Regeneron (REGN) Says EYLEA Clinically Equivalent to Lucentis Following VIEW 1, 2 Phase 3s

October 18, 2012 4:25 PM EDT
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that detailed one-year results from the VIEW 1 and VIEW 2 Phase 3 studies of EYLEA (aflibercept) Injection were published online in the journal Ophthalmology ahead of a future print publication. The publication can be accessed at http://digitalreprints.elsevier.com/t/28599.

"The article published today provides additional details about the VIEW 1 and VIEW 2 studies that demonstrated that EYLEA offered similar improvements in visual acuity to monthly ranibizumab, but with less frequent dosing," stated George D. Yancopoulos, M.D., Ph.D., Chief Scientific Officer of Regeneron and President of Regeneron Laboratories. "This message has resonated both with physicians and patients since the launch of EYLEA in November 2011. We are happy to be able to offer another treatment option to patients suffering from wet AMD, the most common cause of blindness in the U.S. among older adults."

EYLEA, for the treatment of patients with neovascular (wet) age-related Macular Degeneration (wet AMD) was granted a Priority Review by the U.S. Food and Drug Administration (FDA), a designation that is given to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists, and approved in November 2011. The approval was based upon the results of two Phase 3 clinical studies, VIEW 1 and VIEW 2, published today in the journal Ophthalmology. In these studies, EYLEA dosed every eight weeks, following three initial monthly injections, was shown to be clinically equivalent to Lucentis® (ranibizumab injection) dosed every four weeks, as measured by the primary endpoint of maintenance of best-corrected visual acuity (less than 15 letters of vision loss on an eye chart as measured on an ETDRS scale) over 52 weeks.

EYLEA is contraindicated in patients with ocular or periocular infections, active intraocular inflammation, or known hypersensitivity to aflibercept or to any of the excipients in EYLEA.

The most common adverse reactions (frequency of 5% or more) reported in wet AMD patients receiving EYLEA were conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and increased intraocular pressure.


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