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`ISTA Pharmaceuticals Receives FDA Approval for BROMDAY™ IRVINE, Calif., Oct. 16 /PRNewswireFirstCall/
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`ISTA Pharmaceuticals Receives FDA Approval for
`BROMDAY™
` First and Only OnceDaily Eye Drop for the Treatment of Postoperative Inflammation and Reduction of Ocular Pain in
`Patients Who Have Undergone Cataract Extraction
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`IRVINE, Calif., Oct. 16 /PRNewswireFirstCall/ ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA (http://studio
`5.financialcontent.com/prnews?Page=Quote&Ticker=ISTA)), 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.
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`"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."
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`ISTA Pharmaceuticals Receives FDA Approval for BROMDAY™ IRVINE, Calif., Oct. 16 /PRNewswireFirstCall/
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`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. Ltd. XIBROM is the 2010
`dollar market share leader in the $335 million U.S. ophthalmic nonsteroidal antiinflammatory 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.
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`INDICATIONS AND USAGE
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`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.
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`DOSAGE AND ADMINISTRATION
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`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.
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`DOSAGE FORMS AND STRENGTHS
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`Topical ophthalmic solution: bromfenac 0.09%
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`CONTRAINDICATIONS
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`None
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`WARNINGS AND PRECAUTIONS
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`Sulfite Allergic Reactions
`Slow or Delayed Healing
`Potential for crosssensitivity
`Increased bleeding of ocular tissues
`Corneal effects including keratitis
`Contact Lens Wear
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`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).
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`Full prescribing information will be available soon on ISTA Pharmaceuticals' website at
`http://www.istavision.com (http://www.istavision.com/).
`ABOUT ISTA PHARMACEUTICALS
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`ISTA Pharmaceuticals Receives FDA Approval for BROMDAY™ IRVINE, Calif., Oct. 16 /PRNewswireFirstCall/
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`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
`(http://www.istavision.com/).
`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.
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`SOURCE ISTA Pharmaceuticals, Inc.
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`RELATED LINKS
`http://www.istavision.com (http://www.istavision.com)
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