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FDA Again Expands Use of Eye Drug Eylea (Aflibercept)

Treatment now approved for retinopathy in patients with diabetic macular edema

The FDA has expanded the approved uses of Eylea (aflibercept, Regeneron Pharmaceuticals) injection to include the treatment of diabetic retinopathy (DR) in patients with diabetic macular edema (DME).

According to the Centers for Disease Control and Prevention, diabetes (type-1 and type-2) affects more than 29 million people in the U.S. and is the leading cause of new blindness among people aged 20 to 74 years. In 2008, 33% of adults with diabetes aged 40 years or older had some form of DR. In some cases of DR with DME, abnormal new blood vessels grow on the surface of the retina. Severe vision loss or blindness can occur if the new blood vessels break.

In February, the FDA approved a competing drug, Lucentis (ranibizumab injection, Genentech/Roche), to treat DR in patients with DME.

Eylea is administered by a physician as an injection into the eye once a month for the first five injections and then once every 2 months. It is intended to be used along with appropriate interventions to control blood sugar, blood pressure, and cholesterol.

The safety and efficacy of aflibercept in DR in patients with DME were evaluated in 679 participants in two clinical studies, in which the participants were randomly assigned to receive aflibercept or macular laser photocoagulation (a laser-based treatment used to burn small areas of the retina). At week 100, patients treated with aflibercept showed significant improvement in the severity of their DR compared with patients who did not receive aflibercept.

The most common adverse effects associated with aflibercept included bleeding of the conjunctiva, eye pain, cataracts, “floaters,” increased intraocular pressure, and vitreous detachment. Serious adverse reactions included endophthalmitis and retinal detachments.

The FDA granted a “breakthrough therapy” designation to Eylea for the treatment of DR with DME. The agency also evaluated the new use for Eylea under its priority review program, which allows an expedited review of drugs that demonstrate the potential to offer a significant improvement in safety or efficacy in the treatment of a serious condition.

The FDA previously approved Eylea to treat wet (neovascular) age-related macular degeneration, a condition in which abnormal blood vessels grow and leak fluid into the macula. Eylea is also approved to treat DME and macular edema secondary to retinal-vein occlusions, both of which cause fluid to leak into the macula, resulting in blurred vision.

Source: FDA; March 25, 2015.

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