This Day On The Street
Continue to site
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

PSivida Corp. Announces Initiation Of Phase III Clinical Trial In Posterior Uveitis

pSivida Corp. (NASDAQ:PSDV), a specialty pharmaceutical company that is a leader in developing sustained release drugs for treatment of back-of-the-eye diseases, today announced that it has initiated the first of two planned pivotal Phase III trials of its micro-insert for the treatment of chronic, non-infectious uveitis affecting the posterior segment of the eye, a major cause of vision loss in the U.S.

“We are extremely pleased that our first three U.S. clinical sites have begun recruiting patients for this trial,” said Paul Ashton, Ph.D., President and CEO of pSivida. “We are very optimistic that our micro-insert will be efficacious for the treatment of posterior uveitis with a more favorable risk/benefit profile, fewer side effects and greater ease of administration than Retisert®, our current FDA-approved product for the treatment of the same disease.”

The micro-insert, a tiny tube about the size of an eyelash that releases the steroid fluocinolone acetonide on a sustained basis for up to 36 months, is the same micro-insert licensed by pSivida to Alimera Sciences, Inc. Alimera has received marketing approval for the micro-insert in six EU countries for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies and has commenced the direct commercialization of the micro-insert in Germany and the United Kingdom under the name ILUVIEN®. The FDA has set a new Prescription Drug User Fee Act (PDUFA) goal date of October 17, 2013 for ILUVIEN. pSivida did not license the micro-insert to Alimera for the treatment of uveitis and is developing this product without a partner.

This is the first of two pivotal trials required by the FDA for approval of the micro-insert for the treatment of posterior uveitis. These trials are planned to involve approximately 15 U.S. clinical sites and additional sites world-wide. Both trials will have a primary end-point of recurrence of posterior uveitis at 12 months and are planned to involve approximately 300 patients in total. If the results of the trials are positive, the data will be used by pSivida to submit a New Drug Application to the FDA. The FDA has confirmed that pSivida will be able to reference much of the data, including the clinical safety data, from Alimera’s Phase III clinical trials of ILUVIEN for chronic DME.

1 of 4

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr 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

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

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

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
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free
AAPL $94.02 0.00%
FB $104.07 0.00%
GOOG $683.57 0.00%
TSLA $162.60 0.00%
YHOO $27.97 0.00%


Chart of I:DJI
DOW 16,204.97 -211.61 -1.29%
S&P 500 1,880.05 -35.40 -1.85%
NASDAQ 4,363.1440 -146.4150 -3.25%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs