Eylea is a type of anti-VEGF injection, which is injected into the eye, to treat various retinal conditions like Wet age-related macular degeneration, diabetic retinal disease, and retinal vein occlusions. It can help to slow the vision loss that can occur due to these conditions.
Eylea is the brand name for the Aflibercept injection, developed by Regeneron Pharmaceuticals Inc. It received FDA approval for ocular use in 2011 and is also known as VEGF Trap-Eye.
In certain retinal diseases, there is an excess production of VEGF (vascular endothelial growth factor) by the retinal cells. VEGF causes formation of new blood vessels, and causes the existing blood vessels to become leaky, resulting in swelling at the macula (central point of the retina, responsible for fine vision, colour vision etc) Anti VEGF agents act by blocking the effects of VEGF and thus cause a reduction in the fluid and leakage, and regression of the abnormal new blood vessels. As the damaged blood vessels gradually recede so does the swelling in the retina.
Eylea (Aflibercept) blocks both VEGF-A, VEGF B and Placental growth factor (PlGF). It traps these molecules and prevents them from binding to and activating their receptors, and thus it is also known as VEGF Trap Eye. It opposes the effect of VEGF-A and PIGF would have in the eye, and is a very effective anti VEGF drug.
Intravitreal Eylea injection is FDA approved for the treatment of Wet ARMD (Neovascular AMD), Macular edema due to Diabetic retinopathy and retinal vein occlusions, and Retinopathy Of Prematurity (ROP). It can also be used to treat Choroidal new vessels caused by angiod streaks, pathological myopia, or traumatic choroidal rupture, and for regression of new vessels in Proliferative diabetic retinopathy and Neovascular Glaucoma.
ARMD stands for Age-Related Macular Degeneration. It is of 2 types :
Here is a more detailed note on ARMD.
Macular edema is the swelling or accumulation of fluid in the central part of the retina, known as the macula. The macula is the most critical part of the retina, responsible for the majority of our vision. Any disease that affects the macula can significantly impair vision.
The fluid accumulation occurs due to two main reasons:
The recommended dose of Eylea is 2 mg in 0.05 ml given by intravitreal injection. The dosing schedule i.e. how often the injection has to be repeated, can differ based on the disease being treated.
Typically, 3 main approaches are used for giving intravitreal anti-VEGF injections. Treatment usually starts with an initial loading dose of at least three injections given four weeks apart. After that, one of three treatment schedules can be followed:
Fixed dosing regimens require continuous monthly or bimonthly injections for at least one year. However, as this requires a large number of injections, most ophthalmologists prefer one of the flexible treatment schedules mentioned below.
A “reactive” pro re nata (PRN) regimen, or treatment on an as-needed basis, requires monthly monitoring visits. Treatment is reinstated when disease activity recurs. While the patient visits monthly for evaluation, the injection is given only if disease activity is present.
A T&E regimen typically begins with three or more consecutive monthly injections until disease inactivity is established. The treatment interval is then gradually extended in increments of 2 to 4 weeks, up to a maximum interval of 12 to 16 weeks
Treatment intervals are shortened when disease activity recurs. Anti-VEGF injections are administered at every scheduled visit, regardless of disease activity. The ultimate goal is to maintain the patient on 3-4 injections per year.
Increasingly, T&E is the preferred option for doctors globally because it allows the extension of treatment intervals while reducing the overall number of clinic visits.
However, if visual and anatomic outcomes indicate that the patient is no longer benefiting from continued treatment, Eylea should be discontinued.
While Avastin is a monoclonal antibody and Accentrix is an antibody fragment, Eylea is a fusion protein. It is created by fusing VEGF receptor 1 and 2 with the Fc portion of an antibody, allowing it to trap all isoforms of VEGF-A, VEGF-B, as well as placental growth factor (PlGF). This differs from Avastin and Accentrix, which act only on VEGF-A.
Eylea has 100 times more binding capacity to the receptor compared to previous anti-VEGF agents. It also has a much longer half-life, resulting in a longer duration of action. These factors lead to a reduced frequency of dosing. The anti-VEGF activity of Eylea can last up to 12 weeks, compared to 4 weeks with Accentrix or Avastin.
Eylea is an anti-VEGF drug known as Aflibercept or VEGF Trap-Eye. It blocks all isoforms of VEGF, has a greater binding affinity compared to Ranibizumab, and offers a longer duration of action.
Before starting your Eylea treatment, make sure to inform your doctor or healthcare provider if you:
You should not be given Eylea if:
There is limited information about the safety of using Eylea in pregnant women. Eylea should not be used during pregnancy unless the benefit outweighs the risk to the baby. Discuss this with your doctor before starting treatment with Eylea. Women of childbearing potential should use effective contraception during their treatment with Eylea. If you are treated with the 2 mg dose of Eylea, you should continue using effective contraception for at least 3 months after the last injection. If you are treated with the 8 mg dose, you should continue using effective contraception for at least 4 months after the last injection.
The use of Eylea Injection is not recommended during breastfeeding, as small amounts of Eylea may enter breast milk, and its effects on a newborn or infant are unknown.
As mentioned previously, this injection is administered in the eye through the sclera (the white part of the eye) into the vitreous cavity. A patient arrives at the eye center as scheduled. We take the patient into the operating theater, where the injection procedure involves cleaning the entire half of the face on the side where the injection is planned. After covering the eye with drapes, we administer the injection under strict aseptic conditions. Eylea comes in a single-use glass vial and is aspirated into a tuberculin syringe, which is a thin syringe capable of injecting about 1 ml of medication. A 30G needle is then used to inject 0.05 ml of the drug into the eye. If your ophthalmologist notices an increase in eye pressure after the injection, they may take steps to reduce it immediately. The most important thing to remember is that aseptic injection technique should be used.
The eye is patched immediately after the injection. The patient can go home right away, and the patch is removed after 2 hours. Your ophthalmologist will prescribe certain eye drops, which are usually antibiotics to be used for a week. We also advise patients not to take a head bath for 2 days after the injection.
As with any intraocular injection, there are some risks. The most commonly reported adverse reactions (>10%) are listed below.
Typically, after the injection, you might experience:
Severe complications are rare and include:
The benefits of this injection are not visible immediately. As the macular edema reduces, central vision gradually improves. The response to treatment may take 2-3 weeks, and sometimes even a month. However, an effect is often seen within the first few weeks. We usually call patients back within the first 5 days to ensure there have been no adverse effects. Following this, the patient is seen at 1 month to recheck vision and repeat an OCT scan, which will tell us exactly how much the retinal swelling has reduced. Further injections are then planned based on the dosing schedule the patient is on.
We still do not have enough information to determine how many injections can be taken. However, the goal of treatment is to keep the patient on the minimum number of injections that can still provide maximum results.
EYLEA HD is Aflibercept Injection 8 mg in 0.07 mL, which is a higher dose than the standard Eylea. In August 2023, the USFDA approved Eylea HD for the treatment of Wet Age-related Macular Degeneration (wAMD), Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR).
The recommended dose for EYLEA HD is 8 mg (0.07 mL of 114.3 mg/mL solution) every 4 weeks (monthly) for the first 3 months across all indications, followed by 8 mg every 8 to 16 weeks (2 to 4 months) for wAMD and DME, and every 8 to 12 weeks (2 to 3 months) for DR. With EYLEA HD, patients with these retinal diseases can now receive less frequent injections after their initial monthly doses and still experience similar visual gains, anatomic improvements, and the safety profile of EYLEA.
In the clinical trials, patients treated with EYLEA HD demonstrated non-inferior and clinically equivalent vision gains at 48 weeks with both 12- and 16-week dosing regimens after only 3 initial monthly doses, compared to an EYLEA 8-week dosing regimen after the initial monthly doses. The vast majority of patients randomized at baseline to EYLEA HD 12- or 16-week dosing regimens (following 3 initial monthly doses) were able to maintain these dosing intervals through 48 weeks.
Eylea HD is not yet available in India.
HI