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.
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
istavision.
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.
ISTA Pharmaceuticals, Inc.
istavision