Regulatory Affairs

Merck receives FDA approval for prostaglandin analog ophthalmic solution

PBR Staff Writer Published 15 February 2012

Merck, known as MSD outside the US and Canada, has received FDA approval for ZIOPTAN (tafluprost ophthalmic solution) 0.0015%, the preservative-free 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.