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ISTA Pharmaceuticals Submits
Supplemental New Drug Application to the FDA for Once-Daily
XiDay™
IRVINE, Calif., Dec 17, 2009 /PRNewswire-FirstCall via COMTEX/
-- ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA), today announced
the Company submitted a supplemental New Drug Application (sNDA)
to the U.S. Food and Drug Administration (FDA) for bromfenac
ophthalmic solution dosed once-daily as a treatment for ocular
inflammation and pain following cataract surgery. ISTA currently
markets Xibrom™ (bromfenac ophthalmic solution) 0.09%, which is
an eye drop labeled for use twice-daily, beginning 24 hours
after cataract surgery. If approved, ISTA plans to market the
once-daily product under the brand name XiDay™.
ISTA filed the XiDay sNDA electronically in eCTD format. Pending
FDA validation of the electronic file in the coming days and
timely acceptance of the filing by the FDA, ISTA expects a
standard review of six months from date of receipt.
Xibrom™ (bromfenac ophthalmic solution)
Xibrom is a topical non-steroidal anti-inflammatory compound for
the treatment of ocular inflammation and pain following cataract
surgery. 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.
Xibrom is the 2009 year-to-date dollar market share leader in
the U.S. ophthalmic non-steroidal anti-inflammatory market. ISTA
reported Xibrom net sales of $55.1 million for the nine-month
period ended September 30, 2009.
Xibrom currently is labeled as an eye drop used twice-daily
beginning 24 hours after cataract surgery. Xibrom has not been
approved by the FDA as a once-daily treatment. ISTA's sNDA
filing requests the Agency approve a change to bromfenac
ophthalmic solution's label to reflect its efficacy as a
once-daily treatment in this patient population.
About ISTA Pharmaceuticals
ISTA Pharmaceuticals is the fourth largest branded ophthalmic
pharmaceutical business in the U.S. ISTA's four marketed
products plus its product candidates include therapies for
inflammation, ocular pain, glaucoma, allergy, and dry eye. The
Company is developing a strong product pipeline to fuel future
growth and market share, 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.
Xibrom™ (bromfenac ophthalmic solution) 0.09%, and XiDay™ are
trademarks of ISTA Pharmaceuticals.
Forward-looking Statements
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 FDA's timely acceptance and approval of XiDay,
ISTA's belief that the FDA will review and take action on XiDay
within six months of filing and ISTA's expectation of becoming
the leading niche ophthalmic pharmaceutical company 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, 2008, and its most recent
Quarterly Report on Form 10-Q for the quarter ended September
30, 2009.
Source
ISTA Pharmaceuticals, Inc.
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