Merck's ZIOPTAN for reducing elevated IOP receives FDA approval

MerckFeb 13 2012

Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved ZIOPTAN^TM (tafluprost ophthalmic solution) 0.0015%, the first preservative-free prostaglandin analog ophthalmic solution. ZIOPTAN (pronounced zye-OP-tan) is approved for reducing elevated intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension. Open-angle glaucoma is the most common form of glaucoma, while ocular hypertension is a condition characterized by an increase in pressure inside the eye.

“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”

"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, M.D., Wills Eye Institute, Philadelphia, "I anticipate using ZIOPTAN in many of these patients in my practice."

ZIOPTAN may gradually change eyelashes and vellus hair in the treated eye. These changes include increased length, color, thickness, shape and number of lashes. Eyelash changes are usually reversible upon discontinuation of treatment.

The FDA approval of ZIOPTAN was based on efficacy and safety results from five controlled clinical studies of up to two years in 905 patients. Both preservative-containing and preservative-free formulations of tafluprost were used in these clinical studies.

ZIOPTAN was shown to have powerful IOP-lowering effects. In clinical studies of up to two years in duration, ZIOPTAN, dosed once-daily in the evening lowered IOP at 3 and 6 months by 6-8 mmHg and 5-8 mmHg respectively, from a baseline pressure of 23-26 mmHg (mmHg = millimeters of mercury, a measurement of fluid pressure in the eye).

"ZIOPTAN is the first preservative-free prostaglandin analog," said David Michelson, M.D., vice president, Neurology and Ophthalmic Therapeutic Area, Merck Research Laboratories. "We are excited to continue Merck's 50-year tradition of bringing forward additional options to help meet the needs of eye care professionals and their patients."

Merck anticipates that ZIOPTAN will be available to customers in March.