ISTA Pharmaceuticals Announces Positive Results for Phase IIb Study of Ecabet Sodium
IRVINE, Calif., January 22, 2009 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals, Inc., 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.
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.
Posted: January 2009