IRVINE, Calif., Aug. 25 ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA), today announced positive preliminary Phase 3 results from the Company's Xibrom((TM)) (bromfenac ophthalmic solution) 0.09% QD (once-daily) confirmatory clinical study. Xibrom 0.09% QD achieved statistical significance in the study's primary endpoint, the absence of ocular inflammation 15 days following cataract surgery, and the secondary efficacy endpoint, the elimination of ocular pain one day post surgery. During the study, no serious ocular or systemic adverse events occurred, and the safety profile is consistent with ISTA's currently marketed Xibrom twice-daily formulation.
The confirmatory Phase 3 study was a multi-center, randomized, double-masked, parallel-group study in 299 patients who underwent cataract surgery in one eye. Patients were assigned randomly (1:1) to receive either Xibrom once daily or placebo. Dosing began one day before cataract surgery and continued for 14 days following surgery. The proportion of patients experiencing no pain was assessed at Day 1 post surgery, and the proportion of patients with complete absence of ocular inflammation was assessed at Day 15 post surgery. Ocular inflammation was evaluated using a summed ocular inflammation score (SOIS) and was measured by an assessment of immune cells in the anterior chamber of the eye ("cells") and cellular debris ("flare"). The secondary efficacy endpoint was evaluated via a pain score from the Ocular Comfort Grading Assessment recorded in a diary. Patients also graded their symptoms at each office visit, which included photophobia, the chief symptomatic complaint following cataract surgery.
In December 2008, ISTA announced integrated results from two Phase 3 studies with Xibrom 0.09% QD. Based on the results of the studies, the U.S. Food and Drug Administration (FDA) required ISTA to conduct an additional confirmatory study with Xibrom 0.09% QD. The current study confirms the efficacy and safety of Xibrom 0.09% QD which was previously demonstrated in an identical Phase 3 clinical trial in 2008. Once the Company completes its analysis of the full dataset, ISTA expects to file a supplemental New Drug Application (sNDA) with the FDA prior to the end of 2009, seeking approval of the Xibrom 0.09% formulation for once-daily treatment for the inflammation and pain following cataract surgery.
Xibrom((TM)) (bromfenac ophthalmic solution)
Xibrom is a topical non-steroidal anti-inflammatory compound for the treatment of ocular inflammation and pain following cataract surgery. Xibrom, under a different trade name but identical formulation, was launched in Japan in 2000 by Senju Pharmaceuticals Co. Ltd. ISTA acquired U.S. marketing rights for Xibrom in 2002 and launched the product in the U.S. in 2005. According to IMS data, Xibrom is the 2009 dollar market share leader in the U.S. ophthalmic nonsteroidal anti-inflammatory market, with net sales of $33.8 million for the six-month period ended June 30, 2009.
Xibrom currently is labeled as an eye drop used twice-daily beginning 24 hours after cataract surgery. Xibrom has not been approved by the FDA as a once-daily treatment. ISTA's sNDA filing will request the Agency to approve a change to the drug's label to reflect Xibrom's efficacy as a once-daily treatment in this patient population.
About ISTA Pharmaceuticals
ISTA Pharmaceuticals is an ophthalmic pharmaceutical company. ISTA's products and product candidates addressing the $5.1 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 that refer 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 ISTA's filing of a supplemental New Drug Application (sNDA) with the FDA for Xibrom QD prior to the end of 2009 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; 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, 2008, and its most recent Quarterly Report on Form 10-Q for the quarter ended June 30, 2009.
SOURCE ISTA Pharmaceuticals, Inc.