U.S. Food and Drug Administration today expanded the approved use for Eylea (aflibercept) injection to treat diabetic retinopathy in patients with diabetic macular edema. Diabetic retinopathy (DR) is the most common diabetic eye disease and is a leading cause of blindness in adults in the United States. According to the Centers for Disease Control and Prevention, diabetes (type 1 and type 2) affects more than 29 million people in the United States and is the leading cause of new blindness among people ages 20 to 74 years.
In 2008, 33
percent of adults with diabetes aged 40 years or older had some form of
DR. In some cases of DR with diabetic macular edema (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.
“Diabetes is a
serious public health crisis, affecting more patients every year,” said
Edward Cox, M.D., M.P.H, director of the Office of Antimicrobial
Products in the FDA’s Center for Drug Evaluation and Research. “Today’s
approval gives patients with diabetic retinopathy and diabetic macular
edema another therapy to treat this vision-impairing complication.”
In February, the FDA approved Lucentis (ranibizumab injection) 0.3 mg to treat DR in patients with DME.
is administered by a physician as an injection into the eye once a
month for the first five injections and then once every two months. It
is intended to be used along with appropriate interventions to control
blood sugar, blood pressure and cholesterol.
The safety and
efficacy of Eylea to treat DR in patients with DME were evaluated in 679
participants in 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 being treated with Eylea showed significant
improvement in the severity of their DR, compared to patients who did
not receive Eylea.
The most common side effects associated with
Eylea include bleeding of the conjunctiva (the tissue that lines the
inside of the eyelids and covers the white part of the eye); eye pain;
cataracts; floaters; increased pressure inside the eye (increased
intraocular pressure); and separation of the interior jelly of the eye
from the retina (vitreous detachment). Serious adverse reactions include
infection within the eye (endophthalmitis) and retinal detachments.
FDA granted breakthrough therapy designation to Eylea for the treatment
of DR with DME. The FDA can designate a drug a breakthrough therapy at
the request of the sponsor if preliminary clinical evidence indicates
the drug may demonstrate a substantial improvement over available
therapies for patients with serious or life-threatening conditions. The
FDA also reviewed the new use for Eylea under the agency’s priority
review program, which provides for an expedited review of drugs that
demonstrate the potential to be a significant improvement in safety or
effectiveness in the treatment of a serious condition.
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.
marketed by Tarrytown, N.Y.-based Regeneron Pharmaceuticals Inc.
Lucentis is marketed by South San Francisco, California-based Genentech,
a subsidiary of Roche Pharmaceuticals.
The FDA, an agency within
the U.S. Department of Health and Human Services, promotes and protects
the public health by, among other things, assuring the safety,
effectiveness, and security of human and veterinary drugs, vaccines and
other biological products for human use, and medical devices. The agency
also is responsible for the safety and security of our nation’s food
supply, cosmetics, dietary supplements, products that give off
electronic radiation, and for regulating tobacco products.