Bausch + Lomb receives FDA approval for Prolensa

April 9, 2013

Prolensa (bromfenac ophthalmic solution) 0.07% has received FDA approval for treating postop inflammation and ocular pain reduction following cataract surgery.

 

MADISON, NJ-Bausch + Lomb announced that the U.S. Food and Drug Administration (FDA) has approved the company’s New Drug Application (NDA) for Prolensa (bromfenac ophthalmic solution) 0.07% prescription eye drop, a once-daily nonsteroidal anti-inflammatory drug (NSAID) for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. Prolensa will be available in 1.6ml and 3ml bottle sizes.

Prolensa provides resolution of inflammation and pain by leveraging the bromfenac molecule in a formulation designed to facilitate ocular penetration. The formulation allows for a lower concentration of bromfenac in a once-daily dosing regimen. Prolensa is a solution that does not require shaking to deliver a consistent dose in each drop.

The efficacy of Prolensa was evaluated in two randomized, double-masked, vehicle-controlled studies of patients undergoing cataract surgery. Each randomized patient received Prolensa or vehicle starting with one drop into the surgical eye on the day prior to and the day of surgery, and for 14 days following surgery. The primary efficacy end point was complete clearing of ocular inflammation (assessed by the summed ocular inflammation score, SOIS, which includes cells and flare) by Day 15. The secondary efficacy end point was the number of subjects that were pain free on Day 1 after surgery.

Results from the pivotal studies demonstrated Prolensa to be superior to vehicle in the treatment of both inflammation and pain following cataract surgery. Twice as many patients as vehicle (46 percent vs 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 8. Nearly four of five patients treated with Prolensa were pain free at Day 1 (78.8 percent vs 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.