Prolensa bromfenac: Additional Phase III data

Additional data from a double-blind, U.S. Phase III trial in 220 patients undergoing unilateral cataract surgery showed that 49.1% of patients receiving once-daily Prolensa achieved complete absence of ocular inflammation at day 14 post-surgery, the primary endpoint, vs. 31.8% for placebo (p=0.0132). Additionally, 76.4% of patients receiving Prolensa experienced no pain at day 1 post-surgery, a secondary endpoint, vs. 55.5% for placebo (p=0.0017). Patients began dosing with once-daily Prolensa or placebo 1 day before surgery and continued treatment for 14 days following surgery. Data were presented at the Association for Research in Vision and Ophthalmology meeting in Fort Lauderdale.

Last month, Ista reported data from a separate Phase III trial in 220 patients undergoing unilateral cataract surgery showing that 48.2% of patients receiving Prolensa achieved complete absence of ocular inflammation at day 14 post-surgery, the primary endpoint, vs. 16.7% for placebo (p<0.0001) (see BioCentury, May 7). Last year, the company reported top-line data from both Phase III trials showing that Prolensa met the primary and secondary endpoints vs. placebo (see BioCentury, Oct. 17, 2011). ...