ISTA Pharmaceuticals, Inc. (NASDAQ: ISTA) announced today positive
results from its Phase 2 randomized, placebo-controlled,
parallel-group environmental clinical study of BEPOSONE™
(bepotastine besilate/steroid) nasal spray for the treatment of
symptoms associated with seasonal allergic rhinitis, the
inflammation of the nasal passages caused by allergies. According
to the trial findings, BEPOSONE nasal spray showed highly
statistically significant improvements compared to placebo in
patients' nasal symptoms following exposure to one of the most
potent seasonal allergy triggers, Mountain Cedar pollen. These
improvements were seen as early as Day 1 of therapy and were
sustained through the two-week treatment period. Statistically
significant improvement was also seen for BEPOSONE within 15
minutes after dosing in a small subgroup of subjects who frequently
evaluated their nasal symptoms for 4 hours after their first nasal
spray dose. Further, safety data demonstrated BEPOSONE was
well-tolerated as a nasal spray, with an adverse event profile
similar to placebo and generally consistent with those observed
with bepotastine besilate dosed as a nasal spray in prior clinical
trials and with other antihistamine nasal sprays.
"We are very encouraged by the results of the BEPOSONE Phase 2
pilot study, which shows promise for the use of a combination
bepotastine besilate/steroid nasal spray for treatment of allergic
rhinitis. Since antihistamines and steroids are often prescribed at
the same time to patients for the treatment of seasonal allergic
rhinitis, we believe there is a need for a combination product that
brings together these two effective treatments in one convenient
nasal spray formulation," commented Timothy R. McNamara, Pharm.D.,
Vice President of Clinical Research and Medical Affairs of ISTA
Pharmaceuticals.
Dr. McNamara continued, "We designed our Phase 2 study to be
similar to what we would expect to be required of a Phase 3 spring
or fall natural allergen exposure environmental study. The study
was intended to provide key information for making strategic
decisions on appropriate Phase 3 study designs with our bepotastine
besilate nasal spray franchise. Based on these results and the
positive Phase 2 results from our single-agent antihistamine nasal
spray of bepotastine besilate, BEPOMAX™, which were reported last
year, we expect to complete some additional Phase 2 studies ahead
of our Phase 3 pivotal program covering both products, slated to
begin in 2013. BEPOSONE and BEPOMAX represent exciting potential
expansions of our prescription allergy product line, currently
focused on BEPREVE® (bepotastine besilate ophthalmic solution) 1.5%
for the treatment of ocular itching associated with allergic
conjunctivitis."
ABOUT THE PHASE 2 BEPOSONE NASAL SPRAY CLINICAL
TRIAL AND TRIAL RESULTS The Phase 2 trial was a randomized,
multi-center, double-masked, placebo-controlled, parallel-group
environmental trial to evaluate the safety and efficacy of
BEPOSONE, dosed twice daily, in patients presenting with allergic
rhinitis caused by Mountain Cedar pollen.
Following initial screening for evidence of Mountain Cedar
pollen allergy, approximately 600 patients in Texas, aged 12 years
and older, were treated twice per day for two weeks with one of
four formulations: bepotastine besilate/steroid combination nasal
spray (BEPOSONE), a nasal spray containing one or the other of the
two active agents, or placebo nasal spray. Patients graded both
individual nasal and ocular symptoms on a twice-daily basis during
the treatment period. The mean grades for responses to questions in
the validated Rhinoconjunctivitis Quality of Life Questionnaire
(RQLQ) were completed at the beginning and end of the trial as a
surrogate measure of clinical benefit.
Safety was evaluated based on several variables, including
recording of adverse events, physical and nasal examinations, ECG
measurements and determination of pharmacokinetic parameters in a
prospectively identified subpopulation, and monitoring of vital
signs.
The clinical study showed BEPOSONE nasal spray provided highly
statistically significant improvement compared to placebo in
reducing total nasal symptoms. Each of the active agents alone, the
steroid and the antihistamine, also provided improvement in nasal
symptoms that was greater than placebo nasal spray and was
approximately additive to the level of improvement over placebo
seen with the combination in BEPOSONE nasal spray. Nasal symptom
improvement superior to placebo was seen as early as Day 1 of
treatment with BEPOSONE and bepotastine nasal sprays, and with
steroid nasal spray beginning on Day 3. Changes in mean RQLQ grades
for BEPOSONE and single agent nasal sprays over the 2-week
treatment period were also significantly better for overall quality
of life (QOL) improvements and for improvements in most or all
individual QOL domain grades than for changes seen with placebo
nasal spray.
In regard to safety, the total number of adverse events was
slightly greater in treatment groups administering
bepotastine-containing nasal sprays, with the most common adverse
events reported being taste, nasal discomfort, headache, and
nosebleed. These adverse events were generally mild. Additionally,
no serious adverse events were observed during the Phase 2
study.
ISTA expects to report comprehensive data from the BEPOSONE
Phase 2 Mountain Cedar pollen trial at an appropriate,
peer-reviewed forum in the future.
ABOUT THE ALLERGIC RHINITIS MARKET
According to the American Academy of Allergy Asthma &
Immunology (AAAAI), approximately 60 million Americans are affected
by allergic rhinitis, an inflammation of the nasal passages caused
by exposure to certain allergens, such as pollen from trees, grass
and plants, animal dander, feathers, dust mites and molds. Allergic
rhinitis is characterized by a number of symptoms, including
sneezing, nasal congestion, nasal itching and runny nose. The eyes,
ears, sinuses and throat also can be affected. Current treatments
for allergic rhinitis include antihistamines, mast cell
stabilizers, anti-inflammatory medications, and steroids. Based on
data from IMS Health in the U.S., approximately 46.8 million
prescriptions were filled for nasal allergy treatments in 2011,
resulting in sales of approximately $2.5 billion.
ABOUT BEPOTASTINE BESILATE Bepotastine
besilate is a non-sedating, highly selective antagonist of the
histamine 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 suggest that
it is a potentially effective treatment for nasal symptoms
associated with seasonal allergic rhinitis.
Bepotastine besilate has been approved in Japan for systemic use
in the treatment of allergic rhinitis since 2000 and for
urticaria/dermal prurituses since 2002. It is marketed as an oral
tablet in Japan by Mitsubishi Tanabe Pharma Corporation (formerly
Tanabe Seiyaku Co., Ltd.) under the brand name TALION®. TALION was
co-developed by Tanabe Seiyaku and Ube Industries, Ltd., who
discovered bepotastine besilate. 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 besilate for ophthalmic use. In 2006, ISTA
licensed the exclusive North American ophthalmic rights to
bepotastine besilate from Senju. In 2007, ISTA licensed exclusive
North American rights to nasal dosage forms of bepotastine besilate
from Tanabe Seiyaku and obtained a future right to negotiate for a
North American license to oral dosage forms of bepotastine besilate
for allergy treatment.
ISTA's eye drop formulation of bepotastine besilate, BEPREVE®
(bepotastine besilate ophthalmic solution) 1.5%, was approved by
the U.S. Food and Drug Administration (FDA) in September 2009 for
the treatment of ocular itching associated with allergic
conjunctivitis. BEPOSONE™ and BEPOMAX™ nasal spray formulations for
seasonal allergic rhinitis are currently investigational drugs in
clinical studies and are not yet available for commercial use.
ABOUT ISTA PHARMACEUTICALS ISTA
Pharmaceuticals, Inc. is a fast growing and the third largest
branded prescription eye care business in the United States with an
expanding focus on allergy therapeutics. ISTA currently markets
four products, including treatments for ocular inflammation and
pain post-cataract surgery, glaucoma and ocular itching associated
with allergic conjunctivitis. ISTA's development pipeline contains
additional candidates in various stages of development to treat dry
eye, ocular inflammation and pain, and nasal allergies.
Headquartered in Irvine, California, ISTA generated revenues of
$160 million in 2011. For additional information about ISTA, please
visit the corporate website at www.istavision.com.
BEPREVE®, BEPOSONE™ and BEPOMAX™ are trademarks owned by ISTA
Pharmaceuticals, Inc. TALION® is a trademark of Mitsubishi Tanabe
Pharma Corporation.
FORWARD-LOOKING STATEMENTS Any statements
contained in this press release that refer to future events or
other non-historical matters are forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended. These forward-looking statements are intended to qualify
for the safe harbor from liability established by the Private
Securities Reform Act of 1995. Without limiting the foregoing, but
by way of example, statements contained in this press release
related to the initiation of further studies and Phase 3 trials for
BEPOSONE and/or BEPOMAX, and presentation and potential
implications of Phase 2 clinical trial results 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 are 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, 2011.
For Investor Relations: Lauren Silvernail 949-788-5302
lsilvernail@istavision.com Jeanie Herbert 949-789-3159
jherbert@istavision.com Kathy Galante Burns McClellan 212-213-0006
kgalante@burnsmc.com For General Media: Justin Jackson Burns
McClellan 212-213-0006 jjackson@burnsmc.com For Trade Media: Tad
Heitmann BioComm Network 714-273-2937 theitmann@BioCommNetwork.com
Web Site: http://www.istavision.com
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