IRVINE, CA--(Marketwire -07/28/11)- ISTA Pharmaceuticals, Inc. (NASDAQ: ISTA - News), today announced top-line results from the first of its two Phase 3 studies to evaluate the short-term safety and efficacy of two concentrations of REMURA™ (bromfenac ophthalmic solution for dry eye) in alleviating the signs and symptoms of dry eye disease. The company's Phase 3 safety and efficacy program, which consists of two studies known as EAST and WEST, is being conducted under a Special Protocol Assessment (SPA) agreed upon with the U.S. Food and Drug Administration (FDA). Today's top-line results are from the WEST study; the EAST study is now fully enrolled and the Company expects to announce top-line results from the EAST study during fourth quarter of 2011.
According to preliminary analysis of the top-line results from the WEST study, while REMURA was highly effective in treating a sign and symptom of dry eye, it was not statistically significantly better than placebo, a common outcome reported in studies testing other dry eye therapies. From baseline, both concentrations of REMURA and the placebo showed highly statistically significant improvement (p < 0.0001) in one sign and one symptom. The co-primary end-points identified in the SPA require REMURA to achieve a statistically significant difference from placebo, not baseline, which was not achieved in the WEST Study.
In analyzing the patient data, the higher concentration of REMURA achieved statistical significance against placebo in the sign of conjunctival staining as measured using the Lissamine Green (LG) Staining test among a sub-population of female patients 51-70 years of age with moderate dry eye disease. 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.
"Consistent with our Phase 2 Study data, today's results show REMURA has a significant impact on the signs and symptoms of dry eye when compared to baseline. Since REMURA did not meet its co-primary end points in the WEST study, armed with this data, we expect to amend the statistical plan to appropriately focus the EAST study," stated Timothy R. McNamara, Pharm.D., Vice President of Clinical Research and Medical Affairs of ISTA Pharmaceuticals. "The EAST study is now fully enrolled, but the database has not been locked. We continue to analyze the WEST data, and once we see the data from the EAST Study, which we plan to announce in the fourth quarter, we'll make decisions about future development plans."
About the Phase 3 Study
ISTA is testing two concentrations of REMURA in two separate studies, known as EAST and WEST, conducted under a common protocol. Together, the studies are designed to enroll a total of approximately 1,000 patients with mild or moderate dry eye disease, 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. To establish efficacy, this study has 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 is being measured using the Lissamine Green (LG) Staining test, while the subjective symptoms are being measured using the Ocular Surface Disease Index (OSDI)*, a validated 12-question survey used by patients to document symptoms. The WEST study enrolled a total of 420 patients, 140 in each of the three arms.
To control for placebo responders in the trial, 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 then randomized into one of three study arms. In analyzing the data, patients who enrolled with severe dry eye and used the OTC artificial tears four times daily, showed no change in staining or symptoms after two weeks of therapy. Of those same severed dry eye patients that were subsequently treated with placebo twice daily, a statistically significant reduction in both staining and OSDI score versus baseline was observed over two weeks of therapy.
ISTA will host a conference call with a simultaneous webcast today, July 28, 2011, at 4:30 PM Eastern Time, to discuss the preliminary Phase 3 data for the REMURA dry eye WEST study and its second quarter 2011 results. To access the live conference call, U.S. and Canadian participants may dial 866-804-6922; international participants may dial 857-350-1668. The access code for the live call is 73568588. 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 37743515. This conference call also will be webcast live and archived on ISTA's website for 30 days at http://www.istavision.com.
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, Sjögren's syndrome, rheumatoid arthritis and structural problems with the eye lid's ability to close. Left untreated, dry eye can lead to abrasions on the surface of the eye and damage to the cornea, potentially affecting the ability to see permanently. 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 BROMFENAC OPHTHALMIC SOLUTION
REMURA™ (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.
ABOUT ISTA PHARMACEUTICALS
ISTA Pharmaceuticals, Inc. is a fast growing and the fourth 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 © 1995 of Allergan, Inc.
REMURA™ (bromfenac ophthalmic solution for dry eye) is a trademark of ISTA Pharmaceuticals, Inc.
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 the announcement of additional Phase 3 results from the EAST study and changes to statistical plan for the EAST study 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 Form 10-Q for the first quarter ended March 31, 2011.