FDA approves preservative-free solution for glaucoma, ocular hypertension

February 14, 2012

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

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

Open-angle glaucoma is the most common form of glaucoma; ocular hypertension is a condition characterized by increased pressure inside the eye.

"Prostaglandin analogs are often used as a first-line of treatment to lower intraocular pressure in patients with open-angle glaucoma. The approval of Zioptan will provide a new, effective option to lower IOP," George L. Spaeth, MD, Wills Eye Institute, Philadelphia, said in a company press release. "I anticipate using Zioptan in many of these patients in my practice."

FDA approval of Zioptan was based on efficacy and safety results from 5 controlled clinical studies of up to 2 years in 905 patients. Both preservative-containing and preservative-free formulations of tafluprost were used in these clinical studies.

Zioptan was shown to have IOP-lowering effects. In clinical studies of up to 2 years, Zioptan, dosed once-daily in the evening, lowered IOP at 3 and 6 months by 6 mmHg to 8 mmHg and 5 mmHg to 8 mmHg, respectively, from a baseline pressure of 23 mmHg to 26 mmHg.

Zioptan has been reported to cause changes to pigmented tissues. The most frequently reported changes have been increased pigmentation of the iris, periorbital tissue (eyelid) and eyelashes.

Pigmentation is expected to increase as long as Zioptan is administered, according to the press release from Merck. After discontinuation of Zioptan, pigmentation of the iris is likely to be permanent but pigmentation of the periorbital tissue has been reported to be reversible in some patients.

Patients who receive treatment should be informed of the possibility of increased pigmentation. The long-term effects of increased pigmentation are not known. Iris color change may not be noticeable for several months to years.

Treatment with Zioptan can be continued in patients who develop noticeably increased iris pigmentation, but these patients should be examined regularly.

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.

Zioptan should be used with caution in patients with active intraocular inflammation (eg, iritis/uveitis) because the inflammation may be exacerbated.

Macular edema, including cystoid macular edema, has been reported during treatment with prostaglandin F2α analogs, the press release also said. Zioptan should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema.

In clinical trials of patients receiving either preservative-containing or preservative-free Zioptan, the most common pooled adverse reaction observed was conjunctival hyperemia which was reported in a range of 4% to 20% of patients.

There are no adequate and well-controlled studies in pregnant women. Zioptan should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus.