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Sucampo Announces FDA Approval Of An SNDA For RESCULA® (unoprostone Isopropyl)

Stocks in this article: SCMP

Sucampo Pharmaceuticals, Inc. (“Sucampo” or “the Company”) (NASDAQ: SCMP) today announced that it has received approval of an sNDA for RESCULA ® (unoprostone isopropyl ophthalmic solution) 0.15% for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension from the U.S. Food and Drug Administration (FDA). Open-angle glaucoma is the most common form of glaucoma. Sucampo intends to commercialize RESCULA in the first quarter of 2013.

According to the approved product labeling, RESCULA may be used as a first-line agent or concomitantly with other topical ophthalmic drug products to lower intraocular pressure. RESCULA is a BK (Big Potassium) channel activator, which is different from other IOP lowering agents.

“RESCULA provides IOP reduction by increasing trabecular flow, and may be an appropriate choice for eye specialists who are trying to balance efficacy with management of side effects. It has been shown to be an effective medicine in lowering IOP in patients with open-angle glaucoma and ocular hypertension while demonstrating an excellent systemic safety profile and an established ocular side effects profile,” said Ryuji Ueno, M.D., Ph.D., Ph.D., Chairman, Chief Executive Officer, and Chief Scientific Officer of Sucampo.

About Unoprostone Isopropyl (RESCULA)

Unoprostone isopropyl is a member of Sucampo’s family of prostones and is a synthetic docosanoid. Unoprostone isopropyl may have a local effect on BK (Big Potassium) channels in the eye. BK channels are expressed in contractile tissues like the trabecular meshwork. RESCULA may reduce elevated intraocular pressure (IOP) by increasing the outflow of aqueous humor through the trabecular meshwork. Complete details of the mechanism of action are unknown at this time.

RESCULA was originally approved by the FDA in 2000 for the lowering of IOP in open-angle glaucoma and ocular hypertension in patients who are intolerant of or insufficiently responsive to other IOP lowering medications. In April 2009, Sucampo acquired the commercialization rights to RESCULA for the United States and Canada from R-Tech Ueno, Ltd. (RTU).

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