In the United States, Eylea ( Aflibercept ) injection is indicated for the treatment of patients with neovascular ( wet ) age-related macular degeneration ( AMD ).
The recommended dose for Eylea is 2 mg administered by intravitreal injection every 4 weeks ( monthly ) for the first 12 weeks ( 3 months ), followed by 2 mg once every 8 weeks ( 2 months ).
Although Eylea may be dosed as frequently as 2 mg every 4 weeks ( monthly ), additional efficacy was not demonstrated when Eylea was dosed every 4 weeks compared to every 8 weeks.

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 age-related macular degeneration, new blood vessels grow beneath the retina and leak blood and fluid. This leakage causes disruption and dysfunction of the retina creating distortion and/or blind spots in central vision.
Wet AMD is the leading cause of blindness for people over the age of 65 in the United States and Europe.

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

Intravitreal injections, including those with Aflibercept, have been associated with endophthalmitis and retinal detachments. Proper aseptic injection technique must always be used when administering Aflibercept. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay and should be managed appropriately.

Acute increases in intraocular pressure have been seen within 60 minutes of intravitreal injection, including with Aflibercept. Sustained increases in intraocular pressure have also been reported after repeated intravitreal dosing with VEGF inhibitors. Intraocular pressure and the perfusion of the optic nerve head should be monitored and managed appropriately.

There is a potential risk of arterial thromboembolic events following use of intravitreal VEGF inhibitors, including Aflibercept, defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death ( including deaths of unknown cause ). The incidence of thromboembolic events with Aflibercept in clinical trials was low ( 1.8% ).

Serious adverse reactions related to the injection procedure have occurred in less than 0.1% of intravitreal injections with Aflibercept including endophthalmitis, traumatic cataract, and increased intraocular pressure.

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

Source: Regeneron, 2011

XagenaMedicine2011