DEC 13, 2012
Sucampo Pharmaceuticals, Inc. announced the FDA has approved Rescula (unoprostone isopropyl ophthalmic solution) 0.15% for lowering IOP in patients with open-angle glaucoma or ocular hypertension. The company plans to commercialize Rescula in the first quarter of 2013.
Rescula reduces IOP by increasing trabecular flow. According to the approved product labeling, it may be used as a first-line agent or concomitantly with other topical ophthalmic drugs.
Rescula was originally approved by the FDA in 2000 for the lowering of IOP in open-angle glaucoma and ocular hypertension patients intolerant of or insufficiently responsive to other IOP lowering medications. In April 2009, Sucampo acquired the U.S. and Canadian commercialization rights to Rescula from R-Tech Ueno, Ltd.