Ista Pharmaceuticals Inc., an Irvine-based drug maker, said Wednesday that one of its eye drug candidates met goals in a late-stage clinical trial.
Ista said that Xibrom QD did significantly better than a placebo at eliminating eye inflammation 15 days after cataract surgery and achieved a secondary goal of eliminating eye pain a day after surgery.
Xibrom QD is a once-per-day version of Ista’s original Xibrom eye drop, which is intended to be used twice daily.
Ista conducted its trial on 299 people who had cataract surgery on one eye.
The drug maker said it expects to file for Food and Drug Administration approval of Xibrom QD by the end of 2009.
Last year, regulators asked Ista to run a third late-stage trial of Xibrom QD to confirm results from earlier trials.
Ista is developing Xibrom QD at a time when its original Xibrom, which has accounted for three-fourths of Ista’s $44.4 million in revenue through the first six months of the year, has come off of patent protection.
