“Age-related macular degeneration continues to be one of the leading causes of blindness in adults today,” said Leonard Schleifer, president and CEO of Regeneron. “Results of early phase studies have shown that VEGF Trap-Eye has the potential to be an important addition to the treatment alternatives available for patients with wet AMD.”
The Phase III study will be a non-inferiority comparison of the VEGF Trap-Eye and ranibizumab (marketed as Lucentis by Genentech), an anti-angiogenic agent approved for use in wet AMD. The randomized, double-masked Phase III study is expected to enroll approximately 1,200 patients in more than 200 centers throughout the US and Canada.
Vascular endothelial growth factor (VEGF) is a naturally occurring protein in the body whose normal role is to trigger 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.
The VEGF Trap-Eye is a fully human, soluble VEGF receptor fusion protein that binds all forms of VEGF-A along with the related placental growth factor (PlGF). The VEGF Trap-Eye is a specific and highly potent blocker of these growth factors. Blockade of VEGF, which can prevent abnormal blood vessel formation and vascular leak, has proven beneficial in the treatment of wet AMD, according to the company.