Authors of the posters were Simon P. Chandler, Ph.D., James A. Gow, M.D. and Timothy R. McNamara, Pharm.D. of ISTA Pharmaceuticals, Inc., Irvine, CA, USA; Sheri L. Rowen, M.D., of the Mercy Medical Eye and Cosmetic Surgery Center, Baltimore, MD, USA; and Neal A. Sher, M.D., F.A.C.S., Partner, Eye Care Associates, Minneapolis, MN, USA.
ISTA recently announced the Company has initiated its REMURA Phase 3 clinical study program. Two Phase 3 studies to evaluate the efficacy and safety of REMURA are being conducted under a Special Protocol Assessment (SPA) agreed upon with the U.S. Food and Drug Administration (FDA), and two remaining Phase 3 safety studies are the subject of additional SPAs currently under review by the FDA. ISTA anticipates starting the remaining safety studies later this year and reporting results for the first two Phase 3 efficacy and safety studies in the middle of 2011.
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 REMURA AND BROMFENAC OPHTHALMIC SOLUTION
|SOURCE ISTA Pharmaceuticals|
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