InSite Vision Announces the Issuance of Broad U.S. Patent Covering Bromfenac Formulations in DuraSite®
BromSite™, ISV-101 and BromDex™ Product Candidates Will Have Patent Protection through August 2029
ALAMEDA, Calif.--(BUSINESS WIRE)--InSite Vision Incorporated (OTCBB:INSV) today announced that the United States Patent and Trademark Office (USPTO) has issued a U.S. Patent No. 8,778,999 covering Bromfenac Non-Steroidal Ophthalmic Compositions Formulated in DuraSite. The allowed patent contains 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 covered under this patent include: ISV-101 (bromfenac 0.01%-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 the combination of bromfenac and dexamethasone containing products such as BromDex™ (ISV-504). Due to USPTO delays, the patent term was extended by 155 days to provide protection for bromfenac formulations in DuraSite to August 2029.
InSite has successfully completed two Phase 3 clinical trials of BromSite and plans to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) in the second half of 2014. BromSite demonstrated 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) determined 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.
About InSite Vision
InSite Vision is advancing new ophthalmologic products for unmet eye care needs based on its innovative DuraSite® platform technologies. The DuraSite and DuraSite 2 drug delivery systems extend the duration of drug retention on the surface of the eye, thereby reducing the frequency of treatment and improving the efficacy of topical drugs.
The DuraSite platform is currently leveraged in two commercial products for the treatment of bacterial eye infections, AzaSite® (azithromycin ophthalmic solution) 1%, marketed in the U.S. by Akorn Inc.; and Besivance® (besifloxacin ophthalmic suspension) 0.6%, marketed by Bausch + Lomb, a wholly owned subsidiary of Valeant Pharmaceuticals International. InSite Vision is also advancing AzaSite Plus™, a novel ophthalmic therapeutics through Phase 3 clinical studies for the treatment of eye infections, and is preparing two new drug applications (NDA) for the commercial approval by the U.S. Food & Drug Administration (FDA): BromSite™ for the treatment of inflammation and prevention of pain associated with cataract surgery and DexaSite™ for the treatment of blepharitis. For further information on InSite Vision, please visit www.insitevision.com.
This news release contains certain statements of a forward looking nature relating to future events, including the filing of an NDA and MAA for BromSite in the United States and the European Union, respectively; the Company’s current plans to pursue regulatory approval for its product candidates; and the potential indications for the Company’s pipeline drug candidates. Such statements entail a number of risks and uncertainties, including but not limited to: the Company’s ability to obtain substantial additional funding given that its current cash is currently projected to run out in September 2014, that the scope of patent protection for bromfenac may be less than anticipated, that the patent could subsequently be challenged or that others may allege infringement of their patents or technologies, the ability of the Company to file and receive approval for its BromSite NDA and MAA and the timing thereof; the ability of the Company to enter into corporate collaborations for its product candidates; the Company’s ability to expand its product platform; the Company’s ability to compete effectively, either alone or through its partners, with other companies offering competing products or treatments; the Company’s ability to maintain and develop additional collaborations and commercial agreements with corporate partners, its ability to adequately protect its intellectual property and to be free to operate with regard to the intellectual property of others; and determinations by the FDA. Reference is made to the discussion of these and other risk factors detailed in the Company’s filings with the Securities and Exchange Commission, including its annual report on Form 10-K and its quarterly reports on Form 10-Q, under the caption "Risk Factors" and elsewhere in such reports. Any forward-looking statements or projections are based on the limited information currently available to the Company, which is subject to change. Although any such forward-looking statements or projections and the factors influencing them will likely change, InSite Vision undertakes no obligation to update the information. Such information speaks only as of the date of its release. Actual events or results could differ materially and one should not unduly rely on such statements or information nor assume that the information provided in this release is still valid at any later date.
AzaSite® and DuraSite® are registered trademarks
of InSite Vision Incorporated.
AzaSite Plus™, BromSite™, DexaSite™ and BromDex™ are trademarks of InSite Vision Incorporated.
BESIVANCE® is a registered trademark of Bausch + Lomb Incorporated.