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ISTA Pharmaceuticals Announces Positive
Preliminary Phase 3 Clinical Results to Support sNDA Filing for
Once-Daily Xibrom™ 0.09%
IRVINE, Calif., Aug. 25 /PRNewswire-FirstCall/ -- ISTA
Pharmaceuticals, Inc. (Nasdaq: ISTA), today announced positive
preliminary Phase 3 results from the Company's Xibrom™ (bromfenac
ophthalmic solution) 0.09% QD (once-daily) confirmatory clinical
study. Xibrom 0.09% QD achieved statistical significance in the
study's primary endpoint, the absence of ocular inflammation 15
days following cataract surgery, and the secondary efficacy
endpoint, the elimination of ocular pain one day post surgery.
During the study, no serious ocular or systemic adverse events
occurred, and the safety profile is consistent with ISTA's
currently marketed Xibrom twice-daily formulation.
The confirmatory Phase 3 study was a multi-center, randomized,
double-masked, parallel-group study in 299 patients who
underwent cataract surgery in one eye. Patients were assigned
randomly (1:1) to receive either Xibrom once daily or placebo.
Dosing began one day before cataract surgery and continued for
14 days following surgery. The proportion of patients
experiencing no pain was assessed at Day 1 post surgery, and the
proportion of patients with complete absence of ocular
inflammation was assessed at Day 15 post surgery. Ocular
inflammation was evaluated using a summed ocular inflammation
score (SOIS) and was measured by an assessment of immune cells
in the anterior chamber of the eye ("cells") and cellular debris
("flare"). The secondary efficacy endpoint was evaluated via a
pain score from the Ocular Comfort Grading Assessment recorded
in a diary. Patients also graded their symptoms at each office
visit, which included photophobia, the chief symptomatic
complaint following cataract surgery.
In December 2008, ISTA announced integrated results from two
Phase 3 studies with Xibrom 0.09% QD. Based on the results of
the studies, the U.S. Food and Drug Administration (FDA)
required ISTA to conduct an additional confirmatory study with
Xibrom 0.09% QD. The current study confirms the efficacy and
safety of Xibrom 0.09% QD which was previously demonstrated in
an identical Phase 3 clinical trial in 2008. Once the Company
completes its analysis of the full dataset, ISTA expects to file
a supplemental New Drug Application (sNDA) with the FDA prior to
the end of 2009, seeking approval of the Xibrom 0.09%
formulation for once-daily treatment for the inflammation and
pain following cataract surgery.
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.
According to IMS data, Xibrom is the 2009 dollar market share
leader in the U.S. ophthalmic nonsteroidal anti-inflammatory
market, with net sales of $33.8 million for the six-month period
ended June 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 will request the Agency to approve a change to the drug's
label to reflect Xibrom's efficacy as a once-daily treatment in
this patient population.
About ISTA Pharmaceuticals
ISTA Pharmaceuticals is an ophthalmic pharmaceutical company.
ISTA's products and product candidates addressing the $5.1
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,
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.
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 ISTA's filing of a supplemental New Drug Application
(sNDA) with the FDA for Xibrom QD prior to the end of 2009 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; uncertainties and
risks regarding market acceptance of and demand for ISTA's
approved products; 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 June 30, 2009.
Contacts
Vince Anido, Ph.D., +1-949-788-5311, vanido @istavision.com;
or Lauren Silvernail, +1-949-788-5302,
lsilvernail @istavision.com,
both of ISTA Pharmaceuticals;
or Investors:
Juliane Snowden, jsnowden @burnsmc.com,
or Media:
Justin Jackson, jjackson @burnsmc.com, both of Burns McClellan,
+1-212-213-0006,
for ISTA Pharmaceuticals
Source
ISTA Pharmaceuticals, Inc.
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