SOURCE: ISTA Pharmaceuticals

ISTA Pharmaceuticals

February 08, 2011 07:30 ET

ISTA Pharmaceuticals Announces XIBROM™ Shipments to Wholesalers to End on February 28, 2011

BROMDAY™ Launch On Track -- Capturing 46% of Weekly New Prescriptions in the Bromfenac Franchise by the End of January

IRVINE, CA--(Marketwire - February 8, 2011) - ISTA Pharmaceuticals, Inc. (NASDAQ: ISTA), today announced that due to the rapid adoption of BROMDAY™ (bromfenac ophthalmic solution) 0.09%, the first and only once-daily non-steroidal anti-inflammatory (NSAID) prescription eye drop for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract extraction, the company will stop selling twice-daily XIBROM (bromfenac ophthalmic solution)® 0.09%. ISTA no longer plans to supply XIBROM to pharmaceutical wholesalers after February 28, 2011. For approximately 2-3 weeks thereafter, there will be a limited supply of XIBROM available at wholesalers and pharmacies to fill remaining XIBROM prescriptions. ISTA anticipates wholesalers will continue to sell XIBROM to pharmacies until their inventory is depleted.

As of Fall of 2010, according to data from IMS, twice-daily XIBROM (bromfenac ophthalmic solution)® 0.09% had become the most prescribed branded ocular NSAID in the U.S. market for use following cataract surgery. Last October, ISTA received U.S. Food and Drug Administration (FDA) approval for BROMDAY™, a once-daily formulation of bromfenac. BROMDAY has been granted three years of marketing exclusivity as provided under the Drug Price Competition and Patent Term Restoration Act, commonly known as the Hatch-Waxman Act. Under the Hatch-Waxman Act, the FDA may not approve an Abbreviated New Drug Application for a generic version of BROMDAY until October 2013. ISTA launched BROMDAY at the end of November 2010 and, since that time, has focused most of the sales team's efforts on converting physicians who prescribed XIBROM to prescribing BROMDAY.

"The transition to BROMDAY has been swift. As of the last week in January, 46% of the XIBROM new prescriptions have been converted over to BROMDAY, according to weekly prescription data supplied by IMS," stated Vicente Anido, Jr., PhD, President and Chief Executive Officer of ISTA Pharmaceuticals. "Having the first and only once-a-day NSAID for postoperative inflammation and reduction of ocular pain in patients who have undergone cataract extraction has proven to be a major differentiation in the eyes of our customers and their patients. We look forward to gaining even wider acceptance of BROMDAY throughout the prescribing ophthalmic community in the years to come."

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 post-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

BROMDAY™ (bromfenac ophthalmic solution) 0.09% and XIBROM (bromfenac ophthalmic solution)® 0.09%, are trademarks of ISTA Pharmaceuticals, Inc.

Any statements contained in this press release that refer to future events or other non-historical matters are forward-looking statements. Without limiting the foregoing, but by way of example, statements contained in this press release related to the end of shipments of XIBROM, supplies of XIBROM, inventories of XIBROM and future acceptance of BROMDAY are forward-looking statements. Except as required by law, ISTA disclaims any intent or obligation to update any forward-looking statements. These forward-looking 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 are 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 10-K for the year ended December 31, 2009, and its Quarterly Report on Forms 10-Q for the quarters ended March 31, June 30 and September 30, 2010.

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