FDA to Review ISTA Eye Drug by October 16
IRVINE, Calif. (AP) — ISTA Pharmaceuticals Inc. has announced that the Food and Drug Administration will make a regulatory decision on the once-daily eye inflammation treatment XiDay by Oct. 16.
The drug is a once-per-day version of Xibrom, a drug that is already on the market but is intended to be used twice a day.
XiDay, like Xibrom, is aimed at treating eye inflammation following cataract surgery.
ISTA said the FDA is still considering the company's request for a shorter, six-month, priority review.
ISTA reported Xibrom net sales of $81.1 million for the year ended December 31, 2009.