InSite Vision announced that the Food and Drug Administration (FDA), in a Day-74 letter, has accepted for review the New Drug Application (NDA) for BromSite (0.075% bromfenac) for the treatment of inflammation and prevention of ocular pain in the post-cataract surgery setting.
The NDA submission was based on two Phase 3 clinical trials that were conducted in more than 500 patients. In its confirmatory Phase 3 trials, BromSite achieved statistically significant superiority in alleviating ocular inflammation and the prevention of pain.
BromSite is an ophthalmic solution that combines low dose (0.075%) bromfenac, an NSAID, with InSite Vision’s DuraSite platform, a synthetic polymer-based formulation that is designed to extend the time of a drug in the eye relative to conventional topical therapies.
For more information call (510) 747–1220 or visit InSiteVision.com.