New Drug Application tabled for Prolensa following positive phase III study in control of post-surgical inflammation

Positive phase III clinical trial data has supported the continuing development of a once-daily non-steroidal anti-inflammatory product for the treatment of ocular inflammation and pain following cataract surgery. The clinical study, sponsored by ISTA Pharmaceuticals, Inc., showed that Prolensa, a new modified ophthalmic NSAID formulation incorporating a lower concentration of bromphenac, met both primary and secondary endpoints with a statistically improved clearing of participants’ ocular inflammation by day 15. In addition, the data demonstrated that a greater proportion of study subjects were pain free one day after surgery compared with the placebo group.