Sucampo Receives FDA Approval of sNDA for RESCULA

Sucampo Pharmaceuticals

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.