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news.InSite Vision Incorporated (INSV) has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for Bromfenac Non-Steroidal Ophthalmic Compositions Formulated in DuraSite.
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The allowed patent claims contain both composition and method of treatment claims that will broadly cover all of InSite’s bromfenac product candidates, including BromSite ((bromfenac 0.075%) ophthalmic solution formulated in DuraSite, ISV-303) for the treatment of inflammation and prevention of pain post cataract surgery.
Additional bromfenac-containing products in InSite’s pipeline that will be covered under this patent include: ISV-101 (bromfenac (0.01% to 0.04%) ophthalmic solution formulated in DuraSite) for the treatment of dry eye disease, back-of-the eye BromSite indications, such as the prevention of cystoid macular edema (CME), as well as bromfenac and dexamethasone containing products such as BromDex (ISV-504). The patent is expected to provide protection for bromfenac formulations in DuraSite to 2029.
"The broad patent allowance granted to our bromfenac in DuraSite product candidates provides substantial protections and reduces risks, particularly as we seek to file for regulatory approvals of BromSite," said Timothy Ruane, Chief Executive Officer of InSite Vision.
"BromSite has demonstrated superior ocular penetration in preclinical studies and clinical efficacy in two Phase 3 post cataract clinical studies. We are preparing for filing a New Drug Application with the FDA later this year and subsequently a Marketing Authorization Application in Europe. This patent allowance provides protection for many years to come and eliminates an issue of potential concern for prospective commercial partners in the United States and Europe."
InSite has successfully completed two Phase 3 clinical trials of BromSite and plans to file a New Drug Application with the U.S. Food and Drug Administration (FDA) in the second half of 2014.
BromSite achieved statistically significant improvements versus vehicle across the primary and secondary endpoints of alleviating ocular inflammation, post-surgical reduction in pain and reduction in inflammatory flare in InSite’s pivotal clinical studies.
InSite Vision recently announced that the Swedish Medical Products Agency (MPA) concluded that the existing Phase 3 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. InSite plans to pursue European regulatory approvals of BromSite following the submission of its U.S. NDA.