Navigation Links
ISTA Pharmaceuticals Announces FDA Advisory Committee to Review Bepreve(TM) for the Treatment of Ocular Itching Associated with Allergic Conjunctivitis
Date:6/1/2009

IRVINE, Calif., June 1 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA), 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.


'/>"/>
SOURCE ISTA Pharmaceuticals, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Arena Pharmaceuticals to Present at the NewsMakers in the Biotech Industry Conference
2. Schering-Plough/Merck Pharmaceuticals Announce FDA Filing Acceptance of New Drug Application for Loratadine/Montelukast Tablet
3. Provectus Pharmaceuticals, Inc. Begins Phase 2 Clinical Trial for Metastatic Melanoma
4. Idenix Pharmaceuticals to Present at Two Upcoming Investor Conferences
5. Vista Partners Updates Coverage on Tapestry Pharmaceuticals
6. Transcept Pharmaceuticals, Inc. to Present at UBS 2007 Global Life Sciences Conference
7. Crystal Research Associates, LLC Issues Executive Informational Overview(R) (EIO(R)) on Tapestry Pharmaceuticals, Inc.
8. Amylin Pharmaceuticals to Webcast Corporate Overview During 43rd Annual Meeting of the European Association for the Study of Diabetes
9. Major Pharma Clinical Case Studies From Amgen, AstraZeneca, GSK, Intermune, Cephalon Inc, Sunesis Pharmaceuticals and Dartmouth Medical School During Fall Clinical Focused Programs
10. Provectus Pharmaceuticals, Inc. releases summary results of phase 1 metastatic melanoma study
11. Class Settlement Could Result in Considerable Savings for Certain Consumers of Prescription Pharmaceuticals
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/27/2016)... ... June 27, 2016 , ... "FCPX editors can now reveal their ... Cut Pro X," said Christina Austin - CEO of Pixel Film Studios. , ... Pro X users can now reveal the media of their split screens with ...
(Date:6/27/2016)... Overland Park, KS (PRWEB) , ... June 27, 2016 , ... ... leader in retailers of Eyeglasses . , Millions of individuals in the United ... life, eyeglasses have become a way to both correct vision and make a fashion ...
(Date:6/26/2016)... North Carolina (PRWEB) , ... June 26, 2016 , ... ... release of a new product that was developed to enhance the health of felines. ... for centuries. , The two main herbs in the PawPaws Cat Kidney Support ...
(Date:6/25/2016)... Austin, TX (PRWEB) , ... June 25, 2016 , ... ... Fellow of the American College of Mohs Surgery and to Dr. Russell Peckham for ... popular and highly effective treatment for skin cancer. The selective fellowship in Mohs Micrographic ...
(Date:6/25/2016)... Long Beach, CA (PRWEB) , ... June 25, 2016 , ... ... from UCLA with Magna Cum Laude and his M.D from the David Geffen School ... San Diego and returned to Los Angeles to complete his fellowship in hematology/oncology at ...
Breaking Medicine News(10 mins):
(Date:6/26/2016)... Story Highlights: ... the health care industry is causing providers to review ... Deloitte offers a suite of solutions for health care ... cost optimization: labor resource analysis, revenue cycle optimization and ... outcomes and better economics ...
(Date:6/24/2016)... June 24, 2016 ... announced the addition of the " Global Markets ... This report focuses ... an updated review, including its applications in various applications. ... market, which includes three main industries: pharmaceutical and biotechnology, ...
(Date:6/24/2016)... -- Research and Markets has announced the addition ... report to their offering. ... The World Market for Companion Diagnostics covers the world ... in the report includes the following: , ... by Region (N. America, EU, ROW), 2015-2020 , World ...
Breaking Medicine Technology: