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Eylea injection for the treatment of visual impairment due to macular edema secondary to central or branch retinal vein occlusion, positive CHMP opinion


Eylea ( Aflibercept ) injection has been recommended for approval by the European Committee for Medicinal Products for Human Use ( CHMP ) for the treatment of visual impairment due to macular edema secondary to central or branch retinal vein occlusion ( CRVO / BRVO ).

The European Union ( EU ) submission is based on the previously-approved indication for macular edema secondary to CRVO and the positive data from the phase 3 VIBRANT study.

Eylea is approved in the United States for the treatment of neovascular ( wet ) age-related macular degeneration ( AMD ), macular edema following retinal vein occlusion ( RVO ), which includes both CRVO and BRVO, and diabetic macular edema ( DME ).
Eylea has also been approved in the EU and other markets for use in wet age-related macular degeneration and diabetic macular edema.

Retinal vein occlusion ( RVO ) is the second most common retinal vascular disease and is a significant cause of visual impairment. Of the two main types of retinal vein occlusion, CRVO and BRVO, the latter is more common.
In BRVO, a blockage occurs in the blood vessels branching from the main vein draining the retina, resulting in the release of vascular endothelial growth factor and consequent retinal edema.
Retinal Vein Occlusion ( RVO ) has a significant global impact with an estimated 16.4 million people affected worldwide, including around 13.9 million with branch retinal vein occlusion ( BRVO ) and 2.5 million with central retinal vein occlusion ( CRVO ).

Aflibercept is a vascular endothelial growth factor ( VEGF ) inhibitor formulated as an injection for the eye. Aflibercept blocks 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 they have an infection in or around the eye, eye pain or redness, or known allergies to any of the ingredients, including Aflibercept.

As with all medicines, Eylea can cause side effects. Injections 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 injection.
Sustained increases in eye pressure have been reported with repeated inejctions.
There is potential risk of serious and sometimes fatal side effects related to blood clots, leading to myocardial infarction or stroke in patients receiving Eylea.
Serious side effects related to the injection procedure are rare but can occure including infection inside the eye and retinal detachment.
The most common side effects reported in patients receiving Eylea are increased redness in the eye, eye pain, cataract, moving spots of vision, increased pressure in the eye, and vitreous detachment. ( Xagena )

Source: Regeneron Pharmaceuticals, 2015

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