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FDA Approves an Eye Drug for Diabetic Patients

Sep 25, 2014

The U.S. Food and Drug Administration has approved the use of Eylea (aflibercept) which may improve vision for patients with diabetes….



Diabetic patients are at higher risk for diabetic macular edema (DME) which can cause damage to the retina and can lead to vision loss or blindness. DME is the most common cause of vision loss in diabetic patients. Regeneron Pharmaceuticals, Inc has announced that FDA has designated Eyela (aflibercept), an injectable drug for eye diseases, as a breakthrough therapy to treat diabetic retinopathy in patients with macular edema. Eylea, a vascular endothelial growth factor inhibitor, is an injection administered into the eye.

The decision was made based on two phase 3 clinical trials. These trials included 862 patients and compared Eylea 2 mg given every month, given every two months after five initial monthly injection, and macular laser photocoagulation. In both trials, Eylea demonstrated a significant improvement in diabetic retinopathy in patients with DME after two years of treatment.

Both trials showed 2-step improvement on the diabetic retinopathy severity scale (DRSS) compared to patients in the placebo group (P <0.001 and P<0.0001). The most common side effects that were observed were conjunctival hemorrhage, eye pain, cataract, and vitreous floaters.
In U.S., Eylea is approved for the treatment of DME, wet age-related macular degeneration (AMD), and macular edema following central retinal vein occlusion (CRVO).

Practice Pearls:

  • Eylea (aflibercept) is approved for DME, AMD, and CRVO.
  • Two phase 3 clinical trials showed 2 steps improvement in retinopathy in patients who tool Eylea on DRSS scale.
  • The recommended dose for Eylea 2mg, starting with 5 initial monthly dose and then given every 2 months.

"EYLEA® (aflibercept) Injection Receives FDA Approval for the Treatment of Diabetic Macular Edema (DME)." Regenneron Pharmaceuticals, Inc, 29 July 2014. Web. <http://files.shareholder.com/downloads/REGN/3491231732x0x772028/698a12f7-a8dc-4f89-b9e2-f8134ae6f3de/REGN_News_2014_7_29_General_Releases.pdf>.