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

Published on 14/05/19 at 11:01am

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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