What Is Eylea, and Why Does It Matter?
Eylea HD (aflibercept) is an injectable prescription medicine used for treating certain eye conditions that can cause vision loss over time.
The FDA has now approved the extended dosing of Eyela HD (8 milligrams) to once every 20 weeks (about five months) in some patients with wet age-related macular degeneration (wAMD) or diabetic macular edema (DME) who have shown good clinical results after a year of treatment. Previously, the standard regimen used a 2-milligram dose given about every eight weeks after initial monthly doses. Depending on clinical criteria, the Eyela HD dosing schedule can be tailored from about once every four weeks in those requiring frequent treatment to as infrequently as once every 20 weeks for those who respond well.
wAMD is an age-related condition affecting the retina of the eye. It is caused by the growth of abnormal blood vessels under the macula (the part of the eye responsible for sharp central vision) and leak fluid, leading to macular damage and loss of vision. Diabetic retinopathy (DR) is a complication of poorly controlled diabetes in which high blood sugar levels damage the small blood vessels in the retina. It often begins without symptoms (nonproliferative DR) but can progress to a more severe stage (proliferative DR) in which abnormal blood vessels grow on the surface of the retina, leading to significant vision loss. DME can develop during any stage of DR as the fragile blood vessels leak fluid into the macula, leading to swelling and vision impairment. In the U.S., about 1.4 million people are affected by wAMD, about 1.5 million adults have DME, and roughly 6 million have DR without DME.
Eylea HD is a vascular endothelial growth factor (VEGF) inhibitor. VEGF-A and placental growth factor (PlGF) proteins bind with their receptors, triggering the formation of abnormal blood vessels and make existing vessels leak. Eyela HD acts as a decoy receptor for VEGF-A and PIGF proteins, blocking their signals that drive the formation of weak, leaky blood vessels in the retina, which can harm vision.
Eyela HD is also approved to treat DR and macular edema following retinal vein occlusion (RVO). This approval is important because according to the manufacturing company, it introduces a wider dosing range than that used with other injectable anti-VEGF therapies. The extended dosing schedule may allow for fewer injections and clinic visits for some patients, depending on clinical assessments and individual response to therapy.
Why Was It Approved?
The FDA approval is based on results from 96-week-long clinical studies that showed that a majority of patients treated with Eyela HD maintained their vision and eye anatomy outcomes even with longer gaps between doses. The Eyela HD label has been updated to include the findings from the latest 96-week clinical study data.
In the studies, through 48 weeks, Eylea HD given every 12 or 16 weeks worked as well as Eylea 2 milligrams given every eight weeks as per changes on a standard vision test called best-corrected visual acuity (BCVA).
Durability was a key finding. Among patients with wAMD, 71% of patients achieved a dosing interval of at least 16 weeks, and 47% of patients achieved 20 weeks or longer by week 96 while maintaining their vision and anatomical outcomes.
Among patients with DME, 72% of patients achieved 16-week dosing intervals and 44% of patients achieved 20-week intervals while maintaining their clinical outcomes.
Safety findings were consistent with those for intravitreal anti-VEGF therapy. Common side effects included cataract, small bleeds on the eye surface, a scratch on the cornea, higher eye pressure, eye discomfort or pain or irritation, retinal bleeding, blurry vision, vitreous detachment, and floaters.
Serious eye problems can occur after an injection, such as an infection inside the eye (endophthalmitis), separation of the retina from back of the eye (retinal detachment), or retinal vasculitis, which can happen with or without a blockage. Eye pressure can rise for a short time within about an hour after the shot. A potential risk for artery-related clots, like stroke or heart attack, is also present with VEGF inhibitors.
What Do I Need to Know?
Eylea HD is given as an injection into the eye by a trained eye care professional.
For wAMD and DME, you usually start with monthly injections for the first three doses. After that, dosing often moves to once every eight to 16 weeks. If you keep doing well for a year, your eye doctor may extend the dosing interval to once every 20 weeks, following the updated label criteria.
For DR, after the initial three monthly doses, the injection is given once every eight to 12 weeks.
For macular edema, you receive three to five monthly doses after RVO followed by treatment every eight weeks.
If you are unable to maintain your clinical response on longer dosing intervals or if there is evidence of worsening of disease, your eye doctor might recommend you return to the once-every-four-weeks dosing.
Do not receive Eylea HD if you have an infection in your eye or near the eyelid area, active inflammation inside the eye, or a known allergy to Eyela or any of its ingredients.
After an injection, watch for eye pain, redness, light sensitivity, or sudden vision changes, and get care right away if these occur. Do not drive or use machinery until your vision clears after the visit. Your eye doctor might monitor you after each injection for any signs of increased eye pressure.
Be sure to tell your eye doctor if you are pregnant, planning to get pregnant, or breastfeeding as Eylea HD may harm a fetus. However, it is not known whether Eylea HD passes into breast milk or affects it in any way.