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

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

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:
(Date:10/13/2015)... , ... October 13, 2015 , ... ... companies in the United States, today announced the release of its limited edition ... new Cranberry Cocktail Agua Fresca. All feature the unique flavor combinations and delicious ...
(Date:10/13/2015)... ... October 13, 2015 , ... ... announced today their sponsorship of the Microsoft Dynamics AXUG, GPUG and NAVUG Summits ... GPUG Summit and NAVUG Summit are independent user conferences designed and led by ...
(Date:10/13/2015)... ... October 13, 2015 , ... Dr. Poneh Ghasri, dentist ... on September 18, 2015. The research, which was conducted at the Dental Institute at ... colleagues, show connections between stress during pregnancy and future dental health in the child. ...
(Date:10/13/2015)... ... ... Protein is essential to good health. You need it to make the bricks ... does the average man need in order to stay healthy? , The answer ... Harvard Men's Health Watch . Most Americans get about 15% of their calories ...
(Date:10/13/2015)... ... October 13, 2015 , ... Georgia Partnership ... in communities throughout Georgia, along with affiliate organizations, Alabama Partnership for Telehalth (ATP) ... telehealth summits for Fall 2015. , Each of the three conferences share ...
Breaking Medicine News(10 mins):
(Date:10/13/2015)... DIEGO , October 13, 2015 ... today announced the appointment of Harry Lander , PhD ... the Company,s Chairman & CEO David Koos as ... small molecule and immuno-oncological therapeutics. --> Regen ... the appointment of Harry Lander , PhD as its ...
(Date:10/13/2015)...  Yesterday Congresswoman Renee Ellmers (R-NC-02) visited ... located in Holly Springs, NC . ... ® (Influenza Vaccine) using cell-culture technology, a state-of-the-art production ... is not reliant on chicken eggs. 1,2 On ... business of Novartis AG in the US, which for ...
(Date:10/12/2015)... 12, 2015 Given the intricacy of ... challenging to deliver an ophthalmic drug effectively to a specific ... successful ocular drug delivery. These include dilution of a drug ... of conjunctiva and drug permeation issues with respect to the ... topical eye drops, is lost due to the aforementioned barriers. ...
Breaking Medicine Technology: