IRVINE, Calif., June 1 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals, Inc. , today announced it has received notification from the U.S. Food and Drug Administration (FDA) that the Dermatologic and Ophthalmic Drugs Advisory Committee will review ISTA’s New Drug Application (NDA) for Bepreve(TM) (bepotastine ophthalmic solution) on June 26, 2009.
On November 13, 2008, ISTA announced it had filed its NDA with the FDA for Bepreve as an eye drop treatment for ocular itching associated with allergic conjunctivitis. The NDA filing includes data from ISTA’s Phase III clinical studies with Bepreve. The Phase III studies demonstrated highly statistically significant reductions in the primary endpoints of ocular itching. As bepotastine is a new chemical entity in the U.S., ISTA expected an Advisory Committee would be convened for Bepreve. ISTA continues to expect a standard review of ten months and has been given a Prescription Drug User Fee Action (PDUFA) date of September 12, 2009.
About Bepreve(TM) (bepotastine ophthalmic solution)
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 for 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 the FDA’s timely review and approval of Bepreve, ISTA’s belief the FDA will review and take action on Bepreve within ten months of filing and 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.
CONTACT: Vince Anido, +1-949-788-5311, vanido@istavision.com, or Lauren
Silvernail, +1-949-788-5302, lsilvernail@istavision.com, both of ISTA
Pharmaceuticals; or Media, Justin Jackson, jjackson@burnsmc.com, or
Investors, Juliane Snowden, jsnowden@burnsmc.com, both of Burns McClellan,
+1-212-213-0006, for ISTA Pharmaceuticals
Web site: http://www.istavision.com/
