The FDA turned thumb's down on ISTA Pharmaceuticals T-Pred topical steroid for inflammatory eye conditions. Regulators rejected ISTA's contention that the trial data supported its position that the therapy was equivalent to other products already approved to treat similar conditions. ISTA shares plunged 19 percent on the news.
"We believe our clinical study met the endpoints that ISTA and the FDA agreed to in the Special Protocol Assessment," chief executive Vicente Anido said in a statement. "We plan to work closely with the agency to resolve this issue in an efficient manner."
- see this release on the rejection
- read the AP report for more
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