ISTA Pharmaceuticals Reports Positive, Topline Results From Its Phase 2 Clinical Trial of Bepotastine Besilate Nasal

IRVINE, CA, Apr 28 (MARKET WIRE) --
ISTA Pharmaceuticals, Inc. (NASDAQ: ISTA) today announced positive,
topline results from its Phase 2 dose-ranging, environmental clinical
trial of bepotastine besilate 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, each of
three concentrations of bepotastine besilate nasal spray showed
statistically significant improvements compared to placebo in patients'
nasal symptoms following exposure to Mountain Cedar pollen during the
peak season for this allergen. These improvements were seen on day one of
therapy and were sustained through the two-week treatment period.
Further, safety data demonstrated bepotastine besilate was well-tolerated
as a nasal spray, with an adverse event profile similar to placebo and
consistent with those observed with bepotastine besilate dosed as a nasal
spray in prior clinical trials and with other antihistamine nasal sprays.

"One of the most potent seasonal allergy triggers in the United States,
Mountain Cedar pollen produces a very strong allergic reaction in
sensitive patients and is an excellent allergen to assess the activity of
bepotastine besilate as a nasal spray," commented Timothy R. McNamara,
Pharm.D., Vice President of Clinical Research and Medical Affairs of ISTA
Pharmaceuticals. "We are very pleased that the first U.S. environmental
clinical trial conducted by ISTA showed great promise for the use of
bepotastine besilate for allergic rhinitis. Importantly, the Phase 2
protocol for this study is substantially similar to those we would
anticipate for the design of a pivotal program."

Dr. McNamara continued, "A next step in the development plan for this
drug candidate is to explore clinical study designs for a bepotastine
besilate/steroid combination nasal spray and, after completing
discussions with the FDA, we plan to initiate a Phase 2 study in Mountain
Cedar pollen with our bepotastine besilate/steroid combination nasal
spray before the end of 2011. This program represents an exciting
potential expansion of our prescription allergy product line, currently
focused on BEPREVE(R) (bepotastine besilate ophthalmic solution) 1.5% for
the treatment of ocular itching associated with allergic conjunctivitis."

ABOUT THE PHASE 2 BEPOTASTINE BESILATE NASAL SPRAY CLINICAL TRIAL AND
TRIAL RESULTS

The Phase 2 trial was a randomized, multi-center, double-masked,
placebo-controlled, dose-ranging, parallel-group environmental trial to
evaluate the safety and efficacy of bepotastine besilate, 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 with one of three concentrations of
bepotastine besilate nasal spray or placebo for two weeks. Patients
graded both individual nasal and ocular symptoms on a daily basis.

Safety was evaluated based on several variables, including adverse
events, physical and nasal examinations, vital signs and the mean grades
for responses to questions in the validated Rhinoconjunctivitis Quality
of Life Questionnaire (RQLQ) completed at the beginning and end of the
trial. Pharmacokinetic (PK) data on the three concentrations of
bepotastine besilate nasal spray were assessed based on blood draws, and
electrocardiograms were additionally collected at pre-dose and post-dose
from a subset of patients.

The clinical trial showed all three concentrations of bepotastine
besilate nasal spray provided statistically significant improvement
compared to placebo in reducing total nasal symptoms. Statistically
significant improvements also were seen for all three concentrations
compared to placebo in terms of total ocular symptoms. All domains in the
RQLQ also showed a statistically significant improvement in quality of
life with two of the three bepotastine besilate nasal spray
concentrations.

The PK information collected in the Mountain Cedar trial supported the
principle that the systemic bioavailability of bepotastine from nasal
sprays approximated dose proportionality. In regard to safety, the total
number of adverse events was similar in all treatment groups, with the
most common adverse events reported being taste, headache, nasal pain and
discomfort, and nosebleed. These adverse events were generally mild.
Additionally, no serious drug-related adverse events were observed during
the Phase 2 trial.

ISTA expects to report comprehensive data from the Phase 2 trial at an
appropriate, peer-reviewed forum in the near 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, grasses 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-inflammatories, and steroids. Based on data from
IMS Health in the U.S., approximately 46.3 million prescriptions were
filled for nasal allergy treatments in 2010, 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/pruritus
since 2002. It is marketed in Japan 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 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(R)
(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. ISTA's nasal
spray formulations for treatment of nasal symptoms of seasonal allergic
rhinitis currently are investigational drugs in clinical studies and have
not yet been approved by the FDA.

ABOUT ISTA PHARMACEUTICALS

ISTA Pharmaceuticals, Inc. is a fast growing and the fourth 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. The company'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 $156.5 million in 2010.
For additional information about ISTA, please visit the corporate website
at www.istavision.com.

BEPREVE(R) is a trademark of ISTA Pharmaceuticals, Inc.

TALION(R) 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.
Without limiting the foregoing, but by way of example, statements
contained in this press release related to the potential implications of
Phase 2 clinical trial results, exploration of clinical study designs for
a bepotastine besilate/steroid combination nasal spray, initiating a
Phase 2 study with bepotastine besilate/steroid combination nasal spray
before the end of 2011 and potential expansion of ISTA's prescription
allergy product line 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 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, 2010.

CONTACTS

For Investor Relations:
Lauren Silvernail
949-788-5302
lsilvernail@istavision.com

Jeanie Herbert
949-789-3159
jherbert@istavision.com

Juliane Snowden
Burns McClellan
212-213-0006
jsnowden@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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