PRNewswire
IRVINE, Calif., Jan. 22 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals,
Inc. (Nasdaq: ISTA), today announced positive results from the Company's Phase
IIb clinical study of ecabet sodium, which is being developed as a treatment
for dry eye disease. Patients treated with ecabet sodium achieved a strong
positive trend in the objective sign of Tear Film Break-Up Time (TFBUT) and a
positive trend in the objective sign of quantity of tears produced (Schirmer
Test). In contrast, there were no trends seen in the placebo group for either
objective sign. In addition, there were no trends seen in either group in
subjective symptoms as measured by the Ocular Surface Disease Index (OSDI) or
patient's worst reported symptom. In Phase II tests where observations are
not powered to show statistical significance, strong and positive trends are
used as indicators of potential efficacy in subsequent Phase III studies.
"The Phase IIb results from this environmental study add further support
to our belief that ecabet sodium has the ability to treat signs and symptoms
of dry eye syndrome. Ecabet sodium may provide advantages over other products
used to treat dry eye and those that are in development, as we believe ecabet
sodium not only improves the quality of tears but also increases the quantity
of tears," stated Vicente Anido Jr., Ph.D., President and Chief Executive
Officer of ISTA Pharmaceuticals. "After reviewing the guidance from and our
discussions with the FDA, we believe that by conducting two successful Phase
III environmental clinical trials for improvement in signs and two successful
Phase III controlled chamber clinical trials for the improvement of symptoms,
we should receive marketing approval. In addition, we are expecting results
from a Phase II clinical trial studying the potential of a lower strength of
Xibrom to treat the signs and symptoms of dry eye disease in the first half of
2009. Once this lower strength Xibrom trial is completed, we will make a
decision on which product or products in our dry eye franchise to move into
Phase III trials, which could start as early as 2010."
ISTA's previous two Phase II trials of ecabet, which were conducted in a
controlled environment chamber, demonstrated positive trends in patient's
symptoms (OSDI and patient's worst symptom, both trials) and in the signs of
corneal staining (one trial) and blink rate (both trials). The Company
believes the lack of response to ecabet in symptoms in the most recent trial
is not of concern, in part because the OSDI responses to ecabet sodium were
strong and predictable in the previous Phase II trials. ISTA believes that
given the ability to demonstrate a positive effect on signs in the environment
and on symptoms in the controlled environment chamber, there is now a clear
path forward to Phase III studies and New Drug Application filing for this
product.
Background on ISTA's Recent Phase IIb Study Results
ISTA's Phase IIb trial randomized 144 patients to receive either ecabet
sodium or placebo four times per day for 43 days. The object of the study was
to investigate ecabet sodium's effects on the objective signs of tear
production (Anesthetized and Unanesthetized Schirmer Tests) and tear film
quality (TFBUT) and subjective symptoms (OSDI, patient's worst symptom) in
patients with dry eye disease when administered under normal environmental
conditions.
In the analysis of responders to both ecabet sodium and placebo, results
of the Anesthetized Schirmer Test in the Phase IIb study revealed a strong
trend for ecabet sodium, which approached statistical significance versus
placebo. This result is important because it indicates an effect on basal
tear secretion, which is one of the main factors in the etiology of dry eye
disease. In addition, the percentage of patients who responded to ecabet
sodium was greater than that seen in the trials that led to the approval of
the only currently approved product on the market for dry eye disease.
Further, this trend in increased Schirmer Test score was seen as early as day
22 of treatment and continued to trend upwards through day 43. Adverse events
were uncommon and similar between the treatment and placebo groups, and there
were no serious ocular or systemic adverse events.
Another important finding in this trial was that patients with more severe
disease as measured by the Anesthetized Schirmer Test, TFBUT and specific
staining attributes were more likely to respond to ecabet sodium than placebo.
Thus, in future Phase III trials, these specific attributes can be used for
screening of patients who would be most likely to benefit from treatment with
ecabet sodium.
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 Mitsubishi Tanabe Pharma Corporation (formerly 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 Pharmaceuticals
ISTA Pharmaceuticals is an ophthalmic pharmaceutical company. ISTA's
products and product candidates addressing the $4.7 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 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 related to the anticipated design of future ecabet sodium
studies, the results of future or ongoing studies with lower strength Xibrom,
ISTA's intention to select one or more products to advance to Phase III in
2010, ISTA's belief that ecabet sodium not only improves the quality of tears
but also increases the quantity of tears, ISTA's belief that conducting two
successful Phase III environmental clinical trials for improvement in signs
and two successful Phase III controlled chamber clinical trials for the
improvement of symptoms should lead to marketing approval of ecabet sodium and
ISTA's expectation of becoming the leading niche ophthalmic pharmaceutical
company 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; the uncertain nature of clinical research and
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, 2007, and its most recent Quarterly Report on Form
10-Q for the quarter ended September 30, 2008.
SOURCE: ISTA Pharmaceuticals, Inc.
CONTACT:
Vince Anido, Ph.D., +1-949-788-5311, [email protected];
or
Lauren Silvernail, +1-949-788-5302, [email protected],
both of ISTA
Pharmaceuticals;
or Investors:
Juliane Snowden, [email protected],
or
Media:
Justin Jackson, [email protected],
both of Burns McClellan,
+1-212-213-0006, for ISTA Pharmaceuticals
Web Site: http://www.istavision.com