Ista reports positive Phase III results for ocular inflammation drug

The program enrolled 282 patients who underwent cataract surgery in two US multi-center, randomized, double-masked, parallel-group, vehicle-controlled studies to evaluate Xibrom (0.09% bromfenac sodium ophthalmic solution) dosed once daily to vehicle (placebo). The identical trials were performed under a common protocol and designated the East region trial (ER) and the West region trial (WR).

According to a preliminary analysis, integrated results for the two studies demonstrated Xibrom 0.09% QD achieved statistical significance in meeting the primary efficacy endpoint of absence of ocular inflammation 15 days following surgery. In addition, Xibrom 0.09% QD met the secondary efficacy endpoint of elimination of ocular pain one day post surgery.

When considered independently, the WR trial showed statistical significance in both the primary and secondary efficacy endpoints. The ER exhibited strong trends in both the absence of ocular inflammation and pain but did not meet statistical significance for either. The rate of patients who discontinued due to lack of efficacy in the ER was six times greater than the WR trial and a previous clinical trial utilizing the same protocol and concentration, the company said.

In addition, both Phase III studies showed highly statistically significant results in the proportion of subjects with no photophobia at every study visit post-cataract surgery. The studies also showed no serious ocular or systemic adverse events, and the safety profile is consistent with Ista’s currently marketed Xibrom twice-daily formulation.

Ista has discussed the data with the FDA and plans to perform a confirmatory Phase III trial that it expects to complete in 2009.