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FDA approves Eylea to treat diabetic retinopathy in patients with diabetic macular edema
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The FDA has approved Eylea injection to treat diabetic retinopathy in diabetic macular edema patients, according to an agency press release.
Two clinical studies evaluated the safety and efficacy of Eylea (aflibercept, Regeneron) vs. macular laser photocoagulation in 679 patients, with results showing significant improvement in the severity of diabetic retinopathy at 100 weeks after Eylea injection compared with laser, the release said.
Eylea is also approved to treat wet age-related macular degeneration, DME and macular edema secondary to retinal vein occlusions. It had previously received breakthrough therapy designation to treat diabetic retinopathy in DME.
The FDA reviewed this new use of Eylea under its 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,” the release said.