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FDA approves preservative-free Merck drug to lower IOP

April 26, 2012

Merck announced the U.S. Food and Drug Administration (FDA) approved Zioptan™ (tafluprost ophthalmic solution) 0.0015%, the first preservative-free prostaglandin analog ophthalmic solution. Zioptan is approved for reducing elevated intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension.

“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 to 8mmHg and 5 to 8mmHg, respectively, from a baseline pressure of 23 to 26mmHg.

“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 this month.

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