IRVINE, Calif., Feb. 21 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals, Inc. today announced positive preliminary results from the Company’s randomized, three-arm (placebo/3.0%/3.9%) Phase IIb clinical study of ecabet sodium, a prescription eye drop being evaluated for the treatment of dry eye syndrome (keratoconjunctivitis sicca or KCS).
The preliminary results of the study demonstrated a strong trend in efficacy for the lower (3%) dose with respect to ecabet sodium’s ability to address two objective signs of dry eye syndrome, corneal staining and blink rate. In addition, patients treated with the lower dose of ecabet sodium reported positive trends for reductions in symptomatology as measured by ocular surface disease index and most bothersome symptom. In the preliminary results, no efficacy trends versus placebo were observed with respect to the higher (3.9%) dose. Further analyses of the Phase IIb results are ongoing.
ISTA’s Phase IIb study was designed to identify the appropriate sign and symptom and time course for future studies. Generally, improvement in one sign and one symptom in Phase III studies is considered acceptable by the FDA for approval of a prescription dry eye product. Therefore, a total of 162 patients were enrolled in the Company’s U.S., randomized, three-arm Phase IIb trial and were randomly assigned to receive placebo, 3.0% or 3.9% ecabet sodium in the study eye four times a day for 90 days. Patients were evaluated for signs and symptoms four times during the trial both prior to and following exposure to a controlled adverse environment (“dry eye chamber”). The trial evaluated ocular signs, including corneal and conjunctival staining, tear film breakup time and blink rate, and ocular symptoms, including burning or stinging, itchiness or scratchiness, grittiness or sandiness, foreign body sensation, haziness and blurriness. In addition, the preliminary findings suggest a favorable safety profile.
Based on data compiled from various publicly available sources, ISTA estimates that sales in the U.S. prescription dry eye market were approximately $200 million in 2005 and are anticipated to grow to approximately $350 to $700 million in annual sales within three to five years.
Vicente Anido, Jr., Ph.D., President and Chief Executive Officer of ISTA stated, “We are very encouraged by the preliminary findings, which show that ecabet sodium may be effective in addressing signs and symptoms of dry eye syndrome, a painful and debilitating eye disorder. The positive trends in symptomatology that were observed in our Phase IIb trial appear better than the results we have seen in other drugs studied for this syndrome.” Dr. Anido added, “Our plan is to complete our analyses of these results to confirm our preliminary findings and, in parallel, move quickly into a smaller, short-term confirmatory study designed to further define the subpopulation of patients to enroll and other elements of our Phase III studies. Assuming timely and successful completion of this confirmatory study, our plan is to initiate a Phase III study during 2007.”
ISTA will host a conference call with a simultaneous webcast today, February 21, 2006 at 10:30 AM Eastern Time to address the Company’s Phase IIb preliminary findings of ecabet sodium. To access the live conference call, U.S. and Canadian participants may dial 800-573-4752; international participants may dial 617-224-4324. The access code for the live call is 61988838. To access the 24-hour audio replay, U.S. and Canadian participants may dial 888-286-8010; international participants may dial 617-801-6888. The access code for the replay is 72342095. This conference call will also be webcast live and archived on ISTA’s website for 30 days at http://www.istavision.com.
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. Senju’s ecabet sodium eye drop product is currently in Phase II testing in Japan for the treatment of dry eye syndrome and is already marketed in Japan as an oral agent for gastric ulcers and gastritis by Tanabe Seiyaku Co., Ltd as an originator of ecabet sodium.
Ecabet sodium represents a new class of molecules that increase the quantity and quality 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
ISTA is a specialty pharmaceutical company focused on the development and commercialization of unique and uniquely improved ophthalmic products. ISTA’s products and product candidates seek to address serious diseases and conditions of the eye such as dry eye, vitreous hemorrhage, diabetic retinopathy, hyphema, glaucoma, pain and inflammation. Building on this pipeline, ISTA’s goal is to continue its growth as a specialty pharmaceutical company by acquiring complementary products, either already marketed or in late-stage development. For additional information regarding ISTA, please visit ISTA Pharmaceuticals’ Website at http://www.istavision.com/ .
Statements contained in this press release that refer to future events or other non-historical matters are forward-looking statements. For example, and without limiting the foregoing, the statements that the company will complete its analysis and confirm its preliminary Phase IIb findings, successfully complete, in parallel, a confirmatory study, and initiate a Phase III study with respect to ecabet sodium during 2007 are forward-looking statements. Except as required by law, ISTA disclaims any intent or obligation to update any forward-looking statements. Such 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: the risk that full analysis of the Phase IIb data or further testing, will not reflect the preliminary Phase IIb results, or support any or all of the conclusions provided in this press release; delays and uncertainties related to ISTA’s ecabet sodium development program (including the difficulty of predicting the timing or outcome of ISTA’s product development efforts and the FDA or other governmental agency approval or actions); and such 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, 2004 and ISTA’s Quarterly Reports on Form 10-Q for the quarters ended March 31, 2005, June 30, 2005 and September 30, 2005.
ISTA Pharmaceuticals, Inc.
CONTACT: Vince Anido, +1-949-788-5311, vanido@istavision.com, or LaurenSilvernail, +1-949-788-5302, lsilvernail@istavision.com, both of ISTAPharmaceuticals; or Justin Jackson, Media, jjackson@burnsmc.com, or LisaBurns, Investors, or Laura Siino, lsiino@burnsmc.com, all of BurnsMcClellan, +1-212-213-0006, for ISTA Pharmaceuticals
Web site: http://www.istavision.com/
