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ISTA Pharmaceuticals Receives FDA Approval for BROMDAY™
Date:10/16/2010

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 mid-November, we will begin detailing BROMDAY to ophthalmologists; we expect to discontinue the twice-daily XIBROM product in early 2011."

ABOUT BROMDAY

BROMDAY is a once-daily eye drop formulation of a nonsteroidal anti-inflammatory compound for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract extraction.  BROMDAY is approved for dosing once-daily 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 twice-daily 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 anti-inflammatory 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.

INDICATIONS AND USAGE

BROMDAY is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract extraction.

DOSAGE AND ADMINISTRATION

Instill one drop into the affected eye(s) once-daily beginning 1 day prior to surgery, continued on the day of surgery and through the first 14 days post-surgery.  

DOSAGE FORMS AND STRENGTHS

Topical ophthalmic solution:  bromfenac 0.09%

CONTRAINDICATIONS

None

WARNINGS AND PRECA
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SOURCE ISTA Pharmaceuticals, Inc.
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