ISTA Pharmaceuticals, Inc.
IRVINE, CA, May 10, 2012 (MARKETWIRE via COMTEX) --ISTA Pharmaceuticals, Inc. (NASDAQ: ISTA), today presented results
from the second of two Phase 3 studies of PROLENSA(TM) (bromfenac
ophthalmic solution), the Company's once-daily topical nonsteroidal
anti-inflammatory product candidate for the treatment of ocular
inflammation and pain following cataract surgery. The findings showed
PROLENSA met both the study's primary and secondary efficacy
endpoints, producing statistically greater clearing of subjects'
ocular inflammation by Day 15 and a greater proportion of subjects
that were pain free at one day post-cataract surgery than placebo.
These data were presented in a poster session at the 2012 Association
for Research in Vision and Ophthalmology (ARVO) Annual Meeting being
held from May 6-10, 2012, in Fort Lauderdale, FL. Last month, ISTA
presented similar results from the Company's first Phase 3 study in a
poster session at the 2012 American Society of Cataract and
Refractive Surgery (ASCRS) Symposium and Congress in Chicago, IL.
Data from both studies were collected under a common protocol and
conducted and analyzed as two independent studies in the U.S. Based
on the results of the two Phase 3 studies, ISTA intends to file a New
Drug Application (NDA) with the U.S. Food and Drug Administration
(FDA) for PROLENSA in the first half of 2012.
Additional data from the poster presentation, titled "Efficacy of
Low-Concentration, Modified Bromfenac Ophthalmic Solution
Administered Once Daily for Ocular Inflammation and Pain Associated
with Cataract Surgery", demonstrated that there were no serious
drug-related ocular or systemic adverse events, and that PROLENSA's
safety profile was consistent with ISTA's currently marketed
once-daily topical nonsteroidal anti-inflammatory (NSAID) compound,
BROMDAY(TM) (bromfenac ophthalmic solution) 0.09%.
Authors of the poster were Sharon K. Klier, MD, MPH, James H. Peace,
MD, Damien F. Goldberg, MD, James A. Gow, MD, Timothy R. McNamara,
PharmD for the Low Concentration Bromfenac Ophthalmic Solution Once
Daily Study Group.
ABOUT THE PHASE 3 PROGRAM
ISTA conducted two Phase 3 multi-center,
randomized, double-masked, parallel-group controlled studies. Each
study enrolled two hundred and twenty (220) subjects who underwent
cataract surgery in one eye (unilateral). Subjects were assigned
randomly (1:1) to receive either PROLENSA once daily or placebo
(vehicle) once daily. Dosing of PROLENSA began one day before
cataract surgery and continued on the day of surgery and for 14 days
following cataract surgery. The proportion of subjects experiencing
no ocular pain was assessed at Day 1 post surgery and throughout the
study, and the proportion of subjects with complete absence of ocular
inflammation was assessed as early as Day 1 post surgery through Day
22 post surgery. Ocular inflammation was evaluated using a summed
ocular inflammation score (SOIS) and was measured by an assessment of
cells in the anterior chamber of the eye ("cells") and cellular
protein ("flare"). The secondary efficacy endpoint was evaluated via
a pain score from the Ocular Comfort Grading Assessment (OCGA)
recorded in a patient's diary. Safety was assessed based on several
variables, including adverse events, ophthalmic evaluations, and
OCGA.
ABOUT PROLENSA(TM)
PROLENSA(TM) (bromfenac ophthalmic solution) is
being developed as a once-daily topical nonsteroidal
anti-inflammatory compound for the treatment of ocular inflammation
and pain following cataract surgery. PROLENSA incorporates a lower
concentration of bromfenac than the company's current once-daily
NSAID, BROMDAY (bromfenac ophthalmic solution) 0.09% in a new,
modified ophthalmic formulation. From 2005 until 2011, ISTA marketed
XIBROM (bromfenac ophthalmic solution)(R) 0.09% in the U.S. for
twice-daily use for the treatment of postoperative inflammation and
the reduction of ocular pain in patients who have undergone cataract
surgery. In October of 2010, ISTA received FDA approval for
once-daily BROMDAY and discontinued shipments of XIBROM in February
2011. BROMDAY is currently the only once-daily treatment option in
the $370 million U.S. ophthalmic nonsteroidal anti-inflammatory
market. ISTA acquired the U.S. ophthalmic rights to bromfenac in May
2002 under a license from Senju Pharmaceuticals Co. Ltd. A U.S.
patent was issued to ISTA's licensor, Senju, for PROLENSA, which
expires in September 2025. PROLENSA is an investigational drug and
not yet available for commercial use.
ABOUT ISTA PHARMACEUTICALS
ISTA Pharmaceuticals, Inc. is 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. 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 $160 million in 2011. For additional information about
ISTA, please visit the corporate website at www.istavision.com.
BROMDAY(TM) (bromfenac ophthalmic solution) 0.09%, XIBROM (bromfenac
ophthalmic solution)(R) 0.09% and PROLENSA(TM) (bromfenac ophthalmic
solution) are trademarks 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 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 filing of a new drug application
with the FDA 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 FDA 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, 2011 and ISTA's Quarterly Report on Form
10-Q for the quarter ended March 31, 2012.
For General Media:
Justin Jackson
Burns McClellan
212-213-0006
[email protected]
For Trade Media:
Tad Heitmann
BioComm Network
714-273-2937
[email protected]
Web Site: http://www.istavision.com