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FDA approves EYLEA injection

Monday, November 21, 2011 09:27 AM

The FDA has approved Regeneron Pharmaceuticals' EYLEA (aflibercept) injection for the treatment of patients with neovascular (wet) Age-related Macular Degeneration (AMD) at a recommended dose of 2 milligrams (mg) every four weeks (monthly) for the first 12 weeks, followed by 2 mg every eight weeks (2 months).

The approval of EYLEA was granted under a Priority Review, a designation that is given to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists. This approval was based upon the results of two phase III clinical studies. In these studies, EYLEA dosed every eight weeks, following three initial monthly injections, was clinically equivalent to the standard of care, Lucentis (ranibizumab injection) dosed every four weeks, as measured by the primary endpoint of maintenance of visual acuity (less than 15 letters of vision loss on an eye chart) over 52 weeks.  The most common adverse reactions (frequency of 5% or more) reported in patients receiving EYLEA were conjunctival
hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and increased intraocular pressure. The adverse event profile was similar to that seen with ranibizumab.

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