Drugs Xagena
Eylea ( Aflibercept ) injection has been approved by the European Commission for the treatment of visual impairment due to diabetic macular edema ( DME ).
Diabetetic macular edema is the leading cause of vision loss.
Eylea was approved in the United States for the treatment of wet age-related macular degeneration ( AMD ) in 2011, for the
treatment of macular edema following central retinal vein occlusion ( CRVO ) in 2012, and for diabetic macular edema in July 2014.
Eylea has also been approved in the European Union ( EU ) and other countries for use in wet age-related macular degeneration and macular edema following CRVO.
Diabetic macular edema or swelling of the macula is a common complication in the eyes of patients with diabetes mellitus. It is the most frequent cause of vision loss in patients with diabetes and eventually can lead to blindness.
Visual impairment due to diabetic macular edema is estimated to affect 3-4% of people with diabetes mellitus and is therefore the most frequent cause of blindness in young and middle-aged adults in most developed countries.
As the incidence of diabetes mellitus has been steadily climbing, it is projected that the number of people impacted by diabetic macular edema will also grow.
Diabetic macular edema occurs when blood vessels in the retina are damaged by chronic high blood sugar levels caused by diabetes mellitus. This allows fluid from blood vessels to leak into the retina, causing macular swelling. Fluid in the macula can cause severe vision loss or blindness.
The macula is the part of the retina responsible for central fine vision.
Vascular endothelial growth factor ( VEGF ), a member of a naturally occurring family of growth factors in the body, appears to play a critical role in the development of diabetic macular edema. Increased VEGF production contributes to the vascular disruptions and leakage that characterize diabetic macular edema, as well as the formation of new blood vessels ( a process known as angiogenesis ).
Aflibercept is a vascular endothelial growth factor ( VEGF ) inhibitor formulated as an injection for the eye. Eylea is designed to block the growth of new blood vessels and decrease the ability of fluid to pass through blood vessels ( vascular permeability ) in the eye by blocking VEGF-A and placental growth factor ( PLGF ), two growth factors involved in angiogenesis.
Aflibercept helps prevent VEGF-A and PLGF from interacting with their natural VEGF receptors as shown in preclinical studies.
Patients should not use Eylea if have an infection in or around the eye, eye pain or redness, or known allergies to any of the ingredients in Eylea, including Aflibercept.
Injection into the eye can result in an infection in the eye and retinal detachment. Inflammation in the eye has been reported
with the use of Eylea.
In some patients, injections with Eylea may trigger a temporary increase in eye pressure within 1 hour of the injection.
Sustained increases in eye pressure have been reported with repeated injections.
There is a potential risk of serious and sometimes fatal side effects related to blood clots, leading to heart attack or stroke in
patients receiving Eylea.
The most common side effects reported in patients receiving Eylea are increased redness in the eye, eye pain, cataract,
moving spots in the field of vision, increased pressure in the eye and vitreous detachment. ( Xagena )
Source: Regeneron, 2014
XagenaMedicine_2014
