Gateway drug gets FDA approval: Prolensa

Steve’s breakdown: We call Prolensa a gateway drug because we think you can get through the gateway of the Bausch + Lomb advertising account by congratulating these folks on this FDA approval. Get it?

Prolensa is actually a treatment for inflammation and pain after cataract surgery.

ROCHESTER, NY: Bausch + Lomb, the global eye health company, today 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 percent 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.

“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,” said Steven M. Silverstein , M.D., FACS, founder of Silverstein Eye Centers in Kansas City, MO. “PROLENSA reduces the amount of medication placed on the healing eye while maintaining a high degree ofefficacy 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.

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ACLink: Bausch & Lomb Inc.

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