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news.Bayer HealthCare and Regeneron Pharmaceuticals have announced that the first patient has been dosed in the View 2 trial, a second Phase III clinical study in a development program evaluating VEGF Trap-Eye for the treatment of the neovascular form of age-related macular degeneration.
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View 2 will enroll approximately 1,200 patients in up to 200 centers in Europe, Asia Pacific, Japan and Latin America. The first Phase III trial, View 1, began enrolling patients in August 2007 in the US 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 four and eight 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 (ranibizumab), an antiangiogenic agent approved for use in wet neovascular form of age-related Macular Degeneration (wet AMD).
Bayer HealthCare and Regeneron are collaborating on the global development of VEGF Trap-Eye for treatment of wet AMD, diabetic eye diseases, and other ocular diseases and disorders. Once approved, Bayer HealthCare will market VEGF Trap-Eye outside the US, where the parties will share equally in profits from any future sales of VEGF Trap-Eye. Regeneron maintains exclusive rights to VEGF Trap-Eye in the US. View 2 primary analysis results are anticipated in 2011.