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`ISTA Pharmaceuticals Receives FDA Approval for Bromday
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`FDA Approves Bromday
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`ISTA Pharmaceuticals Receives FDA Approval for Bromday
`
`IRVINE, Calif., Oct. 16 /PRNewswireFirstCall/ ISTA Pharmaceuticals, Inc. today announced the U.S.
`Food and Drug Administration (FDA) has approved the Company's supplemental New Drug Application
`(sNDA) for Bromday (bromfenac ophthalmic solution) 0.09% as a oncedaily prescription eye drop for the
`treatment
` of postoperative inflammation and reduction of ocular pain in patients who have undergone
`cataract extraction. ISTA expects to launch Bromday (formerly referred to as XiDay) prior to the end of 2010.
`
`"Bromday is the only oncedaily ophthalmic nonsteroidal antiinflammatory drug (NSAID) for the treatment of
`postoperative inflammation and reduction of ocular pain in patients who have undergone cataract extraction.
`We believe the convenience of a oncedaily eye drop will help with treatment compliance and benefit patients
`recovering from cataract surgery," stated Vicente Anido, Jr., Ph.D., President and Chief Executive Officer of
`ISTA. "Bromday is an important addition to our growing prescription eye and allergy product portfolio .
`Within just a few weeks, our expanded sales force will be ready to promote Bromday to U.S.based
`ophthalmologists, along with Bepreve, our recently launched eye drop for the treatment of itching associated
`with allergic conjunctivitis.
`
`"Since the Bromday approval process required additional clinical investigations beyond those conducted for
`the original approval of Xibrom 0.09%, we are seeking a threeyear exclusivity period under the Drug Price
`Competition and Patent Term Restoration Act, commonly known as the HatchWaxman Act. Bromday
`represents a significant step in extending our successful bromfenacbased product line established when we
`launched Xibrom, our twicedaily NSAID for use following cataract surgery, in 2005. In addition, we are
`evaluating a new formulation and lower concentrations of bromfenac called Remura for the potential
`treatment of dry eye which is now in Phase 3 clinical studies. Beginning in midNovember, we will begin
`detailing Bromday to ophthalmologists; we expect to discontinue the twicedaily Xibrom product in early
`2011."
`
`About Bromday
`Bromday is a oncedaily eye drop formulation of a nonsteroidal antiinflammatory compound for the treatment
`of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract
`extraction. Bromday is approved for dosing oncedaily beginning one day prior to surgery, on the day of
`surgery and continuing for the first 14 days after surgery. Since 2005, ISTA has marketed Xibrom
`(bromfenac ophthalmic solution) 0.09% in the U.S. for twicedaily use for the treatment of postoperative
`inflammation and the reduction of ocular pain in patients who have undergone cataract surgery. ISTA
`acquired U.S. ophthalmic rights to bromfenac in May 2002 under a license from Senju Pharmaceuticals Co.
` share leader in the $335 million U.S. ophthalmic nonsteroidal anti
`Ltd. Xibrom is the 2010 dollar market
`inflammatory market. ISTA reported Xibrom net sales of $81.1 million for the year ended December 31,
`2009, and net sales of $41.4 million in the first six months of 2010, up 22% over the first six months of 2009.
`
`Indications and Usage
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`SENJU EXHIBIT 2188
`LUPIN v. SENJU
`IPR2015-01097
`
`
`
`ISTA Pharmaceuticals Receives FDA Approval for Bromday
`11/16/2015
`Bromday is a nonsteroidal antiinflammatory drug (NSAID) indicated for the treatment of postoperative
`inflammation and reduction of ocular pain in patients who have undergone cataract extraction.
`
`Dosage and Administration
`
`Instill one drop into the affected eye(s) oncedaily beginning 1 day prior to surgery, continued on the day of
`surgery and through the first 14 days postsurgery.
`
`Dosage Forms and Strengths
`
`Topical ophthalmic solution: bromfenac 0.09%
`
`Contraindications
`
`None
`
`Warnings and Precautions
`
`Sulfite Allergic Reactions
`Slow or Delayed Healing
`
`Potential for crosssensitivity
`
`Increased bleeding of ocular tissues
`
`Corneal effects including keratitis
`Contact Lens Wear
`
`Adverse Reactions
`
`The most commonly reported adverse reactions in 27% of patients were abnormal sensation in the eye,
`conjunctival hyperemia and eye irritation (including burning/stinging).
`
`Full prescribing information will be available soon on ISTA Pharmaceuticals' website at
`http://www.istavision.com.
`
`About ISTA Pharmaceuticals
`ISTA Pharmaceuticals, Inc. is the fourth largest and fastest growing branded prescription eye care business
`in the United States, with an expanding focus on allergy therapeutics. ISTA currently markets five products,
`including treatments for ocular inflammation and pain associated with cataract surgery, glaucoma, and ocular
`itching associated with allergic conjunctivitis. The Company's development pipeline contains additional
`candidates in various stages of development to treat dry eye, ocular inflammation and pain, and nasal
`allergies. Headquartered in Irvine, California, the Company generated 2009 revenues of $111 million. For
`additional information about ISTA Pharmaceuticals, please visit the corporate website at
`www.istavision.com.
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`11/16/2015
`ISTA Pharmaceuticals Receives FDA Approval for Bromday
`FORWARDLOOKING STATEMENTS
`
`Any statements contained in this press release that refer to future events or other nonhistorical matters are
`forwardlooking statements. Without limiting the foregoing, but by way of example, statements contained in
`this press release related to the expected launch of Bromday in 2010, ISTA's anticipated devotion of
`resources toward the marketing of Bromday and BEPREVE, ISTA's intention to discontinue marketing and
`selling Xibrom in 2011, the potential exclusivity for Bromday under the Drug Price Competition and Patent
`Term Restoration Act, and the completion of Phase 3 studies for REMURA (bromfenac ophthalmic solution
`for dry eye), are forwardlooking statements. Except as required by law, ISTA disclaims any intent or
`obligation to update any forwardlooking statements. These forwardlooking statements are based on ISTA's
`expectations as of the date of this press release and are subject to risks and uncertainties that could cause
`actual results to differ materially. Important factors that could cause actual results to differ from current
`expectations include, among others, delays and uncertainties related to the FDA or other regulatory agency
`approval or actions and such other risks and uncertainties as detailed from time to time in ISTA's public filings
`with the U.S. Securities and Exchange Commission, including but not limited to ISTA's Annual Report on
`Form 10K for the year ended December 31, 2009, and its Quarterly Report on Forms 10Q for the quarters
`ended March 31 and June 30, 2010.
`
`SOURCE ISTA Pharmaceuticals, Inc.
`
`CONTACT: Investor Relations: Lauren Silvernail, +19497885302, lsilvernail@istavision.com, or Jeanie
`Herbert, +19497893159, jherbert@istavision.com; or Juliane Snowden, Burns McClellan, +1212213
`0006, jsnowden@burnsmc.com; General Media: Justin Jackson, Burns McClellan, +12122130006,
`jjackson@burnsmc.com; Trade Media: Tad Heitmann, BioComm Network, +19494943140,
`theitmann@BioCommNetwork.com
`
`Web Site: http://www.istavision.com
`
`Posted: October 2010
`
`Related Articles:
`ISTA Pharmaceuticals Receives Action Date for FDA Review of OnceDaily XiDay March 9, 2010
`ISTA Pharmaceuticals Submits Supplemental New Drug Application to the FDA for OnceDaily
`XiDay December 23, 2009
`
`Bromday (bromfenac) FDA Approval History
`
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