FDA approves BromSite to treat inflammation, prevent pain in cataract surgery
The FDA has approved BromSite to treat postoperative inflammation and prevent ocular pain in patients who undergo cataract surgery, according to a press release from Sun Pharma.
BromSite (bromfenac ophthalmic solution 0.075%) is the first NSAID approved by the FDA to prevent pain and treat inflammation in cataract surgery. The agent was developed by InSite Vision and is the first bromfenac ophthalmic solution formulated in DuraSite, a polymer-based formulation that can be used to improve solubility, absorption, bioavailability and residence time, according to the release.
In two multicenter, randomized, placebo-controlled phase 3 studies, 77% and 82% of patients who received BromSite and 48% and 62% of those who received the vehicle control were pain-free 1 day after surgery; the difference was statistically significant (P < .001). In addition, 57% and 38% of patients who received BromSite and 19% and 22% of those who received the vehicle were free of inflammation 15 days after surgery (P < .001 and P = .035, respectively).
Sun Pharma acquired InSite Vision in November 2015 and plans to commercialize BromSite through Sun Ophthalmics, its newly formed U.S.-based division, in the second half of 2016, according to the release.