Pharmaceutical Business review

Merck receives FDA approval for prostaglandin analog ophthalmic solution

ZIOPTAN (pronounced zye-OP-tan) is approved 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, the company said.

Both preservative-containing and preservative-free formulations of tafluprost were used in these clinical studies.

Merck expects to launch ZIOPTAN in March 2012.

Merck Research Laboratories neurology and ophthalmic therapeutic area vice president David Michelson said that ZIOPTAN is the first preservative-free prostaglandin analog.