Regeneron : FDA Oks New Treatment For Diabetic Retinopathy In Patients With DMS

(RTTNews) - Regeneron Pharmaceuticals Inc. (REGN) announced that the U.S. Food and Drug Administration or FDA has approved EYLEA or aflibercept Injection for the treatment of diabetic retinopathy in patients with diabetic macular edema or DME.

In 2014, the FDA granted EYLEA Breakthrough Therapy designation and Priority Review for the treatment of diabetic retinopathy in patients with DME.

The recommended dosage of EYLEA in patients with diabetic retinopathy in DME is 2 milligrams (mg) every two months (8 weeks) after five initial monthly injections. Although EYLEA may be dosed as frequently as 2 mg every 4 weeks, additional efficacy was not demonstrated when EYLEA was dosed every 4 weeks compared to every 8 weeks.

EYLEA is available as a single, 2 milligram (mg) strength intravitreal injection for all approved indications. EYLEA was previously approved in the U.S. for the treatment of wet age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), and diabetic macular edema.

Diabetic retinopathy is a common complication of diabetes, causing damage to the retina, which may lead to poor vision and vision loss. Over time, patients with diabetic retinopathy are at risk of experiencing vision-threatening events.

These include DME, which refers to swelling of the macula (the part of the retina responsible for central, fine vision) and progression to proliferative diabetic retinopathy, which often results in profound visual loss due to complications including vitreous hemorrhage and/or tractional retinal detachment. DME is the most frequent cause of vision loss in patients with diabetes and eventually can lead to blindness.