Navigation Links
ISTA Pharmaceuticals Announces New Phase III Clinical Findings to Support Bepreve NDA Filing
Date:4/30/2008

her, the higher concentration of Bepreve demonstrated a once-daily clinical effect that was comparable to the published literature for FDA-approved once-daily ophthalmic solutions studied in patients with ocular allergies.

The data announced today mirror the results from the 107-patient, single- center Phase III Bepreve study, announced May 8, 2007, which used the same study design. ISTA currently is analyzing the results of an ocular safety study in approximately 850 patients, with preliminary results anticipated before the end of the second quarter of 2008. Once the Company completes its analysis of the full dataset, ISTA expects to file a New Drug Application (NDA) with the FDA during the second half of 2008. ISTA plans to discuss the study results with the FDA to determine what, if any, additional information would be required in order to obtain approval for both a once-daily and twice- daily form of Bepreve.

About Bepreve(TM) (bepotastine ophthalmic solution)

Bepreve has three primary mechanisms of action: it is a non-sedating, highly selective antagonist of the histamine 1 (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 2
'/>"/>

SOURCE ISTA Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2 3 4

Related medicine technology :

1. Cequent Pharmaceuticals Johannes Fruehauf, MD, Ph.D., to be Featured Speaker at RNAi World Congress in Boston - May 2, 2008
2. Idenix Pharmaceuticals Reports First Quarter 2008 Financial Results
3. Peregrine Pharmaceuticals Completes Patient Enrollment in First Stage of Bavituximab Phase II Breast Cancer Trial
4. Poniard Pharmaceuticals Announces Final Picoplatin Data from Phase 2 Small Cell Lung Cancer Trial Demonstrating Survival Benefit
5. Idenix Pharmaceuticals Presents Positive Preclinical Data on HCV Programs at The Annual Meeting of The European Association for the Study of the Liver (EASL)
6. Strativa Pharmaceuticals Announces Phase III Results for Loramyc(R) to Treat Oropharyngeal Candidiasis
7. Raptor Pharmaceuticals Corp. Initiates Phase IIa Clinical Study for Convivia(TM)
8. Shareholder Class Action Filed Against Vertex Pharmaceuticals Incorporated by the Law Firm of Schiffrin Barroway Topaz & Kessler, LLP
9. Anadys Pharmaceuticals Presents Data on ANA598, a Non-Nucleoside Inhibitor of the HCV Polymerase, at the 21st International Conference on Antiviral Research
10. Alseres Pharmaceuticals Expands Sites for the First Stage of the ALTROPANE(R) Phase III Clinical Trial Program
11. Celator(R) Pharmaceuticals Successfully Uses Nanoparticles to Administer Hydrophobic Drug Combinations
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/21/2013)... , May 21, 2013  Cephasonics, ... platform, today announced the introduction of the ... complete network-based communications with all cQuest Ultrasound™ ... embedded-ultrasound technology, including this new capability, at ... Paulo, Brazil from May 21-24.  ...
(Date:5/21/2013)... 2013 iHealth Lab Inc., a pioneer ... healthcare products and a powerful integrated mobile app ... of two new fitness products to its existing ... the Wireless Pulse Oximeter and Wireless Activity and ... iHealth Lab is also excited ...
(Date:5/21/2013)... Hurel Corporation ("Hurel"), a world-leading provider of ... today announced the appointment of James S. ... of Directors. Dr. MacDonald is the former Executive Vice ... ("SPRI"), which was the pharmaceutical development arm of Schering ... in 2009. Over a career that has ...
Breaking Medicine Technology:Cephasonics Unveils Next-Generation Wireless-Imaging Technology for cQuest Ultrasound Hardware Platforms 2iHealth Lab adds new products and partners to mobile personal healthcare offering 2iHealth Lab adds new products and partners to mobile personal healthcare offering 3Hurel Corporation Appoints Leading Pharmaceutical Executive and Toxicologist Dr. James S. MacDonald to Board of Directors 2
... Cardica, Inc. (Nasdaq: CRDC ) ... General Surgery at the Red Cross Hospital Clementinenhaus, ... laparoscopic procedures using Cardica,s, proprietary Microcutter XPRESS™ 30 ... several sigmoidectomies, an appendectomy and a small intestinal ...
... , For the fourth year, the Fondation,Médéric ... for evidence-based psychosocial,interventions for people with dementia and their ... care and share best,practices. Applications can be submitted from ... http://www.alz.co.uk/award . Psychosocial research involves or ...
Cached Medicine Technology:Dr. Andreas Kuthe Performs First Laparoscopic Procedures Using Cardica's Microcutter XPRESS™ 30 Surgical Cutting and Stapling Device 2Dr. Andreas Kuthe Performs First Laparoscopic Procedures Using Cardica's Microcutter XPRESS™ 30 Surgical Cutting and Stapling Device 34th Alzheimer's Awards Announced in Search of Global Solutions for Better Dementia Care 2
(Date:5/21/2013)... (PRWEB) May 21, 2013 Everspark Interactive, ... firms, has been growing rapidly over the past year ... was hired to spearhead interactive marketing efforts for Kids ... , Everspark started as a local effort, specializing ... guiding search traffic to a company's website. The company ...
(Date:5/21/2013)... May 21, 2013 Romio , ... with trusted services & businesses, announced today that it ... Medical Care. , Emergency Medical Care is located in ... 24 hours a day. The guarantee of seeing ... a promising resource for the neighborhood and a great ...
(Date:5/21/2013)... Alan Mozes HealthDay Reporter , , MONDAY, ... used by millions of people with chronic obstructive ... cardiovascular complications among older patients, a new large ... patients over age 65 who are prescribed long-acting ... beta-agonists (such as Serevent). Both medications are commonly ...
(Date:5/21/2013)... effects of poorly controlled asthma symptoms on sleep ... been confirmed in a new study. , ... and school absences are important indicators of asthma ... to explore the associations between asthma, sleep quality, ... using both objective and subjective measures," said principal ...
(Date:5/21/2013)... After the success of its inaugural 1,000 lb. Meltdown ... Boot Camp Goderich will be hosting its 2nd Annual 1,000 ... fitness center located at 199 Anglesea Street Goderich, Ontario. ... is to inspire and motivate local community residents to lose ... fee to participate is discounted to $40 for the 28-day ...
Breaking Medicine News(10 mins):Health News:Everspark Named Interactive Marketing Company for Kids II 2Health News:Romio Announces Mini Video Series Featuring Local Business Emergency Medical Care 2Health News:Certain COPD Meds Might Raise Heart Risks, Study Says 2Health News:Certain COPD Meds Might Raise Heart Risks, Study Says 3Health News:Asthma symptoms impair sleep quality and school performance in children 2Health News:Goderich Fitness Center Promotes 2nd Annual 1,000 lb. Meltdown Challenge to Fight Obesity With All Proceeds Raised Going to Local Charity 2Health News:Goderich Fitness Center Promotes 2nd Annual 1,000 lb. Meltdown Challenge to Fight Obesity With All Proceeds Raised Going to Local Charity 3
... (BRONX, NY) Researchers at the Albert Einstein College ... first time that cancers can be successfully treated by ... published in the October 31 issue of PloS One, ... virus-infected cells before they turn cancerous. , The Einstein ...
... BioMed Realty Trust, Inc.,(NYSE: BMR ) today announced ... 30, 2007 after the market closes on Wednesday, November ... Officer, and Kent Griffin,Chief Financial Officer, will host an ... November 8, 2007 to discuss the company,s,financial results and ...
... SGX Pharmaceuticals, Inc.,(Nasdaq: SGXP ) announced today ... conferences during which Mike Grey, president & chief,executive officer ... Company,s oncology pipeline. The conference information is as,follows: ... at 9:00 AM Pacific Daylight ...
... 30 PharmAthene, Inc., a leading,biodefense company specializing ... chemical and biological terrorism,announced today that it is ... /,Acumen BioFin 9th Annual Healthcare Conference on Tuesday, ... for the Company will be David P.,Wright, President ...
... LOS ANGELES Healthcare providers have observed it for years ... life while battling their cancer live longer. Now, a ... with locally advanced non-small cell lung backs that observation. ... other classic predictors of survival. , In the past, weve ...
... Virus Shows Promise as Metastatic Cancer Treatment , ... and can differentiate between normal and cancerous cells. The ... cancers, such as small-cell lung cancer. , Cancer-killing viruses ... therapies for localized cancer. But so far their success ...
Cached Medicine News:Health News:Einstein scientists treat cancer as an infectious disease -- with promising results 2Health News:Einstein scientists treat cancer as an infectious disease -- with promising results 3Health News:BioMed Realty Trust to Report 2007 Third Quarter Results 2Health News:SGX Pharmaceuticals to Present at Three Upcoming Investor Conferences 2Health News:Quality of life: most important predictor of survival for advanced NSCLC patients 2Health News:Other highlights in the Oct. 30 JNCI 2Health News:Other highlights in the Oct. 30 JNCI 3Health News:Other highlights in the Oct. 30 JNCI 4
Long-Sleeve Bolero for targeted compression in the upper arms, upper back and shoulder areas. Plush-shielded hook and eye front closure for comfort and convenient application....
Velcro® closure, uniform contour compression, available as 9" and 12" bands for abdominal support, 9" can be used as a breast wrap....
Sub Pectoral Breast Augmentation Wrap...
CDIs Ultra-Comfort Bra™ is designed with special single needle stitching that places the cup seams away from critical surgical sites....
Medicine Products: