Regeneron And Bayer Initiate Phase 3 Clinical Program For The Treatment Of Wet Age-Related Macular Degeneration In China

About Wet AMD

Age-related Macular Degeneration (AMD) is a leading cause of acquired blindness.  Macular degeneration is diagnosed as either dry (non-exudative) or wet (exudative).  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 U.S. and Europe.  In China, there were an estimated 540,000 newly diagnosed wet AMD patients over the age of 50 in 2010.







About EYLEA™ (aflibercept ) Injection For Intravitreal Injection

Vascular Endothelial Growth Factor (VEGF) is a naturally occurring protein in the body.  Its normal role in a healthy organism is to trigger formation of new blood vessels (angiogenesis) supporting the growth of the body's tissues and organs.  However, in certain diseases, such as wet age-related macular degeneration, it is also associated with the growth of abnormal new blood vessels in the eye, which exhibit abnormal increased permeability that leads to edema. Scarring and loss of fine-resolution central vision often results. 

EYLEA, known in the scientific literature as VEGF Trap-Eye, is a recombinant fusion protein, consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 and formulated as an iso-osmotic solution for intravitreal administration.  EYLEA acts as a soluble decoy receptor that binds VEGF-A and placental growth factor (PlGF) and thereby can inhibit the binding and activation of these cognate VEGF receptors.

IMPORTANT PRESCRIBING INFORMATION

In this U.S. EYLEA is indicated for the treatment of patients with neovascular age-related macular degeneration (wet AMD). 

The recommended dose for EYLEA is 2 mg administered by intravitreal injection every four weeks (monthly) for the first 12 weeks (3 months), followed by 2 mg once every eight weeks (2 months).  Although EYLEA may be dosed as frequently as 2 mg every four weeks (monthly), additional efficacy was not demonstrated when EYLEA was dosed every four weeks compared to every eight weeks.

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