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

European Medicines Agency Approves Positive Opinion On Omeros' Pediatric Investigation Plan For OMS302

Stocks in this article: OMER

SEATTLE, July 2, 2013 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today announced that the European Medicines Agency (EMA) approved a positive opinion issued by the European Pediatrics Committee (PDCO) agreeing to the Company's Pediatric Investigation Plan (PIP) for OMS302. EMA's approval of PDCO's positive opinion is a prerequisite for submission of the OMS302 Marketing Authorization Application (MAA) and, on completion of the post-marketing pediatric study, leads to an additional six months of patent exclusivity for OMS302 in Europe. OMS302, added to standard irrigation solution used during ophthalmological procedures, is Omeros' proprietary PharmacoSurgery™ product designed to maintain intraoperative mydriasis (pupil dilation), prevent surgically induced miosis (pupil constriction), and reduce postoperative pain resulting from cataract and other lens replacement surgery. 

Omeros' PIP provides a study plan to evaluate the drug's safety and efficacy in patients 13-17 years old. Omeros received a waiver for studying the use of OMS302 in patients younger than 13 years and a deferral to complete the clinical study following EMA approval. With completion of the study as specified under the PIP, Omeros will be eligible to receive an additional six months of marketing exclusivity for OMS302 in the European Union (E.U.). This six-month period would extend beyond the expiration of Omeros' patents directed to OMS302, which will expire in the E.U. in 2023 for issued patents and 2033 for patents expected to issue from currently pending patent applications. This six-month extension is in addition to a supplementary protection certificate, which together could provide up to another five and one half years of market exclusivity for OMS302. Omeros is pursuing a similar but separate process in the U.S. for studying the use of OMS302 in pediatric patients, which is expected to lead to additional marketing exclusivity in the U.S. Submission of the New Drug Application (NDA) for OMS302 in the U.S. will precede the MAA submission, and both applications will include additional stability data to extend expiry dating at the time of expected commercial launch.

1 of 2

Select the service that is right for you!

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 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

  • 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