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news.The US Food and Drug Administration (FDA) has accepted for review InSite Vision's new drug application (NDA) for BromSite (0.075% bromfenac) to treat inflammation and prevention of ocular pain in the post-cataract surgery setting.
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The agency has assigned a Prescription Drug User Fee Act (PDUFA) action date of 10 April 2016 for BromSite, which has a long patent life extending to August 2029.
BromSite is a combination of low dose (0.075%) of the non-steroidal anti-inflammatory drug (NSAID) bromfenac with InSite’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.
InSite Vision chief executive officer Timothy Ruane said: "We have established an excellent working relationship with the FDA in identifying clear endpoints and study protocols for our BromSite clinical trial programs and in verifying the efficacy of BromSite in providing relief of inflammation and prevention of pain following cataract surgery.
"The FDA’s notification letter is an important milestone for the BromSite NDA and, importantly, satisfies a condition of our merger agreement with QLT Inc."
In its confirmatory Phase III trials, BromSite achieved statistically significant superiority to vehicle in alleviating ocular inflammation and the prevention of pain.
The company noted that in such trials, BromSite was well tolerated with no significant safety concerns or drug-related serious adverse events reported.
The NDA submission was based on two Phase III clinical trials that were conducted in more 500 patients.