ISTA Pharmaceuticals Reports Results From the Second of Two Studies in the REMURA(TM) Phase 3 Clinical Program for Dry Eye Disea

ISTA Pharmaceuticals Reports Results From the Second of Two Studies in the REMURA(TM) Phase 3 Clinical Program for Dry Eye Disease

IRVINE, CA, Oct 13, 2011 (MARKETWIRE via COMTEX) -- ISTA Pharmaceuticals, Inc. ISTA -4.22% today announced top-line results from the second of its two Phase 3 studies to evaluate the short-term safety and efficacy of two concentrations of REMURA(TM) (bromfenac ophthalmic solution for dry eye) in alleviating the signs and symptoms of dry eye disease. In the EAST study, REMURA was highly effective in treating a sign and symptom of dry eye but was not statistically significantly better than placebo in the entire patient cohort, a common outcome reported in studies testing other dry eye therapies. In both Phase 3 studies, safety data demonstrated REMURA was well-tolerated, with an adverse event profile similar to placebo and consistent with those observed previously with REMURA in a Phase 2 study and with other prescription dry eye drops. All three formulations were rated by patients as very comfortable.

"For the EAST study, we amended the statistical plan to focus on the subpopulation identified in the WEST study as responders. In the previously announced WEST study, the results showed a statistically significant improvement over placebo in the sign of conjunctival staining, as measured using the Lissamine Green (LG) Staining test, among female patients 51-70 years of age with moderate dry eye disease. However, the EAST study did not show a significant difference from placebo in this subpopulation, which we believe is partly due to the fact that the EAST study enrolled far fewer patients with mild to moderate dry eye disease," stated Timothy R. McNamara, Pharm.D., Vice President of Clinical Research and Medical Affairs of ISTA Pharmaceuticals. "We will complete a full analysis of the data, but focus our efforts on the potential use of the vehicle as an over-the-counter artificial tear product."

About the Phase 3 Study ISTA tested two concentrations of REMURA in two separate studies, known as EAST and WEST, conducted under a common protocol. Together, the studies enrolled 840 patients who were randomized on a 1:1:1 basis to receive one of the two bromfenac dose levels, or placebo, in both eyes, twice daily, for 42 days. A safety follow-up visit occurred 10 days after dosing ended. Originally approved under a Special Protocol Assessment (SPA), the studies had a co-primary endpoint requiring statistically significant differences in favor of REMURA compared to placebo in both one sign and one symptom of dry eye disease. The sign of conjunctival staining was measured using the LG Staining test, while the subjective symptoms were measured using the Ocular Surface Disease Index (OSDI)*, a validated 12-question survey used by patients to document symptoms.

To control for placebo responders in both trials, all patients entered a 14-day washout period prior to dosing, during which they used an over-the-counter (OTC) artificial tear. At the end of the 14-day washout period, only patients who had no change in a sign or symptom with the OTC artificial tear were randomized into one of three study arms. In analyzing the EAST study data, patients who used the OTC artificial tears four times daily showed no change in staining or symptoms after two weeks of OTC artificial tears therapy. As in the WEST study, those same dry eye patients who subsequently were treated with placebo twice daily in the EAST study had a statistically significant reduction in both staining and OSDI score versus baseline over two weeks of therapy.

ABOUT DRY EYE DISEASE Dry eye disease occurs when there is an imbalance of tears that provide moisture and lubrication to the eye, which can result in pain, itching, redness, blurry vision, light sensitivity and/or a gritty sensation or feeling of sand in the eye, all of which are related to localized inflammation of the ocular surface. Causes of dry eye include environmental conditions, such as air conditioning, smoke and dust, aging and menopause, side effects from antihistamines and birth control pills, Sjoegren's syndrome, rheumatoid arthritis and structural problems with the eyelid's ability to close. Left untreated, dry eye can lead to abrasions on the surface of the eye and damage to the cornea, potentially permanently affecting the ability to see. Current treatments include artificial tears and ointments, topical steroids, topical immunomodulators and punctal occlusion (closing or plugging of tear drains). Dry eye disease is a large and growing market, with 2011 worldwide prescription sales expected to be about $700 million.

ABOUT REMURA(TM) REMURA(TM) (bromfenac ophthalmic solution for dry eye) is a sterile, topical non-steroidal anti-inflammatory (NSAID) compound under investigation for use as an ophthalmic agent to alleviate the signs and symptoms of dry eye disease. ISTA acquired U.S. ophthalmic rights to bromfenac in May 2002 under a license from Senju Pharmaceuticals Co. Ltd. REMURA is an investigational drug and not yet available for commercial use.

ABOUT ISTA PHARMACEUTICALS ISTA Pharmaceuticals, Inc. is a fast growing and the third largest branded prescription eye care business in the United States, with an expanding focus on allergy therapeutics. ISTA currently markets four products, including treatments for ocular inflammation and pain post-cataract surgery, glaucoma and ocular itching associated with allergic conjunctivitis. The company's development pipeline contains additional candidates in various stages of development to treat dry eye, ocular inflammation and pain, and nasal allergies. Headquartered in Irvine, California, ISTA generated revenues of $156.5 million in 2010. For additional information about ISTA, please visit the corporate website at www.istavision.com .

* Ocular Surface Disease Index (OSDI) is a copyright Copyright 1995 of Allergan, Inc. REMURA(TM) (bromfenac ophthalmic solution for dry eye) is a trademark of ISTA Pharmaceuticals, Inc.

FORWARD-LOOKING STATEMENTS 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 additional data analysis and the potential of an over-the-counter artificial tear product 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 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, 2010, and Forms 10-Q for quarters ended March 31, and June 30, 2011.

 

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