INVESTORS & MEDIA
News Release
Regeneron Announces Submission of Application for EYLEA® (aflibercept) Injection in Japan for Macular Edema Following Branch Retinal Vein Occlusion
EYLEA has already been approved in
EYLEA is approved in
About Macular Edema following Retinal Vein Occlusion (RVO)
RVO affects approximately one to two percent of adults over the age of 40.2 There are two main types of RVO: BRVO and CRVO. BRVO is four times more common than CRVO, and CRVO generally is the most significant threat to vision.1
RVO occurs when a blood clot obstructs a vein in the retina, the light-sensitive nerve tissue lining the back of the eye. The blockage causes a backup of blood and leads to poor blood supply in the affected retina. This results in the release of Vascular Endothelial Growth Factor (VEGF), a naturally-occurring protein in the body that causes blood vessels in the eye to become leaky. The leaky vessels lead to swelling in the center portion of the eye called the macula (a condition called macular edema), which is the most common cause of vision loss in RVO.1
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:
- Neovascular (wet) 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 CRVO. The recommended dose for EYLEA is 2 mg administered by injection in the eye monthly (every 4 weeks).
- Diabetic Macular Edema. 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. 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.
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.
Serious side effects related to the injection procedure are rare but can occur including infection inside the eye, retinal detachment, cataract, increased pressure in the eye, and vitreous 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.
The product information in this site is intended only for residents of
You 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
About
Regeneron Forward-Looking Statements
This news release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron, and actual events or results may differ materially from these forward-looking statements. Words such as "anticipate," "expect," "intend," "plan," "believe," "seek," "estimate," variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of Regeneron's products, product candidates, and research and clinical programs now underway or planned, including without limitation EYLEA® (aflibercept) Injection;
unforeseen safety issues resulting from the administration of products and product candidates in patients, including serious complications or side effects in connection with the use of Regeneron's product candidates in clinical trials; the likelihood and timing of possible regulatory approval and commercial launch of Regeneron's late-stage product candidates and new indications for marketed products, such as EYLEA® (aflibercept) Injection in the treatment of macular edema following branch retinal vein occlusion, and choroidal neovascularization secondary to pathologic myopia; ongoing regulatory obligations and oversight impacting Regeneron's research and clinical programs and business, including those relating to patient privacy; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron's ability to continue to develop or
commercialize Regeneron's products and product candidates; competing drugs and product candidates that may be superior to Regeneron's products and product candidates; uncertainty of market acceptance and commercial success of Regeneron's products and product candidates; the ability of Regeneron to manufacture and manage supply chains for multiple products and product candidates; coverage and reimbursement determinations by third-party payers, including
Your Investor Relations Contact at Regeneron:
E-Mail: manisha.narasimhan@regeneron.com
Your Media Contact at Regeneron:
E-Mail: sandra.sexton@regeneron.com
References
- Wong TY, Scott IU. Retinal-vein occlusion. N Engl J Med. 2010;363:2135-2144.
- Rogers S, McIntosh RL, Cheung N, et al. The prevalence of retinal vein occlusion: pooled data from population studies from
the United States ,Europe ,Asia andAustralia . Ophthalmology.2010;117(2):313-319.
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