FDA expands indication for Eylea to cover all stages of diabetic retinopathy

pharmafile | May 14, 2019 | News story | Manufacturing and Production Bayer, Eylea, FDA, Regeneron, approval, pharma 

The FDA has expanded the indication for Regeneron’s Eylea (aflibercept) to include all stages of diabetic retinopathy.

Regeneron chief scientific officer George Yancopoulos commented: “with today’s FDA approval, Eylea has once again set a high bar for the treatment of diabetic eye diseases.”

The approval was backed by data from the Phase 3 PANORAMA trial of 402 patients. The study found 80% of patients who received the drug every eight weeks experienced an at least 2-step improvement in the Diabetic Retinopathy Severity Scale score versus baseline, compared with 15 percent for placebo.  

Eylea was first approved in the US for the treatment of wet age-related macular degeneration in 2011.  

The drug is now being studied as a cancer treatment and being co-developed by Bayer and Regeneron for eye diseases.

Louis Goss

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