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Lithera Receives Orphan Drug Product Designation For LIPO-102

Lithera has received orphan drug product designation for LIPO-102 for the treatment of symptomatic exophthalmos associated with thyroid-related eye disease.

LIPO-102 is a new, minimally-invasive, non-ablative approach to localised 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.

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.

John Wood, vice president of regulatory affairs and quality at Lithera, said:

“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.”