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

total number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart, a standard chart used in research to measure visual acuity.  Maintenance of vision was defined as losing fewer than three lines (equivalent to 15 letters) on the ETDRS eye chart.

In VIEW 1 and VIEW 2, a generally favorable safety profile was observed for both VEGF Trap-Eye and ranibizumab.  The incidence of ocular treatment emergent adverse events was balanced across all four treatment groups in both studies, with the most frequent events associated with the injection procedure, the underlying disease, and/or the aging process.  The most frequent ocular adverse events were conjunctival hemorrhage, macular degeneration, eye pain, retinal hemorrhage, and vitreous floaters.  The most frequent serious non-ocular adverse events were typical of those reported in this elderly population who receive intravitreal treatment for wet AMD.

Phase 3 studies in central retinal vein occlusion

In December 2010, Regeneron and Bayer Healthcare reported positive initial results from the COPERNICUS study, the first of two Phase 3 studies evaluating VEGF Trap-Eye in central retinal vein occlusion (CRVO).  Patients received six monthly intravitreal injections of either VEGF Trap-Eye at a dose of 2.0 milligrams (mg) or sham control injections.  In COPERNICUS, VEGF Trap-Eye met the primary endpoint of a statistically significant improvement in vision at six months compared to sham injections.  In this trial, 56.1% of patients receiving VEGF Trap-Eye gained at least 15 letters of vision from baseline, compared to 12.3% of patients receiving sham injections (p<0.0001).  Patients receiving VEGF Trap-Eye on average gained 17.3 letters of vision, compared to a mean loss of 4.0 letters with sham injections (p<0.001), a secondary endpoint.  

In the COPERNICUS study, VEGF Trap-Eye was generally well tolerated.  
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SOURCE Regeneron Pharmaceuticals, Inc.
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Related medicine technology :

1. Bayer and Regeneron Dose First Patient in Second Phase 3 Study for VEGF Trap-Eye in Wet Age-Related Macular Degeneration
2. Bayer and Regeneron Extend Development Program for VEGF Trap-Eye to Include Central Retinal Vein Occlusion
3. Enrollment Completed in Regeneron and Bayer HealthCare Phase 3 Studies of VEGF Trap-Eye in Neovascular Age-Related Macular Degeneration (Wet AMD)
4. Regeneron Announces Presentation at the 18th Annual Credit Suisse Healthcare Conference
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6. Sanofi-aventis and Regeneron Expand Strategic Antibody Collaboration
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8. BioMed Realty Trust Signs New Lease With Regeneron Pharmaceuticals for 131,000 Square Feet at Landmark
9. Regeneron Announces Presentation at the Morgan Stanley Global Healthcare Conference
10. Regeneron Announces Presentation at the UBS Global Life Sciences Conference
11. Regeneron Announces Panel Discussion at Citis 5th Annual Biotech Day
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