Navigation Links
ISTA Pharmaceuticals Announces Positive Results for Phase IIb Study of Ecabet Sodium
Date:1/22/2009

IRVINE, Calif., Jan. 22 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA), today announced positive results from the Company's Phase IIb clinical study of ecabet sodium, which is being developed as a treatment for dry eye disease. Patients treated with ecabet sodium achieved a strong positive trend in the objective sign of Tear Film Break-Up Time (TFBUT) and a positive trend in the objective sign of quantity of tears produced (Schirmer Test). In contrast, there were no trends seen in the placebo group for either objective sign. In addition, there were no trends seen in either group in subjective symptoms as measured by the Ocular Surface Disease Index (OSDI) or patient's worst reported symptom. In Phase II tests where observations are not powered to show statistical significance, strong and positive trends are used as indicators of potential efficacy in subsequent Phase III studies.

"The Phase IIb results from this environmental study add further support to our belief that ecabet sodium has the ability to treat signs and symptoms of dry eye syndrome. Ecabet sodium may provide advantages over other products used to treat dry eye and those that are in development, as we believe ecabet sodium not only improves the quality of tears but also increases the quantity of tears," stated Vicente Anido Jr., Ph.D., President and Chief Executive Officer of ISTA Pharmaceuticals. "After reviewing the guidance from and our discussions with the FDA, we believe that by conducting two successful Phase III environmental clinical trials for improvement in signs and two successful Phase III controlled chamber clinical trials for the improvement of symptoms, we should receive marketing approval. In addition, we are expecting results from a Phase II clinical trial studying the potential of a lower strength of Xibrom to treat the signs and symptoms of dry eye disease in the first half of 2009. Once this lower strength Xibrom trial is completed, we will make a decision on which product or products in our dry eye franchise to move into Phase III trials, which could start as early as 2010."

ISTA's previous two Phase II trials of ecabet, which were conducted in a controlled environment chamber, demonstrated positive trends in patient's symptoms (OSDI and patient's worst symptom, both trials) and in the signs of corneal staining (one trial) and blink rate (both trials). The Company believes the lack of response to ecabet in symptoms in the most recent trial is not of concern, in part because the OSDI responses to ecabet sodium were strong and predictable in the previous Phase II trials. ISTA believes that given the ability to demonstrate a positive effect on signs in the environment and on symptoms in the controlled environment chamber, there is now a clear path forward to Phase III studies and New Drug Application filing for this product.

Background on ISTA's Recent Phase IIb Study Results

ISTA's Phase IIb trial randomized 144 patients to receive either ecabet sodium or placebo four times per day for 43 days. The object of the study was to investigate ecabet sodium's effects on the objective signs of tear production (Anesthetized and Unanesthetized Schirmer Tests) and tear film quality (TFBUT) and subjective symptoms (OSDI, patient's worst symptom) in patients with dry eye disease when administered under normal environmental conditions.

In the analysis of responders to both ecabet sodium and placebo, results of the Anesthetized Schirmer Test in the Phase IIb study revealed a strong trend for ecabet sodium, which approached statistical significance versus placebo. This result is important because it indicates an effect on basal tear secretion, which is one of the main factors in the etiology of dry eye disease. In addition, the percentage of patients who responded to ecabet sodium was greater than that seen in the trials that led to the approval of the only currently approved product on the market for dry eye disease. Further, this trend in increased Schirmer Test score was seen as early as day 22 of treatment and continued to trend upwards through day 43. Adverse events were uncommon and similar between the treatment and placebo groups, and there were no serious ocular or systemic adverse events.

Another important finding in this trial was that patients with more severe disease as measured by the Anesthetized Schirmer Test, TFBUT and specific staining attributes were more likely to respond to ecabet sodium than placebo. Thus, in future Phase III trials, these specific attributes can be used for screening of patients who would be most likely to benefit from treatment with ecabet sodium.

About Ecabet Sodium

ISTA acquired U.S. rights to ecabet sodium for the treatment of dry eye syndrome from Senju Pharmaceuticals Co., Ltd., in November of 2004. Ecabet sodium is already marketed in Japan as an oral agent for gastric ulcers and gastritis by Mitsubishi Tanabe Pharma Corporation (formerly Tanabe Seiyaku Co., Ltd.) as an originator of ecabet sodium.

Ecabet sodium represents a new class of molecules that increase the quantity of mucin produced by conjunctival goblet cells and corneal epithelia. Mucin is a glycoprotein component of tear film that lubricates while retarding moisture loss from tear evaporation.

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 referring 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 anticipated design of future ecabet sodium studies, the results of future or ongoing studies with lower strength Xibrom, ISTA's intention to select one or more products to advance to Phase III in 2010, ISTA's belief that ecabet sodium not only improves the quality of tears but also increases the quantity of tears, ISTA's belief that conducting two successful Phase III environmental clinical trials for improvement in signs and two successful Phase III controlled chamber clinical trials for the improvement of symptoms should lead to marketing approval of ecabet sodium 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; the uncertain nature of clinical research and 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. ISTA Pharmaceuticals New Drug Application for Bepreve(TM) Accepted for Review by U.S. Food and Drug Administration
2. Jazz Pharmaceuticals, Inc. Completes Enrollment in Second of Two Phase III Clinical Trials of Sodium Oxybate to Treat Fibromyalgia
3. AcelRx Pharmaceuticals Reports Positive Results from a Clinical Trial of Sublingual Sufentanil/Triazolam NanoTab(TM) Combination (ARX-03) in Treating Procedural Pain and Anxiety
4. Idenix Pharmaceuticals Initiates Proof-of-Concept Study of IDX184 for the Treatment of Hepatitis C Virus (HCV)
5. Solace Pharmaceuticals Initiates Phase IIa Trial of Glial Cell Modulator SLC022 in Post-Herpetic Neuralgia
6. Quark Pharmaceuticals Announces Dosing of the First Patient in Phase I/II Clinical Trial for Systemically Delivered siRNA Drug Candidate for Delayed Graft Function
7. Cylene Pharmaceuticals Initiates Phase I Trial With CX-4945 -Breakthrough First-in Class Inhibitor of CK2
8. Arena Pharmaceuticals Announces Initiation of Phase 1 Clinical Trial of Type 2 Diabetes Drug Candidate in Partnership with Ortho-McNeil-Janssen Pharmaceuticals
9. Arena Pharmaceuticals Announces Preliminary Results of Phase 2b Clinical Trial of APD125 for the Treatment of Insomnia
10. Keryx Biopharmaceuticals, Inc. Reports Phase 1/2 Data on KRX-0401 (Perifosine) at 50th Annual Meeting of American Society of Hematology
11. Portola Pharmaceuticals Initiates Phase II Trial of Novel IV and Oral Anti-Platelet Drug in Non-Urgent Percutaneous Coronary Intervention
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/3/2016)... , May 3, 2016   Diplomat Pharmacy, Inc. (NYSE: DPLO) announced today that it is ... a video of two patients who tell their personal story and encourage those at risk ... Meet Jacque: Hepatitis C ... ... Diplomat Specialty Pharmacy (PRNewsFoto/Diplomat Pharmacy, Inc.) ...
(Date:5/3/2016)... May 3, 2016  Forté Elements, LLC (Forté) is excited to announce the launch ... address the nutritional needs of recovery for a variety of clinical conditions. Founded in ... Photo - http://photos.prnewswire.com/prnh/20160502/362548 Logo -  http://photos.prnewswire.com/prnh/20160502/362547LOGO ... ... ...
(Date:5/2/2016)... 2016  Deerfield announced today it led the ... Inc. Graybug Vision is an early stage pharmaceutical ... care for ocular diseases including wet age-related macular ... first developed at Johns Hopkins University and has ... Graybug Vision is developing ophthalmology products ...
Breaking Medicine Technology:
(Date:5/4/2016)... (PRWEB) , ... May 04, 2016 , ... ... has received a new patent for its innovative Secure Messaging platform, which includes ... control. The new patent extends Cirius’s portfolio of patents around innovative features ...
(Date:5/4/2016)... Charlotte, NC (PRWEB) , ... May 04, 2016 ... ... platform for sleep wellness and sleep disorder management, today announced it has secured ... World Innovation Lab (WiL) and existing investors. The investment will be used by ...
(Date:5/4/2016)... ... May 04, 2016 , ... IsoComforter, Inc., ... introduction of the innovative newly improved Iso-Hip Wrap. The newly designed hip ... design enhances comfort and enables the patient to enjoy the benefits of cold ...
(Date:5/4/2016)... ... May 04, 2016 , ... a2z, Inc. is pleased ... Canadian Association for Enterostomal Therapy (CAET) will be utilizing powerful and innovative technology ... attendees and exhibitors for the 2016 WOCN Society & CAET Joint Conference—which is ...
(Date:5/4/2016)... ... , ... Washington Wellness Center today announced its tenth anniversary of providing a ... out as an idea to provide a holistic approach to wellness has now become ... Dr. David Swanekamp, Chiropractic Physician , the wellness center offers a complete range ...
Breaking Medicine News(10 mins):