INVESTORS & MEDIA
News Release
Regeneron Announces EYLEA® (aflibercept) Injection Approved for the Treatment of Diabetic Macular Edema (DME) in Japan
EYLEA has already been approved in
EYLEA is approved in the U.S. for wet AMD, DME and macular edema following retinal vein occlusion (RVO).
EYLEA has been approved in almost 80 countries for the treatment of patients with wet AMD and around 60 countries for the treatment of visual impairment due to macular edema secondary to central retinal vein occlusion. EYLEA is also approved for the treatment of DME in over 30 countries. Bayer has submitted an application for marketing authorization in
About Diabetic Macular Edema (DME)
Diabetic macular edema (DME) or "swelling of the macula" is a common complication in the eyes of patients with diabetes. It is the most frequent cause of vision loss in patients with diabetes and eventually can lead to blindness.1,2 Visual impairment due to DME is estimated to affect around three percent of people with diabetes around the world and is the most frequent cause of blindness in young and mid-aged adults in most developed countries.3,4
DME occurs when blood vessels in the retina are damaged by chronic high blood sugar levels caused by diabetes. This allows fluid from blood vessels to leak into the retina, causing macular swelling. Fluid in the macula can cause severe vision loss or blindness. The macula is the part of the retina responsible for central, fine vision.
Vascular endothelial growth factor (VEGF), a naturally occurring family of growth factors in the body, appears to play a critical role in the development of DME. Increased VEGF production contributes to the vascular disruptions and leakage that characterize DME, as well as the formation of new blood vessels (a process known as angiogenesis).
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 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): 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 medications, EYLEA can cause side effects.
Injection 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 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 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 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, see the full Prescribing Information for EYLEA.
Patients are encouraged to report negative side effects of prescription drugs to the
About the EYLEA® (aflibercept) Injection Global Collaboration
About
Regeneron is a leading science-based biopharmaceutical company based in
For additional information about the company, please visit www.regeneron.com.
Forward-Looking Statements
This news release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of
Your Investor Relations Contact at Regeneron:
E-Mail: manisha.narasimhan@regeneron.com
Your Media Contact at Regeneron:
E-Mail: sandra.sexton@regeneron.com
References:
- Ho A, Scott I, Kim S, et al. Anti-vascular endothelial growth factor pharmacotherapy for diabetic macular edema: a report by the
American Academy of Ophthalmology . Ophthalmology. 2012; 119(10): 2179-2188. - Ciulla T, Amador A, Zinman B. Diabetic retinopathy and diabetic macular edema: pathophysiology, screening, and novel therapies. Diabetes Care. 2003; 26(9): 2653-2664.
- Petrella, RJ et al. "Prevalence, Demographics, and Treatment Characteristics of Visual Impairment due to Diabetic Macular Edema in a Representative Canadian Cohort,"
Journal of Ophthalmology , vol. 2012, Article ID 159167, 6 pages, 2012. doi:10.1155/2012/159167. - Minassian DC et al. Prevalence of diabetic macula edema and related health and social care resource use in
England . Br J Ophthalmol. 2012 Mar;96(3):345-9
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