The Food and Drug Administration (FDA) has approved a New Drug Application (NDA) for BromSite (bromfenac ophthalmic solution; InSite Vision) for the treatment of postoperative inflammation and prevention of ocular pain in patients undergoing cataract surgery.
The NDA was accepted by the FDA in August 2015 and its submission was based on data from two Phase 3 studies conducted in over 500 patients. BromSite demonstrated statistically significant superiority in alleviating ocular inflammation and prevention of ocular pain. InSite Vision’s DuraSite platform is a synthetic polymer-based formulation that is designed to extend the time of a drug relative to conventional topical therapies.
BromSite contains bromfenac, a non-steroidal anti-inflammatory drug (NSAID). The mechanism of its action is thought to be due to its ability to block prostaglandin synthesis by inhibiting cyclooxygenase (COX) 1 and 2. Prostaglandins have been shown in many animal models to be mediators of certain kinds of intraocular inflammation.
BromSite ophthalmic solution will be available as a 0.075% strength.
For more information call (510) 865-8800 or visit InSiteVision.com.