Tuesday, February 14, 2012

FDA Approves "New" Glaucoma Drug

"On Friday, the US Food and Drug Administration approved Merck's Zioptan, a once-daily preservative-free opthalmic solution of tafluprost, a prostaglandin analog for lowering high intra-ocular pressure in patients with open-angle glaucoma or with high intra-ocular pressure," according to a Medical News Today post. Read more. 

Merck reports that "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)." Read more.

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