Bausch & Lomb announced that the FDA has approved its New Drug Application (NDA) for Prolensa (bromfenac) ophthalmic solution indicated for the treatment of post-operative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. Bromfenac is a non-steroidal anti-inflammatory drug (NSAID).
The efficacy of Prolensa was evaluated in two randomized, double-masked, vehicle-controlled studies of patients undergoing cataract surgery. The primary efficacy endpoint was complete clearing of ocular inflammation (assessed by the SOIS score, which includes cells and flare) by Day 15. Results showed that Prolensa was superior to the vehicle in treatment of both post-operative inflammation and pain. Twice as many patients treated with Prolensa demonstrated complete clearance of inflammation at Day 15 compared to vehicle (46% vs. 20%), and about four of five patients were pain free at Day 1 (78.8% vs. 49.5% vehicle; P<0.0001).
Prolensa ophthalmic solution will be available in a 0.07% strength in 1.6mL and 3mL bottles.
For more information call (800) 323-0000 or visit www.bausch.com.