The FDA has approved Zioptan (tafluprost 0.0015%, Merck), the first preservative-free prostaglandin analog. Zioptan is indicated for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

Its approval was based on efficacy and safety results from five controlled clinical studies in 905 patients, using both preservative-containing and preservative-free formulations.

These studies showed that Zioptan, dosed once daily in the evening, lowered IOP by 6mm to 8mm Hg at three months and by 5mm to 8mm Hg at six months, from a baseline pressure of 23mm to 26mm Hg

Use of Zioptan may gradually change eyelashes in the treated eye, Merck noted. Changes include increased length, color, thickness, shape and number of lashes—these are usually reversible upon discontinuation of treatment. Other common side effects include increased pigmentation of the iris and redness in the eyes.

Merck expects Zioptan will be available in March, and will cost $97 for a 30-day supply.