SAN DIEGO, Calif., Feb. 23, 2010 (GLOBE NEWSWIRE) -- Lithera, Inc. today announced the receipt of Orphan Drug Product Designation for LIPO-102 for the treatment of symptomatic exophthalmos associated with thyroid-related eye disease, a rare disease affecting less than 200,000 persons in the United States. Thyroid-related eye disease is a two-phase autoimmune condition; inflammation and progressive expansion of the orbital connective tissues (muscle and fat) give way to chronic, stable disease characterized by irreversible fat expansion that can result in exophthalmos (protrusion of the eye from the orbit) and its associated clinical consequences. Therapy for this latter stage currently is limited to surgical decompression. LIPO-102 is a novel, minimally-invasive, non-ablative approach to localized fat reduction comprising an injectable aqueous combination of salmeterol xinafoate (SX) and fluticasone propionate (FP). Injection of LIPO-102 is intended to shrink the fat pushing the eye out of the orbit.
"LIPO-102 may offer a simple, non-invasive alternative to major surgery for patients with exophthalmos. Orphan designation will facilitate the development of LIPO-102 for these patients," said John F. Wood, Vice President of Regulatory Affairs and Quality at Lithera.
About LIPO-102
LIPO-102 is being developed as a first-in-class injectable drug product designed to produce local, selective fat tissue reduction (pharmaceutical lipoplasty). Using FDA-registered drugs approved for use in other indications, LIPO-102 targets and stimulates natural fat tissue metabolism to achieve non-ablative, non-surgical fat tissue reduction in specific locations. LIPO-102 is currently under development for the treatment of symptomatic exophthalmos (protrusion of the eye from the orbit) associated with thyroid-related eye disease (the thyroid condition is also known as Graves' Disease).
About Lithera
Lithera is a clinical stage company developing pharmaceutical and biomedical products addressing both medical and lifestyle indications in ophthalmology and aesthetic medicine. Our lead product candidate (LIPO-102) is a novel injectable pharmaceutical product designed to produce local, selective fat tissue reduction (pharmaceutical lipoplasty). Founded in 2007, the Company has assembled an exceptional team of senior executives, employees and advisors and has been financed by top-tier venture capital firms. For more information on Lithera, Inc., please visit www.lithera.com.
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