Regeneron Pharmaceuticals has received marketing approval for their eye drug - Eylea, an injection meant to treat a common cause of blindness in older people. Eylea can be used to treat “wet” age-related macular degeneration. The only other drug approved for the condition is Lucentis from Roche, which was approved in 2006.
The Food and Drug Administration approved Eylea for wet age-related macular degeneration, a leading cause of vision loss in people 60 and older, the company said in a statement today. The drug will hit peak sales of $1.1 billion in 2021 as its use is expanded to other eye disorders, said Yaron Werber, an analyst for Citigroup Inc. in New York. The FDA initially delayed its decision on Aug. 16 saying that answers Regeneron provided to the agency on its application about manufacturing controls were “a major amendment.”
The company spokesperson said Eylea can be injected every eight weeks, half as often as Lucentis. Less frequent dosing may help Eylea capture 16 percent of the U.S. market from Lucentis, Werber said in a telephone interview before the approval was announced. “We think doctors want to experiment with the drug and there’s a lot of interest,” he said. “Cost is very important and we think it’s going to be priced at parity with Lucentis per injection but fewer injections per year.” Werber anticipates Eylea may cost $1,950 an injection. Lucentis is $2,000 for each monthly injection.
Age-related macular degeneration is a breakdown of the eye’s macula, the part of the eye that allows people to see fine detail needed to do tasks such as reading and driving. In the wet form of the disease, there is abnormal growth of blood vessels that can leak fluid into the macula, leading to vision loss. Regeneron estimates about 1.5 million people have the wet form of the disease with 200,000 new cases diagnosed each year.
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