This Day On The Street
Continue to site right-arrow
ADVERTISEMENT
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

Regeneron Reports Positive Phase 3 Data For EYLEA® (aflibercept) Injection In Macular Edema Following Branch Retinal Vein Occlusion

Stocks in this article: REGN

TARRYTOWN, N.Y., Oct. 21, 2013 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive topline results for EYLEA ® (aflibercept) Injection from the Phase 3 VIBRANT study in patients with Macular Edema following Branch Retinal Vein Occlusion (BRVO).  In this trial, 53% of patients who received EYLEA 2 milligram (mg) every four weeks gained at least 15 letters in vision from baseline at week 24, the primary endpoint of the study, compared to 27% of patients who received laser, a standard-of-care treatment (p<0.001).  Patients who received EYLEA 2 mg every four weeks achieved a 17.0 letter mean improvement over baseline in best corrected visual acuity (BCVA) compared to a 6.9 letter mean improvement in patients who received laser (p<0.0001), a key secondary endpoint.  VIBRANT is the first Phase 3 trial in this indication in which an anti-VEGF agent was directly compared to an active comparator.

The incidence of serious adverse events (SAE) was 9.9% in the EYLEA group and 9.8% in the laser group.  One death and one Anti-Platelet Trialists' Collaboration (APTC) defined event (non-fatal stroke) occurred during the trial, both in patients in the laser group.  The most common ocular adverse events in the EYLEA treated patients were conjunctival hemorrhage and eye pain.  There were no cases of intraocular inflammation.  There was one ocular SAE in a patient in the EYLEA group, which was a traumatic cataract. 

"These positive data in patients with macular edema following BRVO further support the efficacy of EYLEA in a broad spectrum of retinal diseases," stated George D. Yancopoulos, M.D., Ph.D., Chief Scientific Officer of Regeneron and President of Regeneron Laboratories.  "If approved, we hope to be able to offer physicians and patients a new treatment option for addressing macular edema associated with this severe and potentially blinding retinal disorder."

"VIBRANT represents the eighth positive trial from the EYLEA Phase 3 program, which has enrolled over 3,800 patients from around the world and highlights our commitment to retinal diseases," said Robert Vitti, M.D., Vice President, Clinical Sciences, Ophthalmology, Regeneron Pharmaceuticals.  "We want to thank all the investigators and patients involved in this study.  We are proud of the effort consistently put forth by the EYLEA development team." 

Detailed results from this study will be presented at an upcoming medical conference.  Regeneron intends to submit a regulatory application for marketing approval for macular edema following BRVO in the U.S. within the next several months.

1 of 6

Check Out Our Best Services for Investors

Action Alerts PLUS

Jim Cramer and Stephanie Link reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

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
Stocks Under $10

Jim Cramer's protégé, 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
Try it NOW
Try it NOW
Try it NOW

Check Out Our Best Services for Investors

Dividend Stock Advisor

Jim Cramer's protégé, 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
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Options Profits

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

Product Features:
  • Actionable options commentary and news
  • Real-time trading community
Try it NOW
Try it NOW
Try it NOW
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!

Markets

DOW 17,164.95 -251.90 -1.45%
S&P 500 1,994.99 -26.26 -1.30%
NASDAQ 4,635.24 -48.1670 -1.03%

Partners Compare Online Brokers

Free Reports

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