ISTA Pharmaceuticals Inc. announced the preliminary analysis of a late-stage trial in Xibrom QD. Xibrom is a topical non-steroidal anti-inflammatory compound for the treatment of ocular inflammation and pain following cataract surgery.
The result shows to have achieved statistical significance in meeting the primary efficacy endpoint of absence of ocular inflammation 15 days following surgery.
The company recently completed Phase III clinical program of Xibrom QD. The program enrolled 282 patients who underwent cataract surgery in two U.S. multi-center, parallel-group, vehicle-controlled studies to evaluate Xibrom 0.09% dosed once daily to vehicle (placebo).
ISTA said it has discussed the data with the FDA and plans to perform a confirmatory Phase III trial that it expects to complete in 2009.
Source: RTT News