FDA Approves sNDA for Rescula Ophthalmic Solution

Sucampo announced that it has received approval of an sNDA for Rescula (unoprostone isopropyl ophthalmic solution) 0.15% for the lowering of intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Rescula is already approved for use as a first-line agent or concomitantly with other topical ophthalmic drug products to lower intraocular pressure.

Rescula, a synthetic docosanoid, activates the big potassium (BK) channels that are expressed in contractile tissues like the trabecular meshwork. This provides intraocular pressure reduction by increasing the outflow of aqueous humor through the trabecular meshwork.

Rescula ophthalmic solution will be available in the first quarter of 2013.

For more information call (301) 961-3400 or visit www.sucampo.com.