Bausch + Lomb, the global eye health company, has received the US Food and Drug Administration (FDA) approval for its New Drug Application (NDA) Prolensa (bromfenac ophthalmic solution) 0.07 per cent prescription eye drop, an innovative 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 powerful and rapid 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. Prolensa is a solution that does not require shaking to deliver a consistent dose in each drop.
Steven M Silverstein, M.D., FACS, founder of Silverstein Eye Centers in Kansas City, Montreal said, “The data show that once-daily dosing with Prolensa provides powerful and rapid control of inflammation and pain following cataract surgery, confirming the potency of this NSAID and the benefits of the new formulation.” He further added, “Prolensa reduces the amount of medication placed on the healing eye while maintaining a high degree of efficacy and ocular comfort.”
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 endpoint 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 endpoint was the number of subjects that were pain free on day one 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 per cent versus 20 per cent) 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 per cent versus 49.5 per cent 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.
Dan Wechsler, executive vice president and president, Bausch + Lomb Global Pharmaceuticals informed that Bausch + Lomb is committed to delivering innovative therapeutic options to eye care professionals and the patients they serve, and the advanced formulation used for Prolensa embodies that commitment. “We look forward to bringing this next evolution of the groundbreaking bromfenac franchise to our customers very soon.”
Bausch + Lomb is solely focused on protecting, enhancing, and restoring people’s eyesight.