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US FDA rejects Regeneron application to change eye drug's dosing schedule

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US FDA rejects Regeneron application to change eye drug's dosing schedule

Regeneron Pharmaceuticals Inc. said the U.S. Food and Drug Administration rejected its application to change the dosing schedule of its eye drug Eylea to 12 weeks.

Eylea is approved in the U.S. for treating wet age-related macular degeneration, or AMD, in four- or eight-week dosing intervals following three initial monthly doses.

Wet AMD is caused by the growth of abnormal blood vessels that leak fluid or blood into the macula, a part of the retina, leading to blurred vision or total vision loss.

The company received a complete response letter from the U.S. FDA for the application, which was accepted for review in December 2017.

The Tarrytown, N.Y.-based drugmaker said it expects to complete discussions with the FDA and receive a final decision in about two months.