Monday, February 13, 2012

Merck's Good News Monday -- Zioptan™ (Tafluprost, Ophthalmic Solution) Approved

FDA has approved Merck's newest glaucoma treatment, per a Whitehouse Station press release:

. . . .Merck, known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved Zioptan™ (tafluprost ophthalmic solution) 0.0015%, the first 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. Open-angle glaucoma is the most common form of glaucoma, while ocular hypertension is a condition characterized by an increase in 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," said George L. Spaeth, M.D., Wills Eye Institute, Philadelphia, "I anticipate using Zioptan in many of these patients in my practice."

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.

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 was shown to have powerful IOP-lowering effects. In clinical studies of up to two years in duration, Zioptan, dosed once-daily in the evening lowered IOP at 3 and 6 months by 6-8 mmHg and 5-8 mmHg respectively, from a baseline pressure of 23-26 mmHg (mmHg = millimeters of mercury, a measurement of fluid pressure in the eye). . . .

Good news -- but do see the side-effects/risk information, for prospective patients -- and do talk to your doctor. [This site is in no manner affiliated with the doctor(s) quoted, nor Merck itself. End, FDA disclaimer.]


Anonymous said...

2.2 million Americans have glaucoma, but only 1.1 million know they have it.

Additionally, it is a far more common affliction in people of color -- specifically, of African ancestry, than in Caucasians. Glaucoma is five times more common in African-Americans than Caucasians. Even so, glaucoma results in about 7 million doctor visits in the US, each year.

Given the disparity in health care coverage between these classes of people, it is possible that Merck's new treatment will max out at under $400 million per year in US revenue.

We will need wait and to see (facts and figures above -- from this non-profit glaucoma site).

Anonymous said...

It is also true that Zioptan will face many generic competitors, not least of which will be the generic versions of Truspot and Cosopt, legacy Schmerck products.