FDA approves new glaucoma drug
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 tafluprost 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. Tafluprost, dosed once-daily in the evening, lowered IOP at 3 and 6 months by 6–8 mmHg (mmHg = millimeters of mercury, a measurement of fluid pressure in the eye) and 5–8 mmHg respectively, from a baseline pressure of 23–26 mmHg.
Side effects include changes to pigmented tissues, including increased coloring in the iris, eyelid and eyelashes. Iris color is likely to remain altered after discontinuing the drug, whereas discoloration of other tissues has been reversible in at least some patients. Eyelashes and vellus hairs around the eye may also become longer, thicker and more numerous.
Serious adverse effects reported with tafluprost include macular edema and exacerbations of preexisting inflammation. Because of this, the drug should be used with caution in patients with active intraocular inflammation, in aphakic patients, in pseudophakic patients with a torn posterior lens capsule and in patients with known risk factors for macular edema, the manufacturer warned.
The most common adverse event was conjunctival hyperemia, reported in 4% to 20% of patients in clinical trials.
Tafluprost is expected to be available in March. For more information, call (800) 672-6372 or visit www.merck.com.