Sucampo Pharma gets US nod for RESCULA®
Sucampo Pharmaceuticals, Inc has secured approval of an sNDAfor RESCULA® (unoprostone isopropyl ophthalmic solution) (unoprostone isopropyl ophthalmic solution) 0.15% to lower intraocular pressure in patients with open-angle glaucoma or ocular hypertension from the U.S. Food and Drug Administration.
The open-angle glaucoma is the most common form of glaucoma and Sucampo aims to commercialize RESCULA in the first quarter of 2013.
As per the approved product labeling, RESCULA will be used as a first-line agent or concomitantly with other topical ophthalmic drug products to lower intraocular pressure.
RESCULA is a big potassium channel activator that is different from other IOP lowering agents. Ryuji Ueno, Chairman and Chief Executive Officer and Chief Scientific Officer at Sucampo said, “Rescula provides IOP production by increasing trabecular flow, and may be an appropriate choice for eye specialists who are trying to balance efficacy with management of side effects. “ He also said, “It has been shown to be an effective medicine in lowering IOP patients with open-angle glaucoma and ocular hypertension while demonstrating an excellent systematic safety profile and an established ocular side effects profile.”
Rescula was originally approved by FDA in 2000 to lower IOP in open-angle glaucoma and ocular hypertension in patients who are intolerant or not responsive to other IOP lowering medications.
Sucampo is a global pharmaceutical company focused on developing and commercializing medicines based on prostones, to meet the unmet medical needs of patients on global basis.
