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Regeneron Submits Biologics License Application to FDA for VEGF Trap-Eye for Treatment of Wet Age-Related Macular Degeneration
Date:2/22/2011

vents were falls, pneumonia, myocardial infarction, atrial fibrillation, breast cancer, and acute coronary syndrome.  There were no notable differences among the study arms.

As-needed (PRN) dosing with both agents, with a dose administered at least every three months (but not more often than monthly), is being evaluated during the second year of VIEW 1 and VIEW 2.  These studies are part of the global development program for VEGF Trap-Eye being conducted by Regeneron and Bayer HealthCare.

About VEGF Trap-EyeVEGF Trap-Eye is a fusion protein consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 that binds all forms of VEGF-A, along with the related Placental Growth Factor (PlGF).  VEGF Trap-Eye is a specific and highly potent blocker of these growth factors.  VEGF Trap-Eye is specially purified and contains iso-osmotic buffer concentrations, allowing for injection into the eye.

Regeneron and Bayer HealthCare are collaborating on the development of VEGF Trap-Eye for the treatment of wet AMD, central retinal vein occlusion, diabetic macular edema, myopic choroidal neovascularisation, and other eye diseases and disorders.  Bayer HealthCare intends to submit regulatory applications in the first half of 2011 for marketing approval in Europe.  If approved by regulatory authorities, Bayer HealthCare will market VEGF Trap-Eye outside the United States, where the companies will share equally in profits from any future sales of VEGF Trap-Eye.  Regeneron maintains exclusive rights to VEGF Trap-Eye in the United States.

About Wet Age-Related Macular Degeneration (wet AMD)Age-related macular degeneration (AMD) is a leading cause of acquired blindness.  Macular degeneration is diagnosed as either dry (non-exudative) or wet (exudative).  In wet AMD, new blood vessels grow beneath the retina and leak blood and fluid.  This leakage causes di
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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
5. Regeneron Reports Third Quarter 2009 Financial and Operating Results
6. Sanofi-aventis and Regeneron Expand Strategic Antibody Collaboration
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