PSivida Corp. (PSDV, PVA.AU) said its drug to treat
diabetes-related eye disease was found to be effective in eagerly
awaited results of two late-stage trials.
American Depositary Shares of the company soared 62.5% premarket
to $5.72. Through Tuesday, the stock had nearly quadrupled in
2009.
The two studies found that patients taking both a high dose and
a low dose of Iluvien, which is inserted into the eye, had more
improved vision compared with a control group receiving a "sham"
insertion. In addition, both the low and high doses showed greater
efficacy two years after starting treatment. PSvida had already
reported positive 18-month interim results from the study in
September.
The most significant adverse side effect was increased inner-eye
pressure, which showed up 22% of the time with the high dose and
16% of the time with the low dose.
The drug treats diabetic macular edema, a potentially blinding
eye disease affecting over 1 million people in the U.S. that
currently has no treatments approved by the Food and Drug
Administration.
PSivida reiterated its partner, Alimera Sciences Inc., will file
a new drug application with the FDA in the second quarter and
request priority view.
-By Joan E. Solsman, Dow Jones Newswires; 212-416-2291;
joan.solsman@dowjones.com