Navigation Links
ISTA Pharmaceuticals' New Drug Application for Bepreve(TM) Accepted for Review by U.S. Food and Drug Administration
Date:1/15/2009

IRVINE, Calif., Jan. 15 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA), today announced that ISTA's New Drug Application (NDA) for Bepreve(TM) (bepotastine ophthalmic solution) has been accepted for review by the U.S. Food and Drug Administration (FDA). The Company is seeking approval for Bepreve as an eye drop treatment for ocular itching associated with allergic conjunctivitis. The Company expects a standard review of ten months and has been given a user fee action date of September 12, 2009.

ISTA's Phase III clinical studies with Bepreve demonstrated highly statistically significant reductions in the primary endpoints of ocular itching. In addition, the results showed Bepreve had a statistically significant effect on the rapidity of response and on additional signs or symptoms of ocular allergy, including improvement in nasal symptoms. There were no serious ocular adverse events reported in patients dosed with Bepreve.

About Bepreve(TM) (bepotastine ophthalmic solution)

Assuming approval from the FDA, Bepreve would participate in ISTA's largest market to date. IMS Health estimates the U.S. ocular allergy market generated approximately $560 million in sales in 2007. 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 the signs and symptoms of 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 $4.7 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, 2007, and its most recent Quarterly Report on Form 10-Q for the quarter ended September 30, 2008.


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

Related medicine technology :

1. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
2. Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML
3. Solvay Pharmaceuticals, Inc. and Wyeth Pharmaceuticals Announce Receipt of an FDA Action Letter for Bifeprunox, an Investigational Treatment for Schizophrenia
4. Callisto Pharmaceuticals Opens Additional Sites for Phase II Clinical Trial of Atiprimod in Advanced Carcinoid Cancer Patients
5. WallSt.net (www.wallst.net) Updates the Investment Community Through an All-New Interview With RegeneRx Biopharmaceuticals CEO
6. Quark Pharmaceuticals, Inc. Presented Positive Preclinical Results of Systemic RNAi Compound for Acute Renal Failure (ARF)
7. Peregrine Pharmaceuticals Doses First Patient in Cotara(R) Phase II Brain Cancer Trial In India
8. Nabi Biopharmaceuticals Announces Second Quarter 2007 Financial Results
9. Access Pharmaceuticals Provides Update on Clinical Development Plan of ProLindac
10. Quark Pharmaceuticals Extends Research Agreement with State University of New York for Proprietary siRNA Compounds for Acute Hearing Loss
11. Acura Pharmaceuticals, Inc. Secures Financing to Fund Pivotal Phase III Clinical Trial for Lead Aversion(R) Technology Product Candidate
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/2/2017)... Mass. , June 2, 2017  NxStage Medical, ... renal care, today announced new findings demonstrating positive biochemical ... ® System One™. The data will be presented ... in Madrid, Spain . ... to Improve Home Dialysis Network in Europe ...
(Date:5/30/2017)... , May 30, 2017 DarioHealth Corp. (NASDAQ: DRIO), ... data solutions, today announced that it will be presenting at the ... 8:00 AM PT. Erez Raphael , CEO, of DarioHealth will ... conference will be held on June 6th & 7th, 2017 at ... in the small / micro-cap space. ...
(Date:5/30/2017)... Israel , May 30, 2017 Therapix ... pharmaceutical Company specializing in the development of cannabinoid-based ... present a company overview at three upcoming scientific ... 7th Annual LD Micro Invitational: ... Date:                     ...
Breaking Medicine Technology:
(Date:6/28/2017)... ... June 28, 2017 , ... ... governance program for mid-market executives as a kick-off to the fifth annual CEO ... 24, 2017 on the University of Pennsylvania campus, followed by the two-day convention, ...
(Date:6/28/2017)... ... June 28, 2017 , ... Schneider ... planning assistance to clients in southern Montana, is announcing a focused charity effort ... , The outreach programs offered by Zoo Montana provide students with current knowledge ...
(Date:6/27/2017)... Fla. (PRWEB) , ... June 27, 2017 , ... ... today announced the appointment of Mike Finnegan to the position of Executive Vice ... years of experience in healthcare technology, telehealth and medical device sales leadership. He ...
(Date:6/27/2017)... Orlando, FL (PRWEB) , ... June 27, 2017 ... ... the leading payment solution for many of the health care industry’s hospitals and ... its new patient financing portal for select customers. Parasail Health is a San ...
(Date:6/27/2017)... (PRWEB) , ... June 27, 2017 , ... A January ... been projected to reach a staggering $6.81 billion by the year 2024 according to ... at a faster rate than those made from titanium. Los Angeles area clinic Beverly ...
Breaking Medicine News(10 mins):