EYLEA Receives FDA Breakthrough Therapy Designation

Regeneron Pharmaceuticals announced on Sept. 16, 2014 that FDA has granted EYLEA Injection Breakthrough Therapy designation for the treatment of diabetic retinopathy in patients with diabetic macular edema (DME). EYLEA is approved in the United States, European Union, and other countries for the treatment of wet age-related macular degeneration (AMD), macular edema following central retinal vein occlusion (CRVO), and DME. Regulatory submissions have been made for EYLEA in the US and EU for macular edema following branch retinal vein occlusion (BRVO).

In the Phase 3 VIVID-DME trial in diabetic retinopathy patients with DME, 29% of evaluable patients in the 2Q4 group (monthly) and 33% of evaluable patients in the 2Q8 group (every two months, after five initial monthly injections) treated with EYLEA experienced at least a two-step improvement on the diabetic retinopathy severity scale (DRSS), a grading system measuring the degree of retinopathy, compared to 8% of patients in the laser control group (p less than 0.001), according to the company. In the Phase 3 VISTA-DME trial in diabetic retinopathy patients with DME, 40% of evaluable patients in both the 2Q4 and 2Q8 groups treated with EYLEA experienced at least a two-step improvement on the DRSS compared to 17% of patients in the laser control group (p less than 0.0001).