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
Stocks Under $10 with 50-100% upside potential - 14 days FREE!

ThromboGenics Activates 50th Retina Center For Its US Observational Patient Trial With JETREA(R) (ORBIT)

Stocks in this article: THR

LEUVEN, Belgium, April 29, 2014 (GLOBE NEWSWIRE) -- ThromboGenics NV (Euronext Brussels: THR), an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines for the back of the eye, todayannounces that the 50 th retina center has been activated to evaluate patients in the US ORBIT Phase IV study with JETREA ®. ORBIT (Ocriplasmin Research to Better Inform Treatment) is an observational study designed to generate further data on the real-world use of JETREA ® in the US.  Patient enrollment is open and underway at all activated sites.

ORBIT will recruit 1,500 patients with symptomatic vitreomacular adhesion (VMA) across 120 retina centers in the US. The prospective, observational study will assess clinical outcomes and safety of JETREA ® administered in a real-world setting for the treatment of symptomatic VMA/VMT by assessing both anatomical and functional outcomes.

The study will look at a number of parameters including resolution of VMA, Full Thickness Macular Hole (FTMH) closure, changes in visual acuity (VA) and occurrence and time to vitrectomy. It will also monitor adverse drug reactions (ADRs) and changes from baseline in ocular signs and symptoms across time. These data will further characterize the efficacy and safety profile of the product and provide data complementary to those from the phase III clinical program and its first 15 months on the market.  .

Patients will be followed for up to 12 months following treatment with JETREA ®. The ORBIT study is due to complete in mid-2016. Data will be presented on a regular basis. First data may be expected as early as by the end of 2014.

"I congratulate ThromboGenics on gathering real world data on the use of JETREA ® for the treatment of symptomatic vitreomacular adhesion. By analyzing this large cohort we will be able to better determine which patients most benefit from this treatment and to also see the results of surgical intervention if needed. With this observational study, incidence of adverse events and true success rate can be further characterized," said David Boyer, MD- Retina-Vitreous Associates Medical Group, Beverly Hills, CA.

Dr Patrik De Haes, CEO of ThromboGenics, comments : "We are pleased to see this high level of interest from the US retina community to take part in the ORBIT study. With 50 centers already in a position to recruit patients, we are optimistic that we can complete this study by mid-2016, with first data potentially available by end of 2014. ThromboGenics' decision to undertake the ORBIT study underwrites our commitment to help the community gain further knowledge about the real world use of JETREA ® and in particular to understand which patients gain the greatest benefit from the first pharmacological option for the treatment of symptomatic VMA/VMT. "

Ends

full press release http://hugin.info/137324/R/1780792/608976.pdf

HUG#1780792

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!

Markets

DOW 17,356.87 +288.00 1.69%
S&P 500 2,012.89 +40.15 2.04%
NASDAQ 4,644.3120 +96.4780 2.12%

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