IRVINE, Calif., April 13 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals, Inc. announced today that data on two of the Company’s marketed products, Xibrom(TM) and Vitrase(R), will be presented at the 2006 annual meeting of The Association for Research in Vision and Ophthalmology (ARVO) in Fort Lauderdale, FL. Xibrom(TM) (bromfenac ophthalmic solution) 0.09%, the Company’s topical, twice-daily, non-steroidal anti-inflammatory solution (NSAID), is approved by the Food & Drug Administration for the treatment of ocular inflammation and pain following cataract surgery. ISTA’s Vitrase(R) (Ovine Hyaluronidase) is FDA-approved for use as a spreading agent, for hypodermoclysis, and as an adjunct in subcutaneous urography. In addition, Vitrase(R) has been studied for the treatment of vitreous hemorrhage.
“We are pleased to announce the upcoming schedule of presentations relating to Xibrom(TM) and Vitrase(R) at the ARVO conference, a prestigious scientific forum for ophthalmology,” stated Vicente Anido, Jr., Ph.D., President and Chief Executive Officer of ISTA Pharmaceuticals. “These presentations will provide further support of the potential clinical utility of these products and highlight our commitment to innovation in ophthalmic therapeutics.”
ARVO poster presentations featuring Xibrom(TM): Sunday, April 30, 2006, 2:30 PM - 4:15 PM, Location: Hall B/C Topical Xibrom(TM) 0.09%, Significantly Reduced Ocular Pain Following Cataract Surgery Sunday, April 30, 2006, 2:30 PM - 4:15 PM, Location: Hall B/C Pharmacokinetic Profile of Topically Applied Bromfenac Sodium Ophthalmic Solution 0.1% in Subjects Undergoing Cataract Surgery Thursday, May 04, 2006, 8:30 AM - 10:15 AM, Location: Hall B/C Concentrations of Radioactivity in Ocular Tissues Following a Single Topical Ocular Dose of 14C-Bromfenac Ophthalmic Solution (Xibrom(TM)) Thursday, May 04, 2006, 8:30 AM - 10:15 AM, Location: Hall B/C Bromfenac 0.09% versus Diclofenac Sodium 0.1% versus Ketorolac Tromethamine 0.5% in the Treatment of Acute Pseudophakic Cystoid Macular Edema ARVO poster presentations featuring Vitrase(R): Sunday, April 30, 2006, 2:30 PM - 4:15 PM, Location: Hall B/C The Compatibility of Vitrase(R) Combined with Kenalog(R) Thursday, May 04, 2006, 8:30 AM - 10:15 AM, Location: Hall B/C The Compatibility of Vitrase(R) Combined With Avastin(R) Sunday, April 30, 2006, 2:30 PM - 4:15 PM, Location: Hall B/C A Simple Predictor of Vitrase(R) Efficacy for BCVA Improvement in Diabetic Patients With Severe Vitreous Hemorrhage Sunday, April 30, 2006, 2:30 PM - 4:15 PM, Location: Hall B/C A Simple Predictor of Vitrase(R) Efficacy for Successful Laser Treatment in Diabetic Patients With Severe Vitreous Hemorrhage Monday, May 01, 2006, 8:30 AM - 10:15 AM, Location: Hall B/C Use of Vitrase(R) for Vitreous Hemorrhage in Non-Surgical Candidates Thursday, May 04, 2006, 8:30 AM - 10:15 AM, Location: Hall B/C Comparison of the Purity of Various Bovine and Ovine Testicular Hyaluronidase Preparations to a Preparation of Purified Ovine Testicular Hyaluronidase (Vitrase(R)) ABOUT XIBROM(TM) AND THE U.S. OPHTHALMIC ANTI-INFLAMMATORY MARKET
Xibrom(TM) (bromfenac ophthalmic solution) 0.09% is a sterile, topical, non-steroidal anti-inflammatory solution for the treatment of ocular inflammation and pain following cataract surgery. Senju Pharmaceuticals Co. Ltd. has marketed this product in Japan since 2000 with over 7.9 million uses since that time. ISTA acquired U.S. marketing rights for Xibrom(TM) in May 2002 under a license from Senju.
ISTA completed two pivotal Phase III clinical studies of Xibrom(TM) in the United States. In these studies involving 527 patients, a statistically significant proportion of patients treated with Xibrom(TM) achieved treatment success, defined as the complete absence of ocular inflammation compared to those patients who received placebo. This effect was evident in the Xibrom(TM) group as early as day 3 following initiation of treatment. Furthermore, 75% of patients who experienced pain after cataract surgery were pain-free within two days of being treated with Xibrom(TM) twice daily. In addition, 98% of patients experiencing pain after cataract surgery and receiving Xibrom(TM) twice daily were pain-free within six days of treatment.
The topical ophthalmic anti-inflammatory market consists of steroids, NSAIDS and combination products. Based upon management estimates of sales and 2004 prescription data from IMS, U.S. sales in 2004 in this market were approximately $400 million, with total prescriptions of 8.6 million.
For additional information on Xibrom(TM), including full prescribing information, please visit http://www.istavision.com/products/products_xibrom.asp.
ABOUT VITRASE(R)
ISTA’s Vitrase(R) is a proprietary formulation of highly purified ovine hyaluronidase. In May 2004, the FDA approved Vitrase(R) in a lyophilized 6200 USP Units multi-purpose vial for use as a spreading agent, for hypodermoclysis and as an adjunct in subcutaneous urography; a 200 USP Units/mL vial in sterile solution for such indications was approved by the FDA in December 2004. FDA’s approval of Vitrase(R) for use as a spreading agent in May 2004 removed hyaluronidase from the FDA’s drug shortage list where it had been listed since 2001.
In addition to its approval by FDA for use as a spreading agent, for hypodermoclysis and as an adjunct in subcutaneous urography, Vitrase(R) has been studied for the treatment of vitreous hemorrhage. A New Drug Application (NDA) was filed with the FDA for the treatment of vitreous hemorrhage in 2002 and an approvable letter for that NDA was received in 2003. In the letter, the FDA cited issues primarily related to the sufficiency of the efficacy data submitted with the NDA. The FDA requested additional analysis of the existing data and an additional confirmatory clinical study based upon that analysis. We are continuing to discuss with the FDA the clinical issues raised in the approvable letter and will determine the next appropriate steps based on these discussions. Vitrase(R) has also been studied for the treatment of diabetic retinopathy.
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, ocular 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.
Any statements contained in this press release that refer to future events or other non-historical matters are 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, 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, 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, Inc.; or Media - Justin Jackson, jjackson@burnsmc.com, orInvestors - Lisa Burns or Laura Siino, +1-212-213-0006, lsiino@burnsmc.com,all of Burns McClellan, for ISTA Pharmaceuticals, Inc.
Web site: http://www.istavision.com/
