Merck announced that the FDA has approved Zioptan (tafluprost ophthalmic solution) 0.0015%, a preservative-free prostaglandin analog ophthalmic solution, for reducing elevated intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension.
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, dosed once-daily in the evening, lowered IOP at 3 and 6 months by 6–8mmHg and 5–8mmHg respectively, from a baseline pressure of 23–26mmHg (mmHg = millimeters of mercury, a measurement of fluid pressure in the eye).
Zioptan is expected to be available in March.
For more information, call (800) 672-6372 or visit www.merck.com.