- Pending Final Analysis of the Results, ISTA Plans to Initiate Phase III
Studies in Dry Eye in 2008 -
IRVINE, Calif., May 31 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals,
Inc. (Nasdaq: ISTA), today announced positive results from the preliminary
analysis of the Company's Phase IIb clinical study of ecabet sodium, which is
being developed as a treatment for dry eye syndrome. Patients in the ecabet
sodium group achieved a strong trend in the objective sign of blink rate. In
addition, patients in the ecabet sodium group reported a strong trend in the
Ocular Symptom Disease Index (OSDI) and a positive trend in the subjective
assessment of patients' most bothersome symptom. Strong and positive trends
are used to confirm observations from previous clinical ecabet sodium studies
and to serve as indicators of potential efficacy endpoints in Phase III
studies. While ISTA's Phase IIb study was not powered to show statistical
significance, ecabet sodium did achieve statistical significance in the OSDI
assessment. There were no reports of serious ocular adverse events compared
with placebo. Further analyses of the Phase IIb study results are ongoing.
"We are very encouraged by the Phase IIb study's preliminary results, as
they support our belief that ecabet has the ability to treat signs and
symptoms of dry eye syndrome," stated Vicente Anido, Jr., Ph.D., President and
Chief Executive Officer of ISTA. "Our key objectives for this study were to
validate our protocol and to screen out non-responders. We were successful in
doing both. In addition, we showed positive trending in one sign and one
symptom, plus achieved statistical significance in a second symptom, all in a
single study. Ecabet sodium may provide advantages over other dry eye
products and product candidates, as we believe the drug not only improves the
quality of tears by enhancing mucin production, but may increase the quantity
of tears produced. Although not a predetermined endpoint in this study, 14
percent of patients in the treatment group reported increases in the quantity
of tears produced, as compared to only 1.8 percent in the placebo group. We
are continuing our analyses of both of our Phase II clinical studies to
identify the signs and symptoms to evaluate in Phase III testing. Upon
completion of the analyses, we will request a meeting with the Food and Drug
Administration to discuss its recommended clinical path in order to bring this
novel treatment to patients suffering from dry eye syndrome. At this time, we
anticipate beginning Phase III studies in 2008."
A total of 112 patients were assigned randomly to receive either ecabet
sodium or placebo four times a day for 90 days. There were four primary
efficacy endpoints: two objective signs (blink rate and corneal staining) and
two subjective symptoms (the patient's most bothersome symptom and the
patient's response to the Ocular Surface Disease Index (OSDI)). Patients were
evaluated in a controlled adverse environment ("dry eye chamber") twice during
the study, once on Day 1 and once on Day 91. The objective signs were
measured pre- and post-exposure to the dry eye chamber on Day 91. The
subjective symptoms were measured following exposure to the dry eye chamber on
both Day 1 and Day 91. To date, the FDA has considered improvement, as
measured in Phase III studies, in one sign and one symptom to be acceptable
for approval of a prescription dry eye product.
ISTA will host a conference call with a simultaneous webcast tomorrow,
Friday, June 1, 2007, at 11:00 AM Eastern Time to discuss today's announcement
regarding the ecabet sodium Phase IIb study preliminary results and other
recent product and commercial developments. To access the live conference
call, U.S. and Canadian participants may dial 866-356-4281; international
participants may dial 617-597-5395. The access code for the live call is
93323302. To access the 24-hour audio replay, U.S. and Canadian participants
may dial 888-286-8010; international participants may dial 617-801-6888. The
access code for the replay is 43054090. This conference call will also be
webcast live and archived on ISTA's website for 30 days at
http://www.istavision.com.
About Ecabet Sodium
ISTA acquired U.S. rights to ecabet sodium for the treatment of dry eye
syndrome from Senju Pharmaceuticals Co., Ltd., in November of 2004. Ecabet
sodium is already marketed in Japan as an oral agent for gastric ulcers and
gastritis by Tanabe Seiyaku Co., Ltd as an originator of ecabet sodium.
Ecabet sodium represents a new class of molecules that increase the
quantity of mucin produced by conjunctival goblet cells and corneal epithelia.
Mucin is a glycoprotein component of tear film that lubricates while retarding
moisture loss from tear evaporation.
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, dry eye, and vitreous hemorrhage. 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.
Statements contained in this press release that refer to future events or
other non-historical matters are forward-looking statements. For example, and
without limiting the foregoing, statements in this press release related to
the prospects and timing of further development of ecabet sodium (including
but not limited to statements that ISTA will complete its analysis and confirm
its preliminary Phase IIb findings, meet with the FDA, and initiate a Phase
III study with respect to ecabet sodium during 2008), the potential of ecabet
sodium to treat dry eye syndrome and its potential advantages over other
currently marketed dry eye products, ISTA's statements about potential future
objective endpoints for Phase III studies 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. Such 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 risk that full analysis of the Phase IIb data or
further testing of ecabet sodium, will not reflect the preliminary Phase IIb
results, or support any or all of the conclusions provided in this press
release; delays, risks and uncertainties related to ISTA's ecabet sodium
development program (including the difficulty of predicting the timing or
outcome of ISTA's product development efforts and the FDA or other
governmental agency approval or actions); uncertainties and risks regarding
market acceptance of ISTA's approved products and the impact of competitive
products and pricing; risks and uncertainties 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 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 ISTA's Quarterly Report on Form 10-Q for
the quarter ended March 31, 2007.
SOURCE ISTA Pharmaceuticals, Inc.
-0- 05/31/2007
/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; Investors: Juliane Snowden, jsnowden@burnsmc.com, or Nicki
Kahner, nkahner@burnsmc.com; Media: Jason Farber, jfarber@burnsmc.com, or
Kristin Faucette, kfaucette@burnsmc.com, all of Burns McClellan,
+1-212-213-0006, for ISTA Pharmaceuticals/
/Website: http://www.istavision.com /
(ISTA)
CO: ISTA Pharmaceuticals, Inc.
ST: California
IN: MTC HEA
SU: SVY CCA
AL-XX
-- NYTH112 --
7732 05/31/2007 16:30 EDT http://www.prnewswire.com
