Bayer HealthCare AG and development partner Regeneron Pharmaceuticals, Inc. have announced that the first patient has been dosed in the new View 2 trial, a second phase III clinical study in a development programme 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 enrol approximately 1,200 patients in up to 200 centres in Europe, Asia Pacific, Japan and Latin America. The first phase III 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 (ranibizumab) an antiangiogenic agent approved for use in wet AMD in major markets globally.

Wet AMD accounts for about 90 per cent 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 II study have shown that VEGF Trap-Eye has the potential to significantly reduce retinal thickness and improve vision," said Kemal Malik, MD, Head of global development and member of the Bayer HealthCare executive committee. "Dosing of the first patient in this confirmatory phase III trial is an important milestone for this compound intended to treat a devastating ocular disease that impacts millions of people worldwide".

"New therapies are still needed to provide optimal care to those patients with wet AMD," said George D Yancopoulos, MD, Ph.D., president of Regeneron Research Laboratories. "This global phase III clinical programme will provide additional data to further evaluate the efficacy and safety of VEGF Trap-Eye using different dosing regimens".

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.

Vascular endothelial growth factor (VEGF) is a naturally occurring protein in the body whose normal role is to trigger the formation of new blood vessels (angiogenesis) to support the growth of the body's tissues and organs. It has also been associated with the abnormal growth and fragility of new blood vessels in the eye, which lead to the development of wet AMD.