ISTA Pharmaceuticals Highlights Bepreve Clinical Data at the 2009 Annual Meeting of the American College of Allergy, Asthma & Immunology (ACAAI)
MIAMI, Nov. 9 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals,
Inc. (NASDAQ:ISTA) , today announced additional
results from the Company's Bepreve(TM) (bepotastine besilate
ophthalmic solution) 1.5% Phase 3 clinical studies. These results
were presented in poster sessions at the 2009 Annual Meeting of the
American College of Allergy, Asthma & Immunology (ACAAI) in
Miami Beach, FL.
In a poster presentation titled, "Treatment of Ocular Itching
with Bepotastine Besilate Ophthalmic Solution 1.5% for Subjects
with More Severe Itching Response in a Conjunctival Allergen
Challenge (CAC) Clinical Model of Allergic Conjunctivitis,"
integrated results from two Phase 3 studies demonstrated Bepreve
1.5% was as effective in suppressing ocular itching in patients
with more severe itching as in patients with all grades of ocular
itching. A total of 157 patients were enrolled in two 7-week,
masked, randomized, placebo-controlled CAC clinical studies (1
single site, 1 multi-site). 113 patients exhibited bilateral ocular
itching grades greater than or equal to 3 at screening during study
visit 2. Individuals were assessed at 15 minutes, 8 hours, or 16
hours following instillation at study visits spaced 2 weeks apart
during the enrollment period. The difference in mean itching grades
(placebo-active) for the more severely affected subjects was within
plus or minus 0.1 unit of the differences for the entire
intent-to-treat (ITT) population. Authors of the poster were J. I.
Williams, J. A. Gow, P. J. Gomes, M. B. Abelson, and T. R.
McNamara.
ISTA presented more results from CAC clinical trials with
Bepreve 1.0% and 1.5% in the following poster presentations at the
same meeting:
Bepotastine Besilate Ophthalmic Solution 1.5% Reduces Nasal
Congestion with Rapid Onset in a Clinical Model of Allergic
Conjunctivitis
Authors: G. L. Torkildsen, J. I. Williams, J. A. Gow, P. J.
Gomes, T. R. McNamara
The Conjunctival Allergen Challenge (CAC) Model of Allergic
Conjunctivitis - Does Assumption of a Normal Data Distribution
Influence the Means for Evaluating Clinical and Statistical
Significance?
Authors: K. S. Kennedy, J. I. Williams, J. A. Gow, M. B.
Abelson, T. R. McNamara
Abstracts are published in the November issue of Annals of
Allergy, Asthma & Immunology and are available online at
www.annallergy.org.
About Bepreve(TM) (bepotastine besilate ophthalmic solution)
1.5%
Bepreve 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 are believed
to make it an effective treatment against ocular itching associated
with allergic conjunctivitis.
Bepreve was approved by the U.S. Food and Drug Administration in
September 2009 for the treatment of ocular itching associated with
allergic conjunctivitis. Bepotastine has been approved in Japan for
systemic use in the treatment of allergic rhinitis since 2000 and
urticaria/pruritus since 2002. It is marketed 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. 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 the
exclusive North American rights from Senju to an eye drop
formulation of bepotastine for the treatment of allergic
conjunctivitis. In 2007, ISTA licensed exclusive North American
rights to nasal dosage forms of bepotastine from Tanabe Seiyaku and
obtained a future right to negotiate for a North American license
to oral dosage forms of bepotastine for allergy treatment.
Full prescribing information for Bepreve(TM) is available on
ISTA Pharmaceuticals' website at http://www.istavision.com/pdf/Bepreve_insert.pdf.
About ISTA Pharmaceuticals
ISTA Pharmaceuticals is the fourth largest branded ophthalmic
pharmaceutical business in the U.S. ISTA's four marketed products
plus its product candidates include therapies for inflammation,
ocular pain, glaucoma, allergy, and dry eye. The Company is
developing a strong product pipeline to fuel future growth and
market share, 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 http://www.istavision.com/.
Bepreve(TM) (bepotastine besilate ophthalmic solution) 1.5%,
Xibrom(TM) (bromfenac ophthalmic solution) 0.09%, and Istalol®
(timolol maleate ophthalmic solution) 0.5% are trademarks of ISTA
Pharmaceuticals.
Source: ISTA Pharmaceuticals, Inc.
CONTACT: Vince Anido, Ph.D., +1-949-788-5311, vanido@istavision.com, or
Lauren Silvernail, +1-949-788-5302, lsilvernail@istavision.com,
both of ISTA
Pharmaceuticals; or Investors: Juliane Snowden, jsnowden@burnsmc.com, or
Media: Justin Jackson, jjackson@burnsmc.com, both
of Burns McClellan,
+1-212-213-0006, for ISTA Pharmaceuticals
Web Site: http://www.istavision.com/
