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Regeneron Reports Full Year and Fourth Quarter 2010 Financial and Operating Results
Date:2/17/2011

;The most common adverse events were those typically associated with intravitreal injections or the underlying disease.  Serious ocular adverse events in the VEGF Trap-Eye group were uncommon (3.5%) and were more frequent in the control group (13.5%).  The incidence of non-ocular serious adverse events was generally well-balanced between the treatment arms.  

Initial results from GALILEO, the second of the two Phase 3 studies in CRVO, are expected in the first half of 2011.

Phase 2 study in diabetic macular edema

In December 2010, Regeneron and Bayer Healthcare reported 52-week results from a Phase 2 study (DA VINCI) comparing treatment with VEGF Trap-Eye to focal laser therapy, the current standard of care, in patients with clinically significant diabetic macular edema (DME).  The DME data showed that previously reported visual acuity gains achieved with VEGF Trap-Eye treatment over 24 weeks, the primary endpoint of the study, were maintained or numerically improved up to completion of the study at week 52 in all VEGF Trap-Eye study groups, including the group receiving a 2.0 mg dose every other month.  At week 52, all VEGF Trap-Eye dose groups reported mean gains in visual acuity of 9.7 to 13.1 letters, compared to a mean loss of 1.3 letters for patients receiving focal laser therapy (p<0.01 for each VEGF Trap-Eye group versus focal laser).

In DA VINCI, VEGF Trap-Eye was generally well tolerated.  The most common adverse events reported were those typically associated with intravitreal injections or the underlying disease.  The most frequent ocular adverse events reported among patients receiving VEGF Trap-Eye included conjunctival hemorrhage, eye pain, ocular redness (hyperemia), and increased intraocular pressure.  There were no non-ocular serious adverse events judged by investigators to be drug-related during the first six months of the study and one during the second six months.  '/>"/>

SOURCE Regeneron Pharmaceuticals, Inc.
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