`Press release, dated March 28, 2005.
`EX99.2 3 dex992.htm PRESS RELEASE, DATED MARCH 28, 2005.
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`Exhibit 99.2
`
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`Press Release
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`ISTA Pharmaceuticals Receives FDA Approval for Xibrom(TM) for the Treatment of Ocular Inflammation Following
`Cataract Surgery
`Monday March 28, 7:30 am ET
`
`Source: ISTA Pharmaceuticals, Inc.
`
`
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` Xibrom will be ISTA’s Third Product Launched in the U.S. Market
` IRVINE, Calif., March 28 /PRNewswireFirstCall/ — ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA News) today announced that
`the U.S. Food & Drug Administration (FDA) has approved the New Drug Application (NDA) for Xibrom(TM) (bromfenac
`ophthalmic solution) 0.09% for the treatment of ocular inflammation following cataract surgery. ISTA expects to launch
`Xibrom(TM), a topical, twicedaily, nonsteroidal antiinflammatory solution (NSAID), during the second quarter of 2005,
`after securing commercial quantities of the product from its manufacturer and completing the further expansion of its sales
`force.
`
`Eric Donnenfeld, M.D., Associate Professor of Ophthalmology, New York University Medical Center, New York and an
`investigator in the Xibrom Phase III clinical trials, commented, “Xibrom is the first twicedaily ophthalmic NSAID to be
`approved in the United States. All other ophthalmic NSAIDS are dosed four times daily. Xibrom represents an advance for
`ophthalmic care because of the improved patient compliance and its early onset of action, and I am pleased that patients will
`have this new treatment option.”
`
`Vicente Anido, Jr., Ph.D., President and Chief Executive Officer of ISTA stated, “We are excited to receive FDA approval of
`our third commercial product and anticipate launching Xibrom during the second quarter of 2005. We recently completed the
`interim expansion of our sales force which is now promoting Istalol(TM) and Vitrase®. With the Xibrom approval, we plan on
`hiring additional sales representatives in order to reach approximately 10,000 ophthalmologists in the U.S.”
`
`There will be a conference call today with ISTA management at 10:30 a.m. EDT to discuss the approval of Xibrom in further
`detail. If you would like to participate in the call, please dial (800) 6650430 from the United States or Canada or (913) 981
`5591 from outside North America. A playback of this call will be available today for 24 hours and may be accessed by
`dialing (888) 2031112 from the United States or Canada or (719) 4570820 from outside North America. The rebroadcast
`access code is 3204174. In addition, this conference call will be webcast live and subsequently archived on ISTA’s website at
`http://www.istavision.com.
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`ABOUT XIBROM AND THE U.S. OPHTHALMIC ANTIINFLAMMATORY MARKET
` Xibrom (bromfenac ophthalmic solution) 0.09% is a sterile, topical, nonsteroidal antiinflammatory compound for the
`treatment of ocular inflammation following cataract surgery. Senju Pharmaceuticals Co. Ltd. has marketed this product in
`Japan since 2000. ISTA acquired U.S. marketing rights for Xibrom in May 2002 under a license from Senju. ISTA completed
`two pivotal Phase III clinical studies of Xibrom in the United States. In these studies involving 527 patients, a statistically
`significant proportion of patients treated with Xibrom achieved treatment success, defined as the complete absence of ocular
`inflammation, compared to those patients who received placebo. This effect was evident in the Xibrom group as early as Day
`3 following initiation of treatment. ISTA filed its NDA for Xibrom with the FDA in May 2004.
`
`According to company estimates and data compiled by IMS Health, the U.S. ophthalmic antiinflammatory market,
`consisting of steroids, NSAIDS and other related products, is approximately $250 million per year.
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`Press release, dated March 28, 2005.
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`ABOUT ISTA
` ISTA is a specialty pharmaceutical company focused on the development and commercialization of unique and uniquely
`improved ophthalmic products. ISTA’s products and product candidates seek to address serious diseases and conditions of
`the eye such as dry eye, vitreous hemorrhage, diabetic retinopathy, hyphema, glaucoma and inflammation. Building on this
`pipeline, ISTA’s goal is to continue its growth as a specialty pharmaceutical company by acquiring complementary products,
`either already marketed or in latestage development. For additional information regarding ISTA, please visit ISTA
`Pharmaceuticals’ Website at http://www.istavision.com.
`
`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 regarding the
`timing of our expected commercial launch of Xibrom, our receipt of Xibrom launch quantities, or our sales force expansion
`plans are forwardlooking statements. ISTA disclaims any intent or obligation to update any forwardlooking statements.
`Such 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: risks and uncertainties related to the timing, scope and outcome of FDA and other
`governmental agency actions and decisions; uncertainties and risks regarding market acceptance of Xibrom, including but
`not limited to the impact of competitive products and pricing; uncertainties and risks related to ISTA’s ability to continue to
`sufficiently develop and expand its sales, marketing and distribution capabilities and properly manage its growth;
`uncertainties and risks related to the availability on a timely basis of third party sourced products (including Xibrom) on
`commercially reasonable terms; uncertainties and risks related to the scope, validity and enforceability of patents related to
`ISTA’s products and technologies and the impact of patents and other intellectual property rights held by third parties; and
`such 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, 2004.
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