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Wet age-related macular degeneration : Eylea approved by European Commission


Bayer HealthCare has announced that Eylea ( Aflibercept solution for injection ), also known as VEGF Trap-Eye, has been approved by the European Commission ( EU ) for the treatment of patients with neovascular ( wet ) age-related macular degeneration ( wet AMD ) at a recommended dose of 2 mg.
Eylea treatment is initiated with one injection per month for three consecutive doses, followed by one injection every two months. There is no requirement for monitoring between injections.
After the first 12 months of treatment with Eylea, the treatment interval may be extended based on visual and anatomic outcomes. In this case the schedule for monitoring should be determined by the treating physician and may be more frequent than the schedule of injections.

Beyond wet AMD, Phase III trials with VEGF Trap-Eye have been completed for the treatment of macular edema following central retinal vein occlusion ( CRVO ) and are currently under way in the treatment of diabetic macular edema ( DME ) and myopic choroidal neovascularization ( mCNV ).

Eylea is already approved in the United States in wet AMD and in macular edema following CRVO.

Eylea 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 their cognate VEGF receptors.
Eylea is specially purified and contains iso-osmotic buffer concentrations, allowing for injection into the eye.

Eylea is contraindicated in patients with ocular or periocular infections, active intraocular inflammation, or known hypersensitivity to Aflibercept or to any of the excipients.

The most common adverse reactions ( 5% or more ) reported in patients receiving Aflibercept were conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and increased intraocular pressure. ( Xagena )

Source: Bayer HealthCare, 2012

XagenaMedicine_2012



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