Marketwire
IRVINE, CA, Mar 22, 2011 (MARKETWIRE via COMTEX) --
ISTA Pharmaceuticals, Inc. (NASDAQ: ISTA), today announced
additional results from the Company's BEPREVE(R) (bepotastine
besilate ophthalmic solution) 1.5% Phase 3 clinical studies in
allergic conjunctivitis. These results were presented in poster
sessions at the 2011 American Academy of Allergy, Asthma and
Immunology (AAAAI) Annual Meeting in San Francisco, CA.
In a poster presentation titled "Bepotastine Besilate Ophthalmic
Solution 1.5% Reduces Nonocular Composite Symptom (NOCS) Scores 16
Hours Following Dosing in the Conjunctival Allergen Challenge (CAC)
Model of Allergic Conjunctivitis," the Phase 3 studies demonstrated
BEPREVE was statistically superior to placebo in reducing summed NOCS
scores up to 16 hours after ophthalmic dosing. The data shows support
for the clinical effectiveness of BEPREVE in reducing nonocular
symptoms associated with allergic conjunctivitis. Authors of the
poster were J. I. Williams, T. T. Macejko, M.T. Bergmann, E. J.
Meier, M. B. Abelson, J. A. Gow, and T. R. McNamara.
ISTA presented additional effectiveness results from the BEPREVE CAC
clinical studies in the following poster presentations at the same
meeting:
Bepotastine Besilate Ophthalmic Solution 1.5% Produces Strong
Clinical Benefit for Ocular Itching Immediately Following Dosing in
the Conjunctival Allergen Challenge (CAC) Model of Allergic
Conjunctivitis
Authors: J. C. Clark, J. I. Williams, P. J. Gomes, M.
B. Abelson, J. A. Gow, and T. R. McNamara
Bepotastine Besilate Ophthalmic Solution 1.5% Reduces Tearing 16
Hours Following Dosing in the Conjunctival Allergen Challenge (CAC)
Model of Allergic Conjunctivitis
Authors: J. A. Gow, E. B. McLaurin,
F. K. Kurata, M. B. Abelson, J. I. Williams, and T. R. McNamara
ABOUT BEPREVE(R) (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(R). 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 the 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 is available on ISTA's
website at http://www.istavision.com/pdf/Bepreve_insert.pdf.
ABOUT ISTA PHARMACEUTICALS
ISTA Pharmaceuticals, Inc., is the fourth
largest and fastest growing 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.