FDA approves first pain preventing NSAID

BromSite, a 0.075% bromfenac ophthalmic solution, is now approved for pain prevention and inflammation reduction post cataract surgery. Current NSAID formulations are indicated only for the reduction of ocular pain and inflammation.

“Today, I am pleased to see BromSite advance from development to market. I am confident there will be significant clinician interest in this new product,” said Dr. Richard L. Lindstrom, MD, founder and attending surgeon of Minnesota Eye Consultants and Adjunct Professor Emeritus at the University of Minnesota Department of Ophthalmology. “As the first NSAID labeled to prevent pain and reduce inflammation post-cataract surgery, BromSite’s approval is timely and will be welcomed by patients and clinicians alike.”

In 2, multi-center, placebo-controlled phase 3 studies, 77% and 82% of patients treated with BromSite reported to be pain-free at 1 day postop, compared to 48% and 52% in the placebo group (P<0.001). Positive results were also seen at the 15-day mark, at which time 57% and 38% of patients who received the active drug were inflammation free, compared to 19% and 22% for the control group (P<0.001 and P=0.035).

Developed by Sun Ophthalmics subsidiary InSite Vision, BromSite is the first bromfenac solution formulated with large molecular weight polymers (DuraSite) to improve the residence time, absorption and bioavailability of the drug in the tear film. According to a 2013 double-masked, randomized study, BromSite (bromfenac 0.075% in DuraSite) achieved 2 times the aqueous humor concentration of Bromday (bromfenac 0.09%) in patients following the same dosing instructions.

 U.S. launch is expected in the second half of 2016.