ISTA
Pharmaceuticals, Inc. (Nasdaq: ISTA), announced positive results from
the preliminary analysis of its second and final Bepreve(TM) (bepotastine
ophthalmic solution) Phase III clinical study. The U.S. multi-center
conjunctival allergen challenge (CAC) study evaluated the onset and
duration of effect of two Bepreve concentrations in 130 patients with a
history of ocular allergies. Both concentrations demonstrated highly
statistically significant reductions in the primary study endpoint of
ocular itching. In addition, both concentrations produced highly
statistically significant effects on the rapidity of response and in the
secondary endpoints measuring additional signs and symptoms of ocular
allergy, as well as improvement in total nasal symptoms. There were no
serious ocular adverse events reported in patients dosed with Bepreve.
The Phase III study was a multi-center, double-masked,
placebo-controlled study. It was designed to evaluate the onset and
duration of effect of Bepreve in two concentrations and in two dosing
schedules, once-daily and twice-daily. Of the 130 patients enrolled, 117
completed the study. Patients were randomized 1:1:1 to receive one of two
concentrations of Bepreve. They were evaluated on 3 separate visits for
their response to the dose administered, which would allow for the
determination of the time to onset, response at 8 hours and at 16 hours.
Both statistical significance and degree of clinical response, were
measured. The strongest clinical effect achieved was with twice-daily
dosing of either concentration. Further, the higher concentration of
Bepreve demonstrated a once-daily clinical effect that was comparable to
the published literature for FDA-approved once-daily ophthalmic solutions
studied in patients with ocular allergies.
The data announced today mirror the results from the 107-patient,
single- center Phase III Bepreve study, announced May 8, 2007, which used
the same study design. ISTA currently is analyzing the results of an ocular
safety study in approximately 850 patients, with preliminary results
anticipated before the end of the second quarter of 2008. Once the Company
completes its analysis of the full dataset, ISTA expects to file a New Drug
Application (NDA) with the FDA during the second half of 2008. ISTA plans
to discuss the study results with the FDA to determine what, if any,
additional information would be required in order to obtain approval for
both a once-daily and twice- daily form of Bepreve.
About Bepreve(TM) (bepotastine ophthalmic solution)
Bepreve has three primary mechanisms of action: it is a non-sedating,
highly selective antagonist of the histamine 1 (H1) receptor, it has a
stabilizing effect on mast cells, and it suppresses the migration of
eosinophils into inflamed tissues. The compound’s primary mechanisms of
action are believed to make it an effective treatment against the signs and
symptoms of allergic conjunctivitis.
Bepotastine was approved in Japan for use as a systemic drug in the
treatment of allergic rhinitis and urticaria/pruritus in July 2000 and
January 2002, respectively, and is marketed by Mitsubishi Tanabe Pharma
Corporation (formerly Tanabe Seiyaku Co., Ltd.) under the brand name
TALION(R). TALION was co-developed by Tanabe Seiyaku and Ube Industries,
Ltd., who discovered bepotastine. In 2001, Tanabe Seiyaku granted Senju
Pharmaceutical Co., Ltd., exclusive worldwide rights, with the exception of
certain Asian countries, to develop, manufacture, and market bepotastine
for ophthalmic use. In 2006, ISTA licensed from Senju the exclusive North
American rights to an eye drop formulation of bepotastine for the treatment
of allergic conjunctivitis.
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. 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.
Any statements contained in this press release that refer 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 bringing a new product to market every 12
to 18 months, completing the preliminary analysis of the data from the
Bepreve ocular safety study in the second quarter of 2008, filing the
Bepreve NDA with the FDA in the second half of 2008, and 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: timely
and successful implementation of ISTA’s strategic initiatives; delays and
uncertainties related to ISTA’s research and development programs
(including the difficulty of predicting the timing or outcome of product
development efforts and the FDA or other regulatory agency approval or
actions); uncertainties and risks regarding market acceptance of and demand
for ISTA’s approved products and the impact of competitive products and
pricing; uncertainties and risks related to ISTA’s ability to properly
manage its growth; uncertainties and risks regarding the continued timely
performance by ISTA’s strategic partners of their respective obligations
under existing collaborations and licensing arrangements; 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, 2007.
ISTA Pharmaceuticals, Inc.
istavision
View drug information on Bepreve.