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news.InSite Vision has announced that the Swedish Medical Products Agency (MPA) concluded that the existing Phase III clinical data for BromSite for the prevention of pain and inflammation in ocular surgery was likely sufficient to support the filing of a Marketing Authorization Application (MAA) with the MPA.
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Prior to the meeting with the MPA on 26 May 2014, InSite Vision had submitted substantial preliminary BromSite information to the Agency including CMC (chemistry, manufacturing, and controls) data, preclinical and clinical data sets and analytical methods.
InSite CEO Timothy Ruane said that the company is very encouraged by its conversations with the MPA, which advised us that the BromSite label could be significantly broader than the existing bromfenac drugs already approved in the EU and that a centralized approval with the European Medicines Agency can be considered.
Following the formal discussion of BromSite, there was an informal discussion of InSite Vision’s blepharititis program, which includes AzaSite Plus and DexaSite. The MPA agreed that InSite Vision can submit a post Phase 3/pre-MAA briefing package using existing clinical data for AzaSite Plus and DexaSite and arrange a meeting with the MPA in the second half of 2014.