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InSite Vision Named in BromSite Patent Lawsuit; Company Believes Lawsuit Is Without MeritInSite Vision Inc. (OTCBB: INSV) today announced that Johnson Matthey Pharmaceutical Materials, Inc. (Johnson Matthey) has filed a patent lawsuit in the United States District Court for the District of Delaware in connection with activities relating to InSite Vision's New Drug Application (NDA) seeking commercial approval from the U.S. Food and Drug Administration (FDA) for BromSite™ (0.075% bromfenac) for the treatment of inflammation and prevention of pain associated with cataract surgery. While implicitly acknowledging that InSite Vision has not infringed on the patents held by Johnson Matthey, the lawsuit nevertheless is seeking a declaration from the court that when InSite Vision commercializes BromSite it will infringe on the claims of one or more patents of Johnson Matthey and asks for an injunction against commercialization. InSite Vision intends to aggressively contest the allegations including seeking a dismissal of the complaint as a judicially premature lawsuit. "The company has consulted outside patent counsel, and having reviewed the assertions relating to this lawsuit in great detail, believes the allegations are entirely without merit," said Tim Ruane, InSite Vision's Chief Executive Officer. About InSite Vision InSite Vision is advancing new specialty ophthalmologic products for treatment of diseases affecting the front and back of the eye. The company has two commercial products based on its innovative DuraSite® platform approved 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 has a proprietary portfolio of clinical-stage product candidates, and has filed a NDA for BromSite™ (0.075% bromfenac) for the treatment of inflammation and prevention of pain associated with cataract surgery. InSite Vision currently plans to file an NDA with the FDA in 2017 for the commercial approval by the U.S. Food and Drug Administration (FDA) of DexaSite™ for the treatment of blepharitis. InSite Vision's AzaSite Plus™ is advancing through Phase 3 clinical studies for the treatment of eye infections, and ISV-101 is in Phase 1/2 clinical development for dry-eye disease and inflammation. For further information on InSite Vision, please visit www.insitevision.com. Cautionary Statements Related to Forward-Looking Statements Statements in this document that are not strictly historical, including statements regarding InSite's intention to aggressively contest the allegations contained in the Johnson Matthey patent suit, its intentions regarding same, the potential outcome of such suit, InSite's clinical and regulatory plans, including its expectation of filing an NDA for DexaSite for the treatment of blepharitis ("DexaSite NDA") in 2017, and other statements contained herein may be "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995, and involve a number of risks and uncertainties. There are a number of important factors that could cause actual events to differ materially from those suggested or indicated by such forward-looking statements and you should not place undue reliance on any such forward-looking statements. These factors include risks and uncertainties related to, among other things: that InSite's plans with respect to contesting such suit may change; the outcome of any litigation, including the Johnson Matthey patent suit, are inherently unpredictable and the outcome is uncertain; general economic conditions and conditions affecting the industries in which InSite Vision operates; InSite Vision's and QLT's ability to satisfy conditions in the QLT merger agreement and consummate a merger in the anticipated timeline or at all; and InSite's ability to file the DexaSite NDA in a timely manner or at all. Additional information regarding the factors that may cause actual results to differ materially from these forward-looking statements is available in InSite Vision's SEC (News - Alert) filings, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2014 and Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2015 under the caption "Risk Factors" and elsewhere in such reports. The forward-looking statements made herein speak only as of the date hereof and neither InSite Vision nor any of its affiliates assumes any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law.
AzaSite®, DuraSite® and DuraSite® 2 are registered trademarks of InSite
Vision Incorporated.
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