FDA approves Prolensa (Ista/Bausch & Lomb) for postoperative Ocular Inflammation

The FDA has approved Prolensa (bromfenac ophthalmic solution) 0.07 percent prescription eye drop, from Ista/Bausch & Lomb, for the treatment of postoperative Ocular Inflammation and reduction of Ocular pain in patients who have undergone cataract surgery. The efficacy of Prolensa was evaluated in two randomized, double-masked, vehicle-controlled studies of patients undergoing cataract surgery. Twice as many patients as vehicle (46 percent versus 20 percent) demonstrated complete clearance of inflammation (SOIS of 0) at day 15.

The difference in the average post-operative inflammation severity between the treatment and vehicle arms was statistically and clinically significant by day eight. Nearly four of five patients treated with Prolensa were pain free at day one (78.8 percent versus 49.5 percent for vehicle; p<0.0001). patients treated with prolensa reported a lower incidence of foreign body sensation and photophobia and had less redness than those treated with vehicle.>