FDA Expands Approval of Regeneron’s Eylea for Diabetic Retinopathy in Patients with Diabetic Macular Edema

The US Food and Drug Administration (FDA) has expanded approval of Regeneron’s macular degeneration drug for treatment of diabetic retinopathy in patients with diabetic macular edema (DME).

The agency’s approval of Regeneron Pharmaceuticals’ Eylea (afilibercept) injection for treatment of diabetic retinopathy (DR) in patients with DME marks the fourth approval for the injectable drug which generated US annual revenues of roughly $1.7 billion in 2014.

DR is the most common diabetic eye disease and is the leading cause of blindness in adults in the US. According to the FDA, in 2008, 33 percent 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. If the new blood vessels break, severe vision loss or blindness can occur.

“Diabetic retinopathy coupled with DME is a serious complication of diabetes that can threaten the vision of many working-age adults,” said George D. Yancopoulos, MD, PhD, Chief Scientific Officer of Regeneron Laboratories. “In addition to improving visual acuity in people with DME, Eylea also improves these patients’ retinal vessel damage, or retinopathy. Eylea is the only treatment option for diabetic retinopathy in patients with DME that is approved for less than monthly dosing after an initial monthly dosing period.”

The recommended dosage of Eylea is 2 mg every two months after five initial monthly injections.

The agency’s expanded approval is based on results from two clinical studies, where participants were randomly assigned to receive Eylea or macular laser photocoagulation, a laser-based treatment used to burn small areas of the retina. At week 100, participants receiving Eylea demonstrated significant improvement in the severity of their DR compared to patients who did not receive Eylea. The most common side effects associated with the drug include bleeding of the conjunctiva, eye pain, cataracts, floaters, increased pressure inside the eye, and separation of the interior jelly of the eye from the retina. Serious adverse reactions include infection within the eye and retinal detachments.

Eylea is now the second drug approved this year to treat DR in patients with DME. In February, the FDA approved Genentech’s Lucentis (ranibizumab) for this patient population.

The US FDA granted Eylea Breakthrough Therapy designation and Priority Review for the treatment of DR in patients with DME. The drug was already approved for treatment of wet age-related macular degeneration (AMD), DME and macular edema secondary to retinal vein occlusions.

Sources: Regeneron Pharmaceuticals, Inc.; US Food and Drug Administration

Last updated: 3/25/15; 1:35pm EST

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