ISTA Pharmaceuticals Reports Results From the First of Two Trials in the REMURA(TM) Phase 3 Clinical Program for Dry

IRVINE, CA, Jul 28 (MARKET WIRE) --
ISTA Pharmaceuticals, Inc. (NASDAQ: ISTA), today announced top-line
results from the first of its two Phase 3 studies to evaluate the
short-term safety and efficacy of two concentrations of REMURA(TM)
(bromfenac ophthalmic solution for dry eye) in alleviating the signs and
symptoms of dry eye disease. The company's Phase 3 safety and efficacy
program, which consists of two studies known as EAST and WEST, is being
conducted under a Special Protocol Assessment (SPA) agreed upon with the
U.S. Food and Drug Administration (FDA). Today's top-line results are
from the WEST study; the EAST study is now fully enrolled and the Company
expects to announce top-line results from the EAST study during fourth
quarter of 2011.

According to preliminary analysis of the top-line results from the WEST
study, while REMURA was highly effective in treating a sign and symptom
of dry eye, it was not statistically significantly better than placebo, a
common outcome reported in studies testing other dry eye therapies. From
baseline, both concentrations of REMURA and the placebo showed highly
statistically significant improvement (p < 0.0001) in one sign and one
symptom. The co-primary end-points identified in the SPA require REMURA
to achieve a statistically significant difference from placebo, not
baseline, which was not achieved in the WEST Study.

In analyzing the patient data, the higher concentration of REMURA
achieved statistical significance against placebo in the sign of
conjunctival staining as measured using the Lissamine Green (LG) Staining
test among a sub-population of female patients 51-70 years of age with
moderate dry eye disease. Safety data demonstrated REMURA was
well-tolerated, with an adverse event profile similar to placebo and
consistent with those observed previously with REMURA in a Phase 2 study
and with other prescription dry eye drops. All three formulations were
rated by patients as very comfortable.

"Consistent with our Phase 2 Study data, today's results show REMURA has
a significant impact on the signs and symptoms of dry eye when compared
to baseline. Since REMURA did not meet its co-primary end points in the
WEST study, armed with this data, we expect to amend the statistical plan
to appropriately focus the EAST study," stated Timothy R. McNamara,
Pharm.D., Vice President of Clinical Research and Medical Affairs of ISTA
Pharmaceuticals. "The EAST study is now fully enrolled, but the database
has not been locked. We continue to analyze the WEST data, and once we
see the data from the EAST Study, which we plan to announce in the fourth
quarter, we'll make decisions about future development plans."

About the Phase 3 Study
ISTA is testing two concentrations of REMURA in
two separate studies, known as EAST and WEST, conducted under a common
protocol. Together, the studies are designed to enroll a total of
approximately 1,000 patients with mild or moderate dry eye disease,
randomized on a 1:1:1 basis to receive one of the two bromfenac dose
levels, or placebo, in both eyes, twice daily, for 42 days. A safety
follow-up visit occurred 10 days after dosing ended. To establish
efficacy, this study has a co-primary endpoint requiring statistically
significant differences in favor of REMURA compared to placebo in both
one sign and one symptom of dry eye disease. The sign of conjunctival
staining is being measured using the Lissamine Green (LG) Staining test,
while the subjective symptoms are being measured using the Ocular Surface
Disease Index (OSDI)*, a validated 12-question survey used by patients to
document symptoms. The WEST study enrolled a total of 420 patients, 140
in each of the three arms.

To control for placebo responders in the trial, all patients entered a
14-day washout period prior to dosing, during which they used an
over-the-counter (OTC) artificial tear. At the end of the 14-day washout
period, only patients who had no change in a sign or symptom with the OTC
artificial tear were then randomized into one of three study arms. In
analyzing the data, patients who enrolled with severe dry eye and used
the OTC artificial tears four times daily, showed no change in staining
or symptoms after two weeks of therapy. Of those same severed dry eye
patients that were subsequently treated with placebo twice daily, a
statistically significant reduction in both staining and OSDI score
versus baseline was observed over two weeks of therapy.

Conference Call
ISTA will host a conference call with a simultaneous
webcast today, July 28, 2011, at 4:30 PM Eastern Time, to discuss the
preliminary Phase 3 data for the REMURA dry eye WEST study and its second
quarter 2011 results. To access the live conference call, U.S. and
Canadian participants may dial 866-804-6922; international participants
may dial 857-350-1668. The access code for the live call is 73568588. To
access the 24-hour audio replay, U.S. and Canadian participants may dial
888-286-8010; international participants may dial 617-801-6888. The
access code for the replay is 37743515. This conference call also will be
webcast live and archived on ISTA's website for 30 days at
http://www.istavision.com.

ABOUT DRY EYE DISEASE
Dry eye disease occurs when there is an imbalance
of tears that provide moisture and lubrication to the eye, which can
result in pain, itching, redness, blurry vision, light sensitivity and/or
a gritty sensation or feeling of sand in the eye, all of which are
related to localized inflammation of the ocular surface. Causes of dry
eye include environmental conditions, such as air conditioning, smoke and
dust, aging and menopause, side effects from antihistamines and birth
control pills, Sjoegren's syndrome, rheumatoid arthritis and structural
problems with the eye lid's ability to close. Left untreated, dry eye can
lead to abrasions on the surface of the eye and damage to the cornea,
potentially affecting the ability to see permanently. Current treatments
include artificial tears and ointments, topical steroids, topical
immunomodulators and punctal occlusion (closing or plugging of tear
drains). Dry eye disease is a large and growing market, with 2011
worldwide prescription sales expected to be about $700 million.

ABOUT BROMFENAC OPHTHALMIC SOLUTION
REMURA(TM) (bromfenac ophthalmic
solution for dry eye) is a sterile, topical non-steroidal
anti-inflammatory (NSAID) compound under investigation for use as an
ophthalmic agent to alleviate the signs and symptoms of dry eye disease.
ISTA acquired U.S. ophthalmic rights to bromfenac in May 2002 under a
license from Senju Pharmaceuticals Co. Ltd.

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.

* Ocular Surface Disease Index (OSDI) is a copyright Copyright 1995 of
Allergan, Inc.

REMURA(TM) (bromfenac ophthalmic solution for dry eye) is a trademark of
ISTA Pharmaceuticals, Inc.

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
announcement of additional Phase 3 results from the EAST study and
changes to statistical plan for the EAST study 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,
and Form 10-Q for the first quarter ended March 31, 2011.

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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