The VEGF Trap is a unique fusion protein that binds 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 US, of the VEGF Trap-Eye for the treatment of eye disease by local administration. Regeneron maintains exclusive commecialization rights in the US

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, which affects 20.8 million Americans. 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, these diseases 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

A phase 3 study, VIEW 1, is currently enrolling patients. The VIEW 1 study is comparing the VEGF Trap-Eye and ranibizumab (Lucentis®, a registered trademark of Genentech, Inc.), an antiangiogenic agent approved for use in wet AMD. In a phase 2 study evaluating VEGF Trap-Eye in the neovascular form of wet Age-related Macular Degeneration (AMD), the VEGF Trap-Eye met the primary endpoint of a statistically significant reduction in retinal thickness and demonstrated statistically significant improvement in visual acuity after 12 weeks as compared to baseline. There were no drug-related serious adverse events, and treatment with the VEGF Trap-Eye was generally well-tolerated.

A small pilot study in DME has also been completed, and Regeneron plans to conduct advanced studies of the VEGF Trap-Eye in 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.