The FDA has approved Rescula (unoprostone isopropyl ophthalmic solution, Sucampo Pharmaceuticals Inc.) 0.15%, an sNDA for lowering IOP in patients with open-angle glaucoma or ocular hypertension.
Sucampo Pharmaceuticals Inc. announced it has received approval from the U.S. Food and Drug Administration (FDA) 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.
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,” said Ryuji Ueno, MD, PhD, chairman, chief executive officer, and chief scientific officer of Sucampo. “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.”