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Regeneron and Bayer Report Positive Results for VEGF Trap-Eye in Phase 3 Study in Central Retinal Vein Occlusion (CRVO) and in Phase 2 Study in Diabetic Macular Edema (DME)
Date:12/20/2010

ized and 219 patients were treated with balanced distribution over five groups.  The control group received macular laser therapy at baseline, and patients were eligible for repeat laser treatments, but no more frequently than at 16 week intervals.  Two groups received monthly doses of 0.5 or 2mg of VEGF Trap-Eye throughout the 12-month dosing period.  Two groups received three initial monthly doses of 2mg of VEGF Trap-Eye (at baseline and weeks 4 and 8), followed through week 52 by either every two months dosing or PRN (as-needed) dosing with very strict repeat dosing criteria. Mean gains in visual acuity versus baseline were as follows:Laser

0.5mg

monthly

2mg

monthly

2mg

every two

months*

2mg

PRN*n

44

44

44

42

45Mean change in visual acuity at week 24 versus baseline(1) (letters)

2.5

8.6**

11.4**

8.5**

10.3**Mean change in visual acuity at week 52 versus baseline (letters)

-1.3

11.0**

13.1**

9.7**

12.0***Following 3 initial monthly doses

**p<0.01 versus laser

(1) Primary endpointNo significant differences among the VEGF Trap-Eye arms were observed.  Approximately 80 percent of the VEGF Trap-Eye patients and 75 percent of the laser patients remained in the study through 52 weeks.

VEGF Trap-Eye was generally well-tolerated, and there were no ocular or non-ocular drug-related serious adverse events reported in the study.  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.  The incidence of non-ocular serious adverse events was generally well balanced between all treatment arms. 
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SOURCE Regeneron Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
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