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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