Medication Monitor

Generic Name (Trade Name—Company)
February 13, 2012


New drug reduces intraocular pressure


Management of open-angle glaucoma and ocular hypertension

Merck announced the FDA approval of tafluprost ophthalmic solution 0.0015%, a preservative-free prostaglandin analog ophthalmic solution for reducing elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Approval was based on efficacy and safety results from five controlled clinical studies of as long as 2 years in 905 patients. Tafluprost, dosed once daily in the evening, lowered IOP at 3 and 6 months by 6–8 mm Hg and 5–8 mm Hg, respectively, from a baseline pressure of 23–26 mm Hg.

The most common pooled adverse reaction observed with tafluprost was conjunctival hyperemia, reported in 4% to 20% of patients. As with other ocular prostaglandin products, tafluprost may gradually change length, color, thickness, shape, and number of eyelashes and vellus hair in the treated eye. These changes are usually reversible upon discontinuation of treatment.

The product is expected to be available in March.