ISTA Pharmaceuticals Announces Positive Results for Phase 2 Study of Low-Dose Bromfenac in Dry Eye Disease
IRVINE, Calif., June 8 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals, Inc. (NASDAQ: ISTA) , today announced positive results from a proof-of-concept Phase 2 clinical study in subjects with dry eye disease (keratoconjuctivitis sicca) using a new, proprietary, low-dose formulation of bromfenac, the active ingredient in Xibrom(R) (bromfenac ophthalmic solution) 0.09%. The study achieved statistical significance in the primary endpoint of the objective sign of conjunctival staining (Lissamine Green test) as compared to baseline. The study also achieved statistical significance on the objective sign of corneal staining (Fluorescein test) as compared to baseline. Patients also achieved statistically significant improvements in subjective symptoms measured by the Ocular Surface Disease Index (OSDI) and improvement in patients' most bothersome ocular symptoms.
"The strong clinical results from this proof-of-concept study further support our belief that a modified, low-dose formulation of bromfenac has the potential ability to effectively and conveniently treat signs and symptoms of dry eye disease and provide fast and sustainable relief for patients. Bromfenac's strong safety profile should support long-term treatment, which would be necessitated due to the chronic inflammatory nature of dry eye disease," stated Vicente Anido, Jr., Ph.D., President and Chief Executive Officer of ISTA Pharmaceuticals.
"ISTA is strongly committed to focusing on dry eye disease. The results of this study may help identify patients that would be most suitable for a larger, placebo-controlled study. These data come on the heels of our recently announced positive ecabet sodium Phase 2b study results in ISTA's dry eye franchise. We will analyze the data from both programs to determine which product candidate or candidates to move into further advanced studies, which could begin as early as 2010."
ISTA's proof-of-concept, Phase 2 bromfenac study enrolled 38 patients who exhibited signs and symptoms consistent with moderate dry eye disease. All patients received low-dose bromfenac bilaterally twice a day for 42 days. Patient baseline scores were recorded prior to the first treatment with low-dose bromfenac and were compared to baseline at Day 14, Day 42 and Day 52. The study was designed to investigate the effects of low-dose bromfenac compared to baseline on the objective signs of conjunctival staining (Lissamine Green test) and corneal staining (Fluorescein test), as well as subjective symptoms (OSDI and patient's most bothersome ocular symptoms), when administered under normal environmental conditions.
Results of the Lissamine Green test in the Phase 2 study revealed statistical significance for low-dose bromfenac versus the patients' baseline scores starting as early as Day 14 and sustained through Day 52, ten days post treatment. Lissamine Green, a validated staining technique that stains the entire ocular surface, allows analysis of dry eye damage on the conjunctiva to determine the severity of dry eye disease. Adverse events were uncommon, and there were no serious ocular or systemic adverse events.
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 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 ISTA's low-dose formulation of bromfenac, ISTA's intention to select one or more products to advance to Phase 3 in 2010, ISTA's belief that low-dose bromfenac has an effect on the conjunctiva and cornea's dry eye damage 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, 2008 and its most recent Quarterly Report on Form 10-Q for the quarter ended March 31, 2009.
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