This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
TheStreet Open House

EYLEA® (aflibercept) Injection Receives EU Approval For The Treatment Of Diabetic Macular Edema (DME)

Stock quotes in this article: REGN

TARRYTOWN, N.Y., Aug. 11, 2014 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that EYLEA ® (aflibercept) Injection has been approved by the European Commission for the treatment of visual impairment due to Diabetic Macular Edema (DME).  Bayer Healthcare plans to launch EYLEA in DME in the EU this quarter.

"DME is the leading cause of vision loss in working-age adults in much of the developed world, and we believe EYLEA will be an important new treatment option for these patients," said George D. Yancopoulos, M.D., Ph.D., Chief Scientific Officer of Regeneron and President of Regeneron Laboratories.  "We are pleased that EYLEA is now approved in both the U.S. and the EU for three important ophthalmic indications."

EYLEA was approved in the United States for the treatment of wet Age-related Macular Degeneration (AMD) in 2011, for the treatment of Macular Edema following Central Retinal Vein Occlusion (CRVO) in 2012, and for DME in July 2014.  EYLEA has also been approved in the EU and other countries for use in wet AMD and Macular Edema following CRVO.  Regulatory submissions have also been made in Japan, Asia Pacific, and Latin America for the treatment of DME.  In Japan, EYLEA has been additionally submitted for approval to regulators for the treatment of choroidal neovascularization secondary to pathologic myopia (mCNV).  A regulatory submission has been made in the U.S. and the EU for EYLEA for the treatment of Macular Edema following Branch Retinal Vein Occlusion (BRVO).

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 3-4 percent of people with diabetes and is therefore the most frequent cause of blindness in young and middle-aged adults in most developed countries.  As the incidence of diabetes has been steadily climbing, it is projected that the number of people impacted by DME will also grow.

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.

1 of 3

Select the service that is right for you!

COMPARE ALL SERVICES
Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!
DOW 16,804.71 -238.19 -1.40%
S&P 500 1,946.16 -26.13 -1.32%
NASDAQ 4,422.0850 -71.3050 -1.59%

Brokerage Partners

Rates from Bankrate.com

  • Mortgage
  • Credit Cards
  • Auto

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs