressure in your eye (intraocular hypertension) after injection.

• Like all medicines, Eylea may be associated with side effects. Not everyone will experience all of these side effects. The most common side effects reported with this medicine include: conjunctival hemorrhage (a red spot on your eye from bleeding from blood vessels), eye pain, eye redness, cataract, vitreous (gel-like substance) detachment, vitreous floaters (moving spots in the field of vision), and increased intraocular pressure.

• Because Eylea is expensive, your health insurance may require that you start treatment with less expensive therapies like bevacizumab (brand name: Avastin). Contact your health insurance provider to determine the preferred first line treatments for your condition.

• This medicine must be given at your doctor’s office, and you’ll probably need to take someone with you to drive you home after your appointment.

• This medicine may cause harm to an unborn baby if you take it while you are pregnant. Females of reproductive potential are advised to use effective contraception (birth control) prior to the first dose, during treatment, and for at least 3 months AFTER the last eye injection of Eylea.

Note: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. View complete list of side effects

• You should not use Eylea if you have an infection in your eye, eye pain or redness, or are allergic to aflibercept or other ingredients in Eylea.

• Contact your doctor right away if you think you might be having any side effects, including eye pain or redness, light sensitivity, or blurring of vision, after an injection.

• After your Eylea injection or eye exams, you may have temporary changes in your vision. Do not drive or use machinery until you have clear eyesight. Arrange for someone to drive you to and from your appointments. You may want to have dark glasses to wear for your ride home as your eyes will be sensitive to light.

• Your doctor may give you a paper grid to put up on your refrigerator to routinely check your eyesight. Ask your doctor how to use this grid to check your vision.

• Talk to your doctor about costs associated with Eylea. Eylea is expensive but if you have insurance your plan may help you pay for it or the manufacturer may offer financial assistance. The manufacturer Regeneron may be able to offer financial assistance or a copay card to help lower your costs, if you qualify. You can call 1-855-EYLEA4U (1-855-395-3248) Monday through Friday 9 AM to 8 PM ET to learn more.

• You may have additional fees associated with the eye doctor appointments and administration of the medicine into your eye.

• Tell your doctor and pharmacist about all of the medicines you take, including prescription, over-the-counter (OTC), natural products, vitamins and dietary supplements. Discuss your history of health problems with your healthcare team. Your doctor and pharmacist should check to make sure that it is safe for you to take this drug with all of your drugs and health problems.

• Do not start, stop, or change the dose of any drug without checking with your doctor.

• Wet age-related macular degeneration (Wet AMD): For the treatment of macular degeneration, Eylea was tested in two clinical trials involving over 2,400 patients. Patients were randomized to either Eylea 2 mg or Lucentis (ranibizumab), with a primary endpoint of clearness of vision after one year. Eylea was found to be as effective as Lucentis.

  • For Wet AMD, Eylea has been shown to clinically improve vision, which may improve your ability to read and see letters more clearly. In studies, 94% of Eylea patients maintained their vision after 1 year. Vision improvements have been maintained up to 4 years in patients who continued therapy.

• Diabetic macular edema: In Phase 3 studies evaluating 862 patients with diabetic macular edema (DME), Eylea was compared to macular laser photocoagulation (control group).

  • After one year, visual acuity measurements (BCVA) were statistically significantly improved compared to the control group and were similar to each other.
    • Patients in the Eylea groups gained, on average, the ability to read about two additional lines (15 more letters) on an eye chart compared with almost no change in the control group.

• Diabetic retinopathy (in patients without DME): Eylea was studied in a Phase 3 trial with 402 people with diabetic retinopathy (without DME). Improvement was defined as at least a 2-step improvement in the diabetic retinopathy severity scale.

  • Overall, 58% of patients improved at 6 months compared to 6% in the control group. At one year, 80% of patients receiving Eylea improved compared to 15% in the control group.
  • In addition, those who received Eylea reduced the risk of continuing to a more serious stage of diabetic retinopathy.

• Diabetic retinopathy (in patients with DME): In two clinical studies, participants with diabetic retinopathy (DR) with diabetic macular edema (DME) randomly received treatment with Eylea or a control treatment.

  • Overall, at one-year with continued treatment, 576 patients treated with Eylea saw 10 or more extra letters on an eye chart compared to before treatment started. Over one-third of patients saw an additional 15 or more letters.

• Macular edema following retinal vein occlusion: This medicine has been studied in patients with Macular Edema following Central Retinal Vein Occlusion (MEfCRVO) and in patients with Macular Edema following Branch Retinal Retinal Vein Occlusion (MEfBRVO).

  • MEfCRVO: Eylea was compared to a control group in a Phase 3 studies in 358 patients with MEfCRVO. After 6 months, 94% of patients treated with Eylea maintained their eye vision, up to 60% of patients saw 15 or more letters on an eye chart compared to before treatment, and on average people saw 17 or more letters.
  • MEfBRVO: Eylea was compared to a control group in a Phase 3 studies in 181 patients with MEfBRVO. After 6 months, 98% of patients treated with Eylea maintained their eye vision, 53% of patients saw 15 or more letters on an eye chart compared to before treatment, and on average people saw 17 or more letters.

• Retinopathy of prematurity (ROP): FIREFLEYE and BUTTERFLEYE Phase 3 studies: In 233 infants with ROP , treatment groups received either Eylea 0.4 mg intravitreal injection (into the gel part of the eye) or laser photocoagulation in an open label, parallel group fashion.

  • In both studies, close to 80% of infants who received Eylea or laser treatment achieved an absence of both active ROP and unfavorable structural outcomes at 52 weeks of age (better than expected without treatment).
  • Neither trial demonstrated superiority or inferiority of one arm compared to the other arm.

• No drug interactions have been reported for Eylea (aflibercept ophthalmic) by the manufacturer. It is unlikely that other drugs you take by mouth or by injection will have an effect on Eylea injection used in the eyes.
• However, this does not mean no interactions exist. Always consult your healthcare provider to determine any significant drug interactions with your medications.