Xibrom QD^™(once-daily)

In August 2009, ISTA announced positive preliminary Phase 3 results from the Company’s Xibrom^™ (bromfenac ophthalmic solution) QD (once-daily) confirmatory clinical study. Xibrom QD achieved statistical significance in the study’s primary endpoint, the absence of ocular inflammation 15 days following cataract surgery, and the secondary efficacy endpoint, the elimination of ocular pain one day post surgery. During the study, no serious ocular or systemic adverse events occurred, and the safety profile is consistent with ISTA's currently marketed Xibrom twice-daily formulation.

The confirmatory Phase 3 study was a multi-center, randomized, double-masked, parallel-group study in 299 patients who underwent cataract surgery in one eye. Patients were assigned randomly (1:1) to receive either Xibrom once daily or placebo. Dosing began one day before cataract surgery and continued for 14 days following surgery. The proportion of patients experiencing no pain was assessed at Day 1 post surgery, and the proportion of patients with complete absence of ocular inflammation was assessed at Day 15 post surgery. Ocular inflammation was evaluated using a summed ocular inflammation score (SOIS) and was measured by an assessment of immune cells in the anterior chamber of the eye ("cells") and cellular debris ("flare"). The secondary efficacy endpoint was evaluated via a pain score from the Ocular Comfort Grading Assessment recorded in a diary. Patients also graded their symptoms at each office visit, which included photophobia, the chief symptomatic complaint following cataract surgery.

In December 2008, ISTA announced integrated results from two Phase 3 studies with Xibrom QD. Based on the results of the studies, the U.S. Food and Drug Administration (FDA) required ISTA to conduct an additional confirmatory study with Xibrom QD. The current study confirms the efficacy and safety of Xibrom QD which was previously demonstrated in an identical Phase 3 clinical trial in 2008. Once the Company completes its analysis of the full dataset, ISTA expects to file a supplemental New Drug Application (sNDA) with the FDA prior to the end of 2009, seeking approval of the Xibrom formulation for once-daily treatment for the inflammation and pain following cataract surgery.

Xibrom^™ (bromfenac ophthalmic solution)

Xibrom is a topical non-steroidal anti-inflammatory compound for the treatment of ocular inflammation and pain following cataract surgery. Xibrom, under a different trade name but identical formulation, was launched in Japan in 2000 by Senju Pharmaceuticals Co. Ltd. ISTA acquired U.S. marketing rights for Xibrom in 2002 and launched the product in the U.S. in 2005.

Xibrom currently is labeled as an eye drop used twice-daily beginning 24 hours after cataract surgery. Xibrom has not been approved by the FDA as a once-daily treatment. ISTA’s sNDA filing will request the Agency to approve a change to the drug’s label to reflect Xibrom’s efficacy as a once-daily treatment in this patient population.