The VEGF Trap is a fusion protein specifically designed to bind all forms of Vascular Endothelial Growth Factor-A (VEGF-A) and Placental Growth Factor (PLGF). Both VEGF-A and PLGF are proteins that are involved in the abnormal growth of new blood vessels.

Regeneron and Bayer HealthCare are collaborating on the global development, and commercialization outside the U.S., of VEGF Trap-Eye for the treatment of eye disease by local administration. Regeneron maintains exclusive commecialization rights in the U.S. VEGF Trap-Eye is specifically purified and formulated for intravitreal administration.

Age-related Macular Degeneration (AMD) and Diabetic Retinopathy (DR)

Age-related Macular Degeneration (AMD) is a leading cause of acquired blindness. In wet AMD, new blood vessels grow beneath the retina and leak blood and fluid. This leakage causes disruption and dysfunction of the retina, creating blind spots in central vision, and it can account for blindness in wet AMD patients. Wet AMD is the leading cause of blindness for people over the age of 65 in the US and Europe.

Diabetic Retinopathy (DR) can lead to significant vision impairment and is a major complication of diabetes. Diabetic Macular Edema (DME) is a common complication of DR that involves fluid collection in the macula. DME is the most prevalent cause of moderate visual loss in patients with diabetes.

Combined, wet AMD and DME are two of the leading causes of adult blindness in the developed world. In both conditions, severe visual loss is caused by a combination of fluid build-up around the retina and the unnatural growth of blood vessels in the back of the eye.

Counteracting the effects of VEGF-A and PLGF may provide a significant therapeutic benefit to patients suffering from these disorders.

VEGF Trap-Eye Clinical Development

In August 2007, Regeneron and Bayer HealthCare initiated a Phase 3 development program evaluating VEGF Trap-Eye in the neovascular form of wet Age-related Macular Degeneration (AMD). Two trials are comparing treatment with VEGF Trap-Eye and Lucentis® (ranibizumab), a trademark of Genentech, Inc., an anti-angiogenic agent approved for use in wet AMD. The Phase 3 global development program in wet AMD is carried out in the U.S., Europe, and other parts of the world. In 2008, Regeneron and Bayer HealthCare also initiated a Phase 2 study of VEGF Trap-Eye in patients with Diabetic Macular Edema (DME).

This section discusses Regeneron's pipeline of drug candidates currently undergoing clinical testing in a variety of diseases. These drug candidates have not been approved by the United States Food and Drug Administration for the indications described in this section.