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Drug Maker Ista Reports Mixed Trial Results
(Oct 13)
Irvine-based Ista Pharmaceuticals Inc. on Thursday said that a cataract drug met the main goal of two late-stage clinical trials but its dry eye drug missed on a second late-stage trial.
Ista’s Prolensa, a drug for inflammation and pain in patients who have undergone cataract surgery, showed that it was significantly better than a placebo and met its main goal of the absence of eye inflammation 14 days following surgery, the company said.
Ista said that it plans to file a Food and Drug Administration marketing application for Prolensa in the first quarter of 2012. Possible commercial introduction could come in late 2012 or early 2013.
The drug maker said its Remura for dry eyes failed to show statistically significant improvement in patients suffering compared with a placebo. Remura also failed to show statistically significant improvement in a late-stage clinical trial in July.
Ista said it “will complete a full analysis of the data, but focus our efforts on the potential use of (Remura) as an over-the-counter artificial tear product.”
Ista’s Prolensa, a drug for inflammation and pain in patients who have undergone cataract surgery, showed that it was significantly better than a placebo and met its main goal of the absence of eye inflammation 14 days following surgery, the company said.
Ista said that it plans to file a Food and Drug Administration marketing application for Prolensa in the first quarter of 2012. Possible commercial introduction could come in late 2012 or early 2013.
The drug maker said its Remura for dry eyes failed to show statistically significant improvement in patients suffering compared with a placebo. Remura also failed to show statistically significant improvement in a late-stage clinical trial in July.
Ista said it “will complete a full analysis of the data, but focus our efforts on the potential use of (Remura) as an over-the-counter artificial tear product.”