Regeneron Announces EU Approval of EYLEA Injection for Treatment of Visual Impairment Secondary to Myopic Choroidal Neovascularization
In the EU, EYLEA is already approved for the treatment of patients with neovascular (wet) age-related macular degeneration, visual impairment due to diabetic macular edema, and visual impairment due to macular edema secondary to retinal vein occlusion (branch RVO or central RVO). In
About Myopic Choroidal Neovascularization
Myopic choroidal neovascularization is a disease of the retina in persons who are severely myopic (typically at least minus six diopters) and have pathological changes in the back of the eye. The disease is characterized by an abnormally elongated eye with a physical stretching of the sclera, choroid and retina, resulting in degenerative and progressive changes. These degenerative changes can induce the development of choroidal neovascularization.
About EYLEA® 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) INJECTIONS IN
EYLEA® (aflibercept) Injection is a prescription medicine approved for the treatment of patients with:
Wet Age-related Macular Degeneration (AMD): The recommended dose for EYLEA is 2 mg administered by injection in the eye every 2 months (8 weeks) following 3 initial monthly (4 weeks) injections. EYLEA may be dosed once per month, but additional benefit was not seen with this dosing plan.
Macular Edema following Retinal Vein Occlusion (RVO): The recommended dose for EYLEA is 2 mg administered by injection in the eye monthly (every 4 weeks).
Diabetic Macular Edema (DME) and Diabetic Retinopathy (DR) in patients with 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. You should not use EYLEA if you 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 with EYLEA can result in an infection in the eye and retinal detachment (separation of retina from back of the eye). Inflammation in the eye has been reported with the use of EYLEA.
In some patients, injections with EYLEA may cause a temporary increase in eye pressure within 1 hour of the injection. Sustained increases in eye pressure have been reported with repeated injections, and your doctor may monitor this after each injection.
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.
Serious side effects related to the injection procedure with EYLEA are rare but can occur 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 in the field of vision, increased pressure in the eye, and vitreous (gel-like substance) detachment. It is important that you contact your doctor right away if you think you might be experiencing any side effects.
EYLEA is for prescription use only. For additional safety information, please talk to your doctor and see the full Prescribing Information for EYLEA.
Please see the full U.S. Prescribing Information for EYLEA at www.EYLEA.com.
The product information is intended only for residents of
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