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EYLEA® (aflibercept) Injection Receives Approval in Japan for the Treatment of Retinal Vein Occlusion

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TARRYTOWN, N.Y., June 26, 2015 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that Bayer HealthCare's Japanese subsidiary, Bayer Yakuhin, Ltd., received approval for EYLEA® (aflibercept) Injection by the Ministry of Health, Labour and Welfare (MHLW) in Japan for the treatment of patients with macular edema secondary to retinal vein occlusion (RVO). This new indication includes macular edema secondary to branch retinal vein occlusion (BRVO) in addition to the previously-approved indication of macular edema secondary to central retinal vein occlusion (CRVO).

The approval is based on positive results from the double-masked, randomized, active-controlled phase 3 VIBRANT study in patients with visual impairment due to macular edema secondary to BRVO. The primary endpoint was the proportion of subjects who gained at least 15 letters in best corrected visual acuity (BCVA) from baseline at week 24, as measured on the Early Treatment Diabetic Retinopathy Scale (ETDRS) eye chart, a standard chart used in research to measure visual acuity. More than half of the patients who were treated with aflibercept solution for injection gained at least three lines of vision.

Bayer HealthCare and Regeneron are collaborating on the global development of EYLEA. Regeneron maintains exclusive rights to EYLEA in the United States. Bayer HealthCare licensed the exclusive marketing rights outside the United States, where the companies share equally the profits from sales of EYLEA, except for Japan where Regeneron receives a percentage of net sales.

About Retinal Vein Occlusion 

RVO is a significant cause of vision impairment and a chronic disease that requires early and ongoing management to obtain the best possible vision.

Retinal vein occlusion (RVO) includes branch retinal vein occlusion (BRVO) and central retinal vein occlusion (CRVO). RVO is a chronic eye condition that can lead to sudden vision loss and is second only to diabetic retinopathy as the most frequent cause of visual loss from diseases affecting the blood vessels of the retina. While each patient experiences RVO differently, all patients are at risk for vision loss which can impact their ability to participate in everyday activities and may cause significant financial burden to patients, their families as well as broader society. RVO has a significant global impact with an estimated 16.4 million people affected worldwide, including around 13.9 million with BRVO and 2.5 million with CRVO.

RVO is the result of a blockage in a blood vessel of the retina, the light sensitive part of the eye. In CRVO, the blockage occurs in the main retinal vein at the optic nerve. In BRVO, the blockage occurs in one of the branch retinal veins. If a blockage in any of the retinal veins (central or branch) is not resolved, it can result in a number of complications. The most common reason for vision impairment in patients with RVO is macular edema, swelling of the macula, which is the central portion of the retina responsible for seeing fine details.

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 THE UNITED STATES

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. 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.

Please see the full U.S. Prescribing Information for EYLEA at www.EYLEA.com.

The product information is intended only for residents of the United States. The product discussed herein may have different labeling in different countries.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

About Regeneron Pharmaceuticals

Regeneron (NASDAQ: REGN) is a leading science-based biopharmaceutical company based in Tarrytown, New York that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including hypercholesterolemia, oncology, rheumatoid arthritis, asthma, and atopic dermatitis. For additional information about the company, please visit www.regeneron.com.

Forward-Looking Statements

This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. ("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; 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; ongoing regulatory obligations and oversight impacting Regeneron's marketed products (such as EYLEA® (aflibercept) Injection), 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 and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary) on the 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 Medicare and Medicaid; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its sales or other financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license or collaboration agreement, including Regeneron's agreements with Sanofi and Bayer HealthCare LLC, to be cancelled or terminated without any further product success; and risks associated with intellectual property of other parties and pending or future litigation relating thereto. A more complete description of these and other material risks can be found in Regeneron's filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the fiscal year ended December 31, 2014 and its Form 10-Q for the quarter ended March 31, 2015. Any forward-looking statements are made based on management's current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update publicly any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.

Your Investor Relations Contact at Regeneron:
Manisha Narasimhan, Ph.D. Tel. +1 (914) 847-5126  

E-Mail: manisha.narasimhan@regeneron.com  

Your Media Contact at Regeneron:
Ilana Tabak, Tel. +1 (914) 847-3836  

E-Mail: Ilana.Tabak@regeneron.com 


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SOURCE Regeneron Pharmaceuticals, Inc.

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