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ISTA Pharmaceuticals Announces
Physician-Sponsored Clinical Study of Xibrom™ Combination
Therapy with Lucentis®
Presentation is One of Five Posters Scheduled for the 2008
Annual Meeting of the Association for Research in Vision and
Ophthalmology (ARVO)
IRVINE, Calif., Feb. 22 /PRNewswire-FirstCall/ -- ISTA
Pharmaceuticals, Inc. (Nasdaq: ISTA), announced today the
acceptance of an abstract describing the results of a study
using Xibrom™ (bromfenac ophthalmic solution) 0.09% therapy
in combination with Lucentis® (ranibizumab injection) in
patients with age-related macular degeneration (AMD). According
to the abstract, patients who received Xibrom required 1.6 +/-
0.69 injections of Lucentis during the six-month study period,
while patients who received only Lucentis received 4.5 +/- 0.41
injections. Patients with Lucentis alone received significantly
more (2.83 times) injections of ranibizumab (p=0.0002) than
those receiving the combination. There was a numerical trend in
favor of the combination treatment group on improvement in
visual acuity but this difference did not achieve statistical
significance. These data are expected to be presented at the
ARVO 2008 annual meeting, which begins at the end of April.
The study results were gathered from 60 patients receiving
Lucentis therapy for wet AMD. Patients were monitored monthly
using optical coherence tomography (OCT) and fluorescein
angiography. When leakage from vessels was detected, patients
were re-injected with Lucentis. 30 patients received Xibrom
dosed twice daily in addition to the Lucentis injection, and
their results were compared to 30 patients who received Lucentis
only. There were no adverse events associated with the extended
topical administration of bromfenac. The study was designed as a
retrospective case control series.
The clinical findings will be presented on Sunday April 27, 2008
from 11 am - to 12:45 pm by Calvin A. Grant, M.D., author of the
study, in a poster (#A531) titled, "Combination Therapy:
Lucentis (ranibizumab injection) and Xibrom (bromfenac
ophthalmic solution) 0.09% in the Treatment of CNV Membrane
Secondary to AMD". The study was supported by an unrestricted
research grant from ISTA Pharmaceuticals. The full abstract is
available at
www.arvo.org.
"We are very excited about these preliminary results and look
forward to exploring this effect further," stated Timothy R.
McNamara, Pharm.D., Vice President, Clinical Research and
Medical Affairs of ISTA. "ISTA intends to initiate additional
studies to confirm these findings and explore the potential to
enhance patient safety and response in wet AMD therapy."
Additional Poster Presentations scheduled for the 2008 ARVO
Meeting, which will be held at the Greater Fort
Lauderdale/Broward County Convention Center:
Thursday, May 1st; 10:45 am - 12:30 pm; Poster # A593: Efficacy
of Bromfenac Ophthalmic Solution Administered Once Daily for
Ocular Inflammation and Pain Associated With Cataract Surgery;
Steven M. Silverstein, M.D., et al
Tuesday, Apr 29th; 8:30 am - 10:15 am; Poster # A486: The
Incidence of Macular Edema from Two Integrated Phase III
Clinical Trials of Bromfenac Ophthalmic Solution Administered
Once Daily for Cataract Surgery; Thomas R. Walters, M.D., et al
Wednesday, April 30th; 3:00 pm - 4:45 pm; Poster # A548: Effects
of Bromfenac Sodium on Acute and Chronic Uveitis in Rabbits;
Takahiro Ogawa, Ph.D., et al
Sunday, April 27th; 8:30 am - 10:15 am; Poster #D946: Evaluation
of Aqueous Humor Concentrations of Istalol® and Betimol®
following Ocular Instillation into the Eyes of New Zealand White
Rabbits; George A. Baklayan, et al
About Xibrom™ (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 was 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 Istalol®
Istalol is a once-daily, topical solution of timolol, a
beta-blocking agent for the treatment of glaucoma. ISTA holds
exclusive marketing rights to Istalol in the United States under
license from Senju Pharmaceutical Co., Ltd., which developed the
product in Japan.
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.
Forward-Looking Statements
Any statements contained in this press release referring 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
concerning prospects related to the presentation of data at the
ARVO 2008 annual meeting, ISTA initiating further studies on the
combination use of Xibrom and Lucentis, and ISTA's goals of
bringing a new product to market every 12 to 18 months and
becoming the leading niche ophthalmic pharmaceutical company in
the U.S., 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: the inherent uncertainty
associated with financial projections and estimates, timely and
successful implementation of ISTA's strategic initiatives;
delays and uncertainties related to ISTA's research and
development programs (including without limitation the
difficulty of predicting the timing or outcome of bepotastine
product development efforts); the timing, scope, and outcome of
FDA or other regulatory agency approval or actions;
uncertainties and risks regarding market acceptance of and
demand for ISTA's approved products; the impact of competitive
technologies, products, and pricing; uncertainties and risks
related to ISTA's ability to properly manage its growth;
uncertainties and risks related to the continued availability of
third-party sourced products and raw materials on commercially
reasonable terms, or at all; uncertainties and risks related to
successful compliance with FDA and/or other governmental
regulations applicable to ISTA's facilities, products, and/or
business; uncertainties and risks related to the scope,
validity, and enforceability of patents related to ISTA's
products and technologies and the impact of patents and other
intellectual property rights held by third parties; 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, 2006, and its
Quarterly Reports on Form 10-Q for the quarters ended March 31,
2007, June 30, 2007, and September 30, 2007.
SOURCE
ISTA Pharmaceuticals, Inc.
-0- 02/22/2008
CONTACT
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/
/Web site:
http://www.istavision.com
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