(By Balaseshan) Sucampo Pharmaceuticals Inc. (NASDAQ: SCMP) said it has received U.S. regulatory approval of a supplemental New Drug Application (sNDA) for Rescula (unoprostone isopropyl) to lower intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
Sucampo intends to commercialize Rescula in the first quarter of 2013. Open-angle glaucoma is the most common form of glaucoma.
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.
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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.
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).
SCMP closed Tuesday's regular session up 6.65% at $4.97. The stock has been trading between $3.78 and $8.50 for the past 52 weeks.