Aflibercept, a vascular endothelial growth factor (VEGF) inhibitor administered by intravitreal injection, is now approved for treating diabetic retinopathy in patients with diabetic macular edema (DME), the Food and Drug Administration announced on March 25.
Aflibercept was previously approved for treating wet (neovascular) age-related macular degeneration, and for treating DME and macular edema secondary to retinal vein occlusions, “both of which cause fluid to leak into the macula resulting in blurred vision,” according to the FDA statement announcing approval. The first five injections of aflibercept are administered once a month, followed by one injection every 2 months. Aflibercept is marketed as Eylea by Regeneron Pharmaceuticals; it was initially approved in 2011.
“Today’s approval gives patients with diabetic retinopathy and diabetic macular edema another therapy to treat this vision-impairing complication,” Dr. Edward Cox, director of the office of antimicrobial products in the FDA’s Center for Drug Evaluation and Research, said in the statement. In February, the FDA approved ranibizumab ( Lucentis ), another VEGF inhibitor, for the same indication.
Approval of aflibercept was based on two phase III studies of 679 patients with diabetic retinopathy and DME, who were randomized to treatment with aflibercept or macular laser photocoagulation. At 2 years, those treated with aflibercept “showed significant improvement in the severity of their diabetic retinopathy, compared to patients who did not receive Eylea,” according to the FDA statement. Conjunctival hemorrhage, eye pain, cataracts, vitreous floaters, increased intraocular pressure, and vitreous detachment were among the most common adverse events (reported by at least 5% of treated patients) associated with treatment. Endophthalmitis and retinal detachments were among the serious adverse events associated with treatment.
The two studies are the VISTA-DME and VIVID-DME trials, according to the Regeneron statement announcing approval.
Adverse events associated with aflibercept should be reported to the FDA’s MedWatch program at 800-332-1088 or www.fda.gov/medwatch.
