FDA approves tafluprost for lowering IOP

Whitehouse Station, NJ-The FDA has approved tafluprost ophthalmic solution 0.0015% (Zioptan, Merck), a preservative-free prostaglandin analog, for reducing elevated IOP in patients with open-angle glaucoma or ocular hypertension.

The agency based its approval on efficacy and safety results from five controlled clinical studies in a total of 905 patients. In the studies, of up to 2 years in duration, tafluprost dosed once daily in the evening lowered IOP at 3 and 6 months by 6 to 8 mm Hg and 5 to 8 mm Hg, respectively, from a baseline IOP of 23 to 26 mm Hg. Both preservative-containing and preservative-free formulations of tafluprost were used in the clinical studies.

“Prostaglandin analogs are often used as a first line of treatment to lower IOP in patients with open-angle glaucoma,” said George L. Spaeth, MD, of the Wills Eye Institute, Philadelphia. “The approval of [tafluprost ophthalmic solution] will provide a new, effective option to lower IOP. I anticipate using [tafluprost] in many of these patients in my practice.”

Merck anticipates that tafluprost will be available to customers next month.

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