FDA Approves Eye Drop for Post-Cataract Surgery Patients
04/17/2013 0 Comments
The U.S. Food & Drug Administration has approved Bausch + Lomb's New Drug Application for Prolensa (bromfenac ophthalmic solution) 0.07% prescription eye drop, an innovative once-daily nonsteroidal anti-inflammatory drug for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. Prolensa will be available in 1.6 ml and 3 ml bottles.
According to Bausch + Lomb, Prolensa provides resolution of inflammation and pain by leveraging the unique potency of the bromfenac molecule in a formulation designed to facilitate ocular penetration. The advanced formulation allows for a lower concentration of bromfenac in a once-daily dosing regimen. Additionally, Prolensa does not require shaking to deliver a consistent dose in each drop.
Prolensa's efficacy was evaluated in two randomized, double-masked, vehicle-controlled studies of patients undergoing cataract surgery. Results from the studies demonstrated the eye drop to be superior to the vehicle in the treatment of both inflammation and pain following cataract surgery.