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ISTA Pharmaceuticals Initiates Phase 3 Clinical Program for REMURA™ in Dry Eye Disease
Date:9/16/2010

ndomized at a ratio of 1:1:1 to receive either bromfenac or placebo in both eyes twice daily and will be evaluated over the course of 42 days.  For both efficacy studies, the objective sign of conjunctival staining will be measured using the Lissamine Green test and subjective symptoms will be measured using the Ocular Surface Disease Index (OSDI). ISTA anticipates reporting results in the middle of 2011.  

The two remaining Phase 3 safety studies are the subject of additional SPAs currently under review by the FDA. To meet FDA guidance on drugs for chronic dosing, the Company expects to conduct both a six-month and a twelve-month safety study. ISTA anticipates it will initiate one or both of these safety studies later this year, subject to reaching agreement with the FDA on the SPAs.

ABOUT DRY EYE DISEASE

Dry eye occurs when there is an imbalance of tears that provides 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.  Causes for dry eye include environmental conditions such as air conditioning, smoke and dust, aging and menopause, side-effects from antihistamines and birth control pills, Sjogren'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. Current treatments include artificial tears and ointments, topical steroids, a topical immunomodulator that is the only approved prescription eye drop treatment and punctal occlusion (closing or plugging of tear drains).  

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. Since 2
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SOURCE ISTA Pharmaceuticals, Inc.
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