We are developing a new formulation, lower concentration BROMDAY, called PROLENSA™, for postoperative inflammation and reduction of ocular pain in patients who have undergone cataract extractions. We initiated a Phase 3 study in April of 2011 and in October 2011 reported that in both Phase 3 studies, PROLENSA was statistically significantly better than placebo and met the primary efficacy endpoint of absence of ocular inflammation 14 days following surgery and the secondary efficacy endpoint of elimination of ocular pain one day post-surgery.  There were no serious drug-related ocular or systemic adverse events, and PROLENSA’s safety profile was found to be consistent with ISTA's currently marketed topical non-steroidal anti-inflammatory (NSAID) compound, BROMDAY™ (bromfenac ophthalmic solution) 0.09%.  This study had the lowest number of adverse events (greater than 2%) than any of our bromfenac clinical trials for cataract surgery to date. And, to the best of our knowledge, PROLENSA contains the lowest concentration of bromfenac currently under investigation in any clinical trials for inflammation and pain associated with cataract surgery.

We plan to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for PROLENSA in the first half of 2012, with a commercial launch planned for early 2013.

Based upon 2011 data from IMS Health, we estimate that 2011 sales in the U.S. topical ophthalmic non-steroidal anti-inflammatory market were approximately $370 million, with total prescriptions of more than 3 million.