|
ISTA Pharmaceuticals Presents Results from Two Phase III
Clinical Trials of Xibrom(TM) QD (Once-daily) Formulation at the
American Academy of Ophthalmology Annual Meeting
IRVINE, Calif., Nov. 12 /PRNewswire-FirstCall/ -- ISTA
Pharmaceuticals, Inc. (Nasdaq: ISTA), presented today results
from the Company's two Phase III clinical trials of Xibrom(TM) (bromfenac
sodium ophthalmic solution) QD (once- daily) formulation, a new
formulation of ISTA's ocular, non-steroidal anti- inflammatory
agent. The multi-center studies evaluated the new once-daily
formulation of Xibrom versus placebo in over 500 patients who
underwent cataract surgery. The highly statistically significant
findings demonstrated Xibrom QD (once-daily) was superior to
placebo (P less than or equal to 0.0001) in achieving both the
primary efficacy endpoint of absence of ocular inflammation 15
days following surgery and the secondary efficacy endpoint of
elimination of ocular pain at day one. In addition, compared to
placebo, bromfenac produced a lower overall incidence of ocular
adverse events. William B. Trattler, M.D. presented the results
during the 2007 Annual Meeting of the American Academy of
Ophthalmology (AAO) being held in New Orleans, Louisiana.
ISTA also announced today a second poster presentation at the
AAO meeting. This study demonstrated the currently marketed
twice-daily formulation of Xibrom was as effective as both
diclofenac sodium 0.1% ophthalmic solution or ketorolac
tromethamine 0.5% ophthalmic solution, each dosed four times
daily, when used for 3 months in the treatment of cystoid
macular edema (CME) following uncomplicated cataract surgery.
Poster Presentations at AAO Meeting:
Monday, November 12th; 12pm - 2pm, Location: Morial Convention
Center, Hall D
Abstract # 0259: Integrated Results from 2 Phase III Clinical
Trials of a Once Daily Bromfenac Ophthalmic Solution for Ocular
Surgery
Contributing authors: William B. Trattler, MD; Peter A. Rapoza,
MD; James H. Peace, MD; Y. Ralph Chu, MD; Thomas R. Walters, MD;
Robert H. Stewart, MD; Ralph Bianca, PhD; James A. Gow, MD;
Timothy R. McNamara, PharmD.
A total of 542 patients were enrolled in two randomized,
double-masked, placebo-controlled studies under the same
protocol at 39 sites in the U.S. Subjects were assigned randomly
to receive either Xibrom once-daily or placebo (n=360) or
(n=182). Dosing began one day before cataract surgery and
continued through post-surgery day 14. Elimination of ocular
pain was assessed at Day 1 and complete absence of ocular
inflammation was assessed on Day 15.
Sunday, November 11th; 2pm - 3:30pm, Location: Morial Convention
Center, Hall D
Abstract: Bromfenac Versus Diclofenac Versus Ketorolac in the
Treatment of Acute Pseudophakic Cystoid Macular Edema
Contributing authors: David S. Rho, MD, Rochelle E. Tractenberg,
PhD, Bruce J. Markovitz, MD, Stephen M. Soll, MD.
In this study, 122 patients with acute CME within 1 year after
uncomplicated cataract surgery were treated for 3 months as
follows: approximately half of the patients with Xibrom twice
daily, and 30 each with either diclofenac or ketorolac four
times daily. Visual acuity was measured with Early Treatment
Diabetic Retinopathy Study (ETDRS) charts. While no significant
difference in ETDRS letters gained was noted between the three
treatment groups, the patients treated with Xibrom recorded the
greatest gain in visual function.
Xibrom(TM) (bromfenac ophthalmic solution)
Xibrom is a topical non-steroidal anti-inflammatory compound for
the treatment of ocular inflammation and pain. Xibrom is the
first and only FDA-approved twice-daily NSAID for inflammation
and pain following cataract surgery. In 2006, Xibrom became the
second highest-prescribed topical NSAID by ophthalmologists on a
dollar basis, 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
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 projected timelines for
filing of a supplemental New Drug Application for Xibrom QD
(once-daily) with the Food and Drug Administration and the
expected approval of ISTA's application, the Company's
expectation patients and physicians will choose Xibrom QD
(once-daily) over other ophthalmic NSAID formulations, 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
http://www.istavision.com
Contact
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 Nicki Kahner, nkahner@burnsmc.com, or
Media, or Justin Jackson, jjackson@burnsmc.com, all of Burns
McClellan for ISTA, +1-212-213-0006
|
