FDA Approves New Open-Angle Glaucoma Treatment

On February 10, 2012, the FDA approved Zioptan (tafluprost ophthalmic solution) 0.0015%, the first preservative-free prostaglandin analog on the market to reduce elevated intraocular pressure (IOP) in people with open-angle glaucoma, an eye disease that increases in incidence with age. Zioptan is also approved to treat ocular hypertension, an important risk factor for glaucoma and the second leading cause of blindness in the United States.

“Prostaglandin analogs are often used as a first line of treatment to lower intraocular pressure in patients with open-angle glaucoma. The approval of Zioptan will provide a new, effective option to lower IOP,” said George L. Spaeth, MD, Wills Eye Institute, Philadelphia, PA, in a press release by Merck, the drug’s manufacturer. “I anticipate using Zioptan in many of these patients in my practice,” he added.

Zioptan is an eye drop that should be used once daily in the evening. It may be used alone or in combination with other topical ophthalmic drug products to lower IOP; however, each agent should be administered at least 5 minutes apart.

The FDA approved Zioptan based on its demonstrated safety and efficacy in five controlled clinical studies that lasted up to 2 years and included 905 patients. In the studies, patients with open-angle glaucoma or ocular hypertension treated with Zioptan in the evening demonstrated a reduction in IOP of 6 to 8 mm Hg at 3 months and of 5 to 8 mm Hg at 6 months. These patients had a baseline IOP of 23 to 26 mm Hg.

In clinical trials, the most common adverse effect of treatment was conjunctival hyperemia, which occurred in 4% to 20% of patients. Other side effects included permanent darkening of the iris; potentially reversible darkening of the eyelid; and gradual changes in eyelashes and vellus hair in the treated eye, including increased length, color, thickness, shape, and number of hairs and lashes, but these changes were usually reversible upon discontinuation of treatment.