Eylea

Approved Indications

Eylea is used to treat several conditions that affect the retina and can cause vision loss. These conditions often involve the growth of abnormal blood vessels or the leakage of fluid into the eye.

• Wet Age-Related Macular Degeneration (AMD): A condition where abnormal blood vessels grow under the macula and leak fluid or blood, blurring central vision.
• Diabetic Macular Edema (DME): Swelling in the retina caused by fluid leaking from blood vessels in people with diabetes.
• Diabetic Retinopathy (DR): Damage to the blood vessels in the retina due to diabetes, which can lead to vision impairment.
• Macular Edema following Retinal Vein Occlusion (RVO): Swelling in the retina that occurs after a blockage in the veins that carry blood away from the retina.
• Retinopathy of Prematurity (ROP): A condition in premature infants where abnormal blood vessels grow in the retina, which can lead to vision loss or retinal detachment.

The medication is administered by a healthcare professional as an injection into the eye to help manage these conditions and potentially improve or maintain vision.

Blocking Abnormal Vessel Growth

Eylea belongs to a class of medications known as vascular endothelial growth factor (VEGF) inhibitors. In certain eye conditions, the body produces high levels of a protein called VEGF. This protein signals the body to create new blood vessels. However, in the eye, these new vessels are often weak and abnormal.

These abnormal vessels can leak blood and fluid into the retina, which is the light-sensitive tissue at the back of the eye. This leakage causes swelling and damage, leading to vision loss.

The Decoy Mechanism

Eylea acts as a decoy receptor or a trap for specific proteins in the eye. It specifically targets and binds to:

• VEGF-A: The primary protein responsible for new blood vessel growth and increased vascular permeability.
• PlGF (Placental Growth Factor): Another protein that contributes to the growth of abnormal blood vessels and inflammation.

When Eylea binds to these proteins, it prevents them from attaching to their natural receptors on the surface of blood vessel cells. Because the proteins are trapped, they cannot send the signal to grow new vessels or cause existing ones to leak.

Reducing Swelling and Fluid

By blocking these signals, Eylea helps to:

• Decrease the amount of fluid and swelling (edema) in the retina.
• Prevent the formation of new, fragile blood vessels.
• Stop existing abnormal vessels from leaking.

This process helps to stabilize vision and, in many cases, can lead to an improvement in sight by clearing the fluid that interferes with the retina's function.

Common Side Effects

Many people experience mild side effects after receiving an injection of Eylea. These typically affect the treated eye and may include:

• Eye pain or discomfort
• Redness in the white of the eye (conjunctival hemorrhage)
• Blurred vision
• Moving spots or floaters in the field of vision
• A feeling that something is in the eye
• Increased pressure inside the eye

Serious Side Effects

While less common, some side effects require immediate medical attention. Contact a healthcare provider right away if you experience:

• Severe eye pain or swelling
• Sudden loss of vision or significant changes in sight
• Increased sensitivity to light
• Redness that worsens over time
• Discharge from the eye
• Signs of a blood clot, such as sudden numbness, weakness, or difficulty speaking

In rare cases, Eylea can cause serious eye conditions such as an internal eye infection (endophthalmitis), a detached retina, or the development of cataracts. Allergic reactions are also possible and may present as a rash, itching, or swelling of the face and throat.

Serious Eye Conditions

Injections into the eye have been linked to serious infections called endophthalmitis and retinal detachments. Symptoms that require immediate medical attention include eye pain, worsening redness, blurred vision, or increased sensitivity to light.

Eye Pressure and Monitoring

A temporary increase in pressure inside the eye can occur within 60 minutes of an injection. Healthcare professionals typically monitor eye pressure and blood flow to the optic nerve after the procedure.

Contraindications

Eylea should not be used in people who have:

• An infection in or around the eye.
• Active inflammation inside the eye.
• A known allergy to aflibercept or any other ingredients in the product.

Systemic Risks

There is a potential risk of arterial thromboembolic events, such as heart attack or stroke, associated with this class of medication. Although these events occurred infrequently in clinical studies, they remain a consideration for safety monitoring.

Pregnancy and Contraception

Eylea may cause harm to a developing fetus. It is recommended that individuals who can become pregnant use effective birth control before starting treatment, during treatment, and for at least three months after the final injection.

Visual Disturbances

Because the injection and related eye exams can cause temporary vision changes, it is important to wait until vision has cleared before driving or operating machinery.

Pregnancy

It is not known if Eylea will harm an unborn baby, as there are no adequate and well-controlled studies in pregnant women. However, animal studies involving high doses of the medication administered intravenously showed evidence of embryo-fetal toxicity, including birth defects and pregnancy loss. While the dose used in human eye injections is much lower, the potential risk to a fetus cannot be ruled out.

Because of these potential risks, healthcare providers typically recommend that individuals who can become pregnant use effective birth control to prevent pregnancy. Contraception should be used:

• Before the first injection.
• During the entire course of treatment.
• For at least 3 months after the final injection of Eylea.

If you become pregnant while receiving this medication, notify your healthcare provider immediately to discuss the risks and benefits of continuing treatment.

Breastfeeding

It is unknown whether Eylea passes into human breast milk or if it could affect a nursing infant. Because many drugs are excreted in human milk and there is a potential for serious adverse reactions in the infant, a decision must be made whether to discontinue breastfeeding or discontinue the drug. This decision should be made in consultation with a doctor, taking into account the importance of the medication to the mother's health.

Available Forms

Eylea is a sterile solution intended for intravitreal injection, which is a procedure where the medication is injected directly into the eye by a healthcare provider.

The medication is provided in the following forms:

• Single-dose vial: A vial containing the solution for one-time use.
• Single-dose prefilled syringe: A syringe pre-loaded with the medication for one-time use.

A higher-concentration version, Eylea HD, is also available as a solution in a single-dose vial.

FDA Approval and Indications

The U.S. Food and Drug Administration (FDA) first approved Eylea (aflibercept) in 2011. It is currently approved for the treatment of the following conditions:

• Neovascular (Wet) Age-Related Macular Degeneration (AMD): A condition where abnormal blood vessels grow under the retina and leak fluid.
• Macular Edema following Retinal Vein Occlusion (RVO): Swelling of the retina caused by a blockage in the veins that carry blood away from the retina.
• Diabetic Macular Edema (DME): Swelling in the retina that occurs in people with diabetes.
• Diabetic Retinopathy (DR): Damage to the blood vessels in the retina caused by diabetes.
• Retinopathy of Prematurity (ROP): An eye disease that can occur in premature babies.

Regulatory Oversight and Safety

Eylea does not currently have a boxed warning or a Risk Evaluation and Mitigation Strategy (REMS) program. However, the FDA-approved labeling includes important safety information regarding potential risks associated with the injection procedure and the medication itself.

Regulatory guidelines require that Eylea be administered only by a qualified healthcare professional, typically an ophthalmologist, in a controlled clinical setting. This ensures proper monitoring for immediate side effects, such as increased pressure within the eye or rare but serious infections like endophthalmitis. The FDA also monitors reports of arterial thromboembolic events, such as nonfatal stroke or heart attack, which have been observed in clinical trials of VEGF inhibitors.

Factors Influencing Cost

The total price of treatment with Eylea is determined by several variables, including your specific diagnosis and the treatment schedule prescribed by your doctor. Because Eylea must be administered by a healthcare professional in a medical office or clinic, the total cost typically includes the price of the medication plus fees for the injection procedure and the office visit.

Insurance and Medicare Coverage

Most insurance plans, including Medicare Part B, generally cover Eylea when it is determined to be medically necessary. Because it is an injection given by a provider rather than a drug you pick up at a pharmacy, it is usually processed through medical insurance rather than a prescription drug plan. Patients may still be responsible for deductibles, coinsurance, or copayments depending on their specific policy.

Financial Assistance

Financial support options may be available to help reduce out-of-pocket expenses:

• Copay Assistance: Patients with commercial (private) insurance may qualify for copay cards or programs offered by the manufacturer to lower their share of the cost.
• Patient Assistance Programs: For individuals who are uninsured or have limited income, programs may exist to provide the medication at a reduced cost or for free if eligibility requirements are met.

Biosimilar Availability

The FDA has approved biosimilar versions of aflibercept. These medications are highly similar to Eylea and are intended to provide the same clinical benefits. The introduction of biosimilars may offer lower-cost alternatives for patients and healthcare systems, though their availability and coverage can vary by insurance provider.