FDA Approves Drug for Glaucoma, Ocular Hypertension

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The pharmaceutical company Merck in Whitehouse Station, New Jersey says the Food and Drug Administration has approved its drug Zioptan to reduce elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Zioptan is the brand name for Merck’s tafluprost ophthalmic solution to reduce pressure inside the eye.

Glaucoma is the second most common cause of blindness in the U.S., with open-angle (chronic) glaucoma the most common type. The front part of the eye is filled with a clear fluid called aqueous humor that leaves the eye through channels in the front of the eye in an area called the anterior chamber angle, or the angle. Slowing or blocking the flow of aqueous humor will cause pressure, called intraocular pressure, to build up in the eye. When intraocular pressure is high, which often happens in glaucoma, it can cause damage to the optic nerve.

Merck says FDA approval of Zioptan was based on efficacy and safety results from clinical studies of up to two years in 905 patients. In the clinical studies, Zioptan, dosed once-daily in the evening, lowered intraocular pressure at three and six months by 6-8 millimeters of mercury (mmHg) and 5-8 mmHg respectively, from a baseline pressure of 23-26 mmHg. Millimeters of mercury (mmHG) is a measurement of fluid pressure in the eye.

Zioptan does not contain preservatives, and is thus a sterile solution for single use, with one container sufficient to treat one or both eyes. It may be used with other ophthalmic drugs, but if used with other topical ophthalmic drugs, they are recommended to be administered at least five minutes apart.

In the clinical trials, the most common adverse reaction observed was conjunctival hyperemia (“red eyes”), which was reported from 4 to 20 percent of patients. Zioptan has been reported to cause changes to pigmented tissues, particularly increased pigmentation of the iris, periorbital tissue (eyelid), and eyelashes.

Read more: Genes Associated with Glaucoma Identified

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