ISTA Pharmaceuticals Submits New Drug Application for Xibrom(TM) QD (once-daily)
IRVINE, Calif., Dec. 20 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals,
Inc. (Nasdaq: ISTA), announced today the Company has submitted a New Drug
Application (NDA) to the U.S. Food and Drug Administration (FDA) for
Xibrom(TM) QD (once-daily). The Company is seeking approval for Xibrom QD as
a treatment for inflammation, pain, and photophobia following cataract
surgery.
Xibrom(TM) (bromfenac ophthalmic solution)
Xibrom is a topical non-steroidal anti-inflammatory compound for the
treatment of ocular inflammation and pain. Xibrom, approved in 2005, is the
first and only FDA-approved twice-daily NSAID for inflammation and reduction
of pain following cataract surgery. Xibrom is the fastest growing ophthalmic
product in 2007, according to IMS data. Xibrom, under a different trade name
but identical formulation, was launched in Japan in 2000 by Senju
Pharmaceuticals Co. Ltd. ISTA acquired U.S. marketing rights for Xibrom in
2002 and launched the product in the U.S. in 2005.
ABOUT ISTA PHARMACEUTICALS
ISTA Pharmaceuticals is an ophthalmic pharmaceutical company. ISTA's
products and product candidates addressing the $3.2 billion U.S. prescription
ophthalmic industry include therapies for inflammation, ocular pain, glaucoma,
allergy, and dry eye. The Company currently markets three products and is
developing a strong product pipeline to fuel future growth and market share.
The Company's product development and commercialization strategy is to launch
a new product every 12 to 18 months, thereby continuing its growth to become
the leading niche ophthalmic pharmaceutical company in the U.S. For additional
information regarding ISTA, please visit ISTA Pharmaceuticals' website at
http://www.istavision.com.
SOURCE ISTA Pharmaceuticals, Inc.
Vince Anido, +1-949-788-5311, vanido@istavision.com, or Investors, Lauren
Silvernail, +1-949-788-5302, lsilvernail@istavision.com, both of ISTA
Pharmaceuticals; Media, Justin Jackson, jjackson@burnsmc.com, or Investors,
Juliane Snowden, +1-212-213-0006, jsnowden@burnsmc.com, both of Burns
McClellan, for ISTA Pharmaceuticals
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