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Optimized Triamcinolone Formulation Developed for Ocular Use
IRVINE, CA, USA | June 16, 2008 | Allergan, Inc. (NYSE: AGN) today announced that the U.S. Food and Drug Administration (FDA) has approved TRIVARIS(TM) (triamcinolone acetonide injectable suspension) 80 mg/mL, a synthetic glucocorticoid corticosteroid with anti-inflammatory action. Delivered via intravitreal injection, the ophthalmic indications for TRIVARIS(TM) include sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. These are inflammatory conditions that can result in vision loss.
"Retinal diseases are currently the leading cause of blindness in developed countries and represent a significant unmet need in eye care," said Scott Whitcup, M.D., Allergan's Executive Vice President, Research and Development. "TRIVARIS(TM) marks the first approval for Allergan resulting from our strategic focus on the development of therapies for back-of-the-eye diseases, and we remain committed to bringing forth innovative new treatments for patients suffering from retinal diseases."
Important Safety Information
Prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections.
The use of oral corticosteroids is not recommended in the treatment of optic neuritis and may lead to an increase in the risk of new episodes.
Intraocular pressure may become elevated in some individuals. If steroid therapy is continued for more than 6 weeks, intraocular pressure should be monitored.
Corticosteroids should be used cautiously in patients with a history of ocular herpes simplex because of possible corneal perforation. Corticosteroids should not be used in active ocular herpes simplex.
Full prescribing information is available at www.allergan.com.
About Allergan, Inc.
Founded in 1950, Allergan, Inc., with headquarters in Irvine, California, is a multi-specialty health care company that discovers, develops and commercializes innovative pharmaceuticals, biologics and medical devices that enable people to live life to its greatest potential - to see more clearly, move more freely, express themselves more fully. The Company employs approximately 8,000 people worldwide and operates state-of-the-art R&D facilities and world-class manufacturing plants. In addition to its discovery-to-development research organization, Allergan has global marketing and sales capabilities with a presence in more than 100 countries.
SOURCE: Allergan Inc. |
