SOURCE: ISTA Pharmaceuticals

March 04, 2011 07:30 ET

ISTA Pharmaceuticals Files Citizen Petition (CP) With U.S. Food and Drug Administration

CP Requests the FDA Not Approve Generics to Bromfenac Before October 2013

IRVINE, CA--(Marketwire - March 4, 2011) - ISTA Pharmaceuticals, Inc. (NASDAQ: ISTA), announced it filed a Citizen Petition (CP) with the U.S. Food and Drug Administration (FDA) on March 1, 2011. The CP requests the FDA refrain from granting tentative or final approval of any abbreviated new drug application (ANDA) for bromfenac sodium ophthalmic solution 0.09% that utilizes the labeling for discontinued XIBROM (bromfenac ophthalmic solution)® 0.09% or omits any portion of the BROMDAY label relating to the once-per-day dosing. The FDA has acknowledged publicly there are potential safety concerns related to the use of the entire class of ophthalmic nonsteroidal anti-inflammatory drugs (NSAIDs), and patients receiving these compounds post cataract surgery should receive only the lowest effective dose. ISTA filed the CP based upon its head-to-head study between BROMDAY™ (bromfenac sodium ophthalmic solution 0.09%) and bromfenac sodium 0.18%, both dosed once daily (QD), which showed BROMDAY is the lowest-effective dose of this formulation of bromfenac ophthalmic solution for treating postoperative inflammation and reduction in ocular pain post cataract surgery. 

XIBROM was approved in 2005 as a topical NSAID for ophthalmic use after cataract surgery. XIBROM's dosing regimen consisted of two drops per day (BID) for two weeks post surgery (patients received a total of 28 drops). ISTA discontinued shipments of XIBROM on February 28, 2011.

On October 16, 2010, FDA approved ISTA's supplemental new drug application (sNDA) for BROMDAY (bromfenac sodium ophthalmic solution 0.09%) which changed the labeling for the drug to be dosed at one drop the day before surgery, one drop on the day of surgery, and one drop QD for the following two weeks (patients receive a total of 16 drops), based upon the clinical investigations conducted by ISTA that demonstrated QD dosing is the lowest effective dose of this formulation of bromfenac ophthalmic solution for use in connection with cataract surgery. In addition, the FDA granted the product name change to BROMDAY to emphasize the QD dosing and granted the product three years of exclusivity for the clinical studies that were required for the change in dosing. 

The FDA is required to respond within 180 days of receipt of the CP.

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 four 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 2010 revenues of $157 million. For additional information about ISTA Pharmaceuticals, please visit the corporate website at www.istavision.com.

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

Full prescribing information for BROMDAY is available on ISTA Pharmaceuticals' website at http://www.istavision.com/pdf/BROMDAYPI101008.pdf

Full prescribing information for XIBROM is available on FDA's website at http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021664s010lbl.pdf

FORWARD-LOOKING STATEMENTS

Any statements contained in this press release that refer to future events or other non-historical matters 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 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 10-K for the year ended December 31, 2010.

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