(RxWiki News) There's a new, FDA-approved treatment for diabetic retinopathy.
The US Food and Drug Administration (FDA) today approved Eylea (aflibercept) to treat diabetic retinopathy in diabetic macular edema patients.
“Diabetes is a serious public health crisis, affecting more patients every year,” said Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, in a press release. “Today’s approval gives patients with diabetic retinopathy and diabetic macular edema another therapy to treat this vision-impairing complication.”
Diabetic retinopathy is an eye disease common to diabetes patients that can cause blindness. In fact, it's the leading cause of blindness among US adults, according to the FDA.
Eylea is given as a once-monthly injection into the eye. Chris Johnson, RPh, owner of MedSavers Pharmacy in Austin, TX, told dailyRx News that Eylea would likely be pretty pricey.
"Cash price for Eylea is approximately $1850 per month for the first 3 months of therapy," Johnson said. "The price will drop to $1850 every other month thereafter as the frequency of dosing goes down at that point. The other selective vascular endothelial growth factor antagonist on the market is Lucentis, which runs between $1170 and $1950 per month for the first 3 months.
"Both have significant reporting of conjunctival hemorrhage, though Eylea shows significantly less than Lucentis compared to placebo."
Two clinical studies assessed the safety and effectiveness of Eylea in the treatment of diabetic retinopathy. These trials found that Eylea may reduce the severity of diabetic retinopathy compared to an alternative, laser-based treatment.
These trials also found some side effects of the Regeneron Pharmaceuticals drug. These included bleeding of the tissues near the eyes (conjunctival hemorrhage), eye pain, increased eye pressure, cataracts and floaters. Serious side effects included eye infections and retinal detachment, in which the retina pulls away from the blood vessels that bring it oxygen and nutrients.
Eylea was previously approved to treat age-related macular degeneration.
"These are important drugs in the arsenal for fighting diabetic retinopathy," Johnson said. "The biggest hurdle is cost. If it's covered on one's insurance, great. If not, or if a patient simply doesn't have insurance, the out-of-pocket expense for most will be impossible unless they can navigate each company's patient assistance programs."
