Sucampo Pharmaceuticals Inc. (SCMP) is rising in value Wednesday morning on news that the Food and Drug Administration has approved the company’s supplemental new drug application for Rescula solution (unoprostone isopropyl), a treatment to lower intraocular pressure in patients suffering from open-angle glaucoma or ocular hypertension.
The Bethesda, Maryland-based company intends to commercialize Rescula in the first quarter of 2013. The approved product labeling reads that Rescula may be used as a first-line agent or concomitantly with other topical ophthalmic drug products to lower intraocular pressure, or IOP.
“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. 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,” said Dr. Ryuji Ueno, a man who wears man hats as Chief Executive Officer, Chairman and Chief Scientific Officer of Sucampo.
In April 2009, Sucampo acquired the rights to Rescula. The solution was originally approved by the FDA in 2000 for the lowering of IOP in open-angle glaucoma and ocular hypertension in patients who are intolerant of or insufficiently responsive to other IOP lowering medications.
Side effects of Rescula during clinical trials included burning/stinging, itching and dry eyes, amongst other things.
Open-angle glaucoma is one of the most prominent forms of glaucoma, affecting about three million Americans, but about 50 percent of the people are aware of it, according to The Eye Center.
In a healthy eye, a clear, nutrient-rich fluid called “aqueous humor” continuously drains from the pupil into the anterior chamber where it then exits into a channels and drains into blood vessels in the sclera (the white part of the eye). In open-angle glaucoma patients, the aqueous humor flows to slowly, creating pressure build-up inside the eye that can lead to degradation of nerve fibers vital for vision.
Shares of SCMP have traveled as high as $8.50 since beginning the year at $4.40. With Wednesday morning’s 5.8% climb so far, shares are ahead about 20 percent on the year.