PRNewswire
IRVINE, Calif., June 26 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals,
Inc. (Nasdaq: ISTA) today announced the Dermatologic and Ophthalmic Drugs
Advisory Committee appointed by the U.S. Food and Drug Administration (FDA)
recommended the approval of Bepreve(TM) (bepotastine besilate ophthalmic
solution) 1.5% as an eye drop treatment for ocular itching associated with
allergic conjunctivitis. The Committee voted unanimously 7 to 0 in favor of
approving Bepreve after reviewing comprehensive safety and efficacy data from
ISTA's clinical program.
"The Committee's vote supports our belief that Bepreve provides a safe and
effective treatment for ocular itching associated with allergic
conjunctivitis. We will continue to work closely with the FDA as we approach
the September 12th action date," stated Vicente Anido Jr., Ph.D., President
and Chief Executive Officer of ISTA Pharmaceuticals.
Although the FDA is not required to follow the Committee's guidance, the
Agency usually considers the Committee's recommendation when evaluating
pending applications. The FDA has assigned a Prescription Drug User Fee
Action Date of September 12, 2009.
About Bepreve (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.
Bepotastine was approved in Japan for use as a systemic drug in the
treatment of allergic rhinitis and urticaria/pruritus in July 2000 and January
2002, respectively, and is marketed 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.
About ISTA Pharmaceuticals
ISTA Pharmaceuticals is an ophthalmic pharmaceutical company. ISTA's
products and product candidates addressing the $5.1 billion U.S. prescription
ophthalmic industry include therapies for inflammation, ocular pain, glaucoma,
allergy, and dry eye. The Company currently markets three products and 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.
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 ISTA's expectation of becoming the leading niche
ophthalmic pharmaceutical company 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; uncertainties and risks
regarding market acceptance of and demand for ISTA's approved products; 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, 2008, and its most recent Quarterly Report on Form 10-Q for the quarter
ended March 31, 2009.
SOURCE ISTA Pharmaceuticals, Inc.
-0- 06/26/2009
/CONTACT: Vince Anido, Ph.D., +1-949-788-5311, [email protected]; or
Lauren Silvernail, +1-949-788-5302, [email protected], both of ISTA
Pharmaceuticals; or Investors: Juliane Snowden, +1-917-657-3972,
[email protected], or Media: Justin Jackson, [email protected], both of
Burns McClellan, +1-212-213-0006, for ISTA Pharmaceuticals/
/Web Site: http://www.istavision.com /
(ISTA)
CO: ISTA Pharmaceuticals, Inc.; Dermatologic and Ophthalmic Drugs Advisory
Committee; Food and Drug Administration
ST: California
IN: MTC PHA HEA
SU:
PR
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8695 06/26/2009 10:28 EDT http://www.prnewswire.com