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Bayer and Regeneron Dose First Patient in Second Phase 3 Study for VEGF Trap-Eye in Wet Age-Related Macular Degeneration
Date:5/7/2008

International Study to Evaluate Efficacy and Safety in Treating a Leading

Cause of Blindness

LEVERKUSEN, Germany, MONTVILLE, New Jersey and TARRYTOWN, New York, May 8 /PRNewswire-FirstCall/ -- Bayer HealthCare AG and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the first patient has been dosed in the VIEW 2 trial, a second Phase 3 clinical study in a development program evaluating VEGF Trap-Eye for the treatment of the neovascular form of Age-related Macular Degeneration (wet AMD), a leading cause of blindness in adults.

VIEW 2 (VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD) will enroll approximately 1,200 patients in up to 200 centers in Europe, Asia Pacific, Japan and Latin America. The first Phase 3 trial, VIEW 1, began enrolling patients in August 2007 in the United States and Canada. Both VIEW 1 and VIEW 2 are designed to evaluate the efficacy and safety of VEGF Trap-Eye administered by intravitreal injection, at dosing intervals of 4 and 8 weeks. The development program will include visual acuity endpoints and anatomical endpoints, including retinal thickness, a measure of disease activity. The trial is intended to establish non-inferiority of VEGF Trap-Eye with Lucentis(R)* (ranibizumab), an antiangiogenic agent approved for use in wet AMD in major markets globally.

Wet AMD accounts for about 90 percent of all severe AMD-related vision loss. It occurs when abnormal blood vessels in the eye leak fluid and blood into the macula, the area of the retina that allows for vision of fine details. This can lead to a rapid loss of central vision with continued progression.

"Results from the Phase 2 study have shown that VEGF Trap-Eye has the poten
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SOURCE Bayer HealthCare
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