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News Release
EYLEA® (aflibercept) Injection Recommended for Approval for the Treatment of Visual Impairment Due to Macular Edema Secondary to Central or Branch Retinal Vein Occlusion in the European Union
EYLEA is approved in
About Retinal Vein Occlusion
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).
About EYLEA® (aflibercept) Injection for Intravitreal Injection
EYLEA 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. EYLEA helps prevent VEGF-A and PLGF from interacting with their natural VEGF receptors as shown in preclinical studies.
IMPORTANT PRESCRIBING INFORMATION FOR EYLEA® (aflibercept) INJECTION IN
EYLEA® (aflibercept) Injection is indicated for the treatment of patients with:
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.
Macular Edema following Retinal Vein Occlusion (RVO): The recommended dose for EYLEA is 2 mg administered by intravitreal injection monthly (every 4 weeks).
Diabetic Macular Edema (DME): The recommended dose for EYLEA is 2 mg administered by injection in the eye every 2 months (8 weeks) following 5 initial monthly (4 weeks) injections. EYLEA may be dosed once per month, but additional benefit was not seen with this dosing plan.
IMPORTANT SAFETY INFORMATION FOR EYLEA® (aflibercept) INJECTION
EYLEA® (aflibercept) Injection is a prescription medication administered by injection into the eye. 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 in EYLEA, 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, and doctors may monitor this after each injection.
There is potential risk of serious and sometimes fatal side effects related to blood clots, leading to heart attack 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 (gel-like substance) detachment.
It is important that patients contact their doctor right away if they think they might be experiencing any side effects.
EYLEA is for prescription use only. For additional safety information, please see full Prescribing Information for EYLEA.
Patients are encouraged to report negative side effects of prescription drugs to the
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