For patients with elevated intraocular pressure (IOP) in open-angle glaucoma (OAG) or ocular hypertension (OHT)

Substantial IOP lowering was demonstrated throughout the day1

In a 12-week, randomized, double-masked, active-controlled, multicenter study of ZIOPTAN and preservative-free timolol (per protocol population)

Enlarge Chart Reference

Study Design

Patients with primary OAG, pigmentary glaucoma, pseudoexfoliative glaucoma, or OHT were randomized to treatment with ZIOPTAN once daily (with preservative-free vehicle to match) or preservative-free timolol twice daily for 12 weeks. The primary hypothesis was that the efficacy of once-daily ZIOPTAN would be noninferior to twice-daily timolol over 12 weeks of treatment. The efficacy analysis was based on the per protocol population that included patients who received at least 1 dose of study treatment, had at least 1 efficacy measurement available for the analysis endpoint, and did not commit any protocol violations expected to substantially alter efficacy results. The primary efficacy endpoint was the change from baseline in mean IOP at 9 time points.

aDose administered at 8 PM.

Mean baseline IOP for ZIOPTAN (n=299): 26.1 mmHg at 8 AM, 24.8 mmHg at 10 AM, 23.8 mmHg at 4 PM.

Mean baseline IOP for preservative-free timolol (n=313): 26.0 mmHg at 8 AM, 24.6 mmHg at 10 AM, 23.5 mmHg at 4 PM.

Percent reductions for preservative-free timolol—week 2: 26%, 25%, 22%; week 6: 28%, 27%, 23%; and week 12: 29%, 27%, 24% at 12, 14, and 20 hours postdose, respectively.

Approximately 1% discontinuation rate due to adverse events

Reference: 1. Data available on request from Merck, Professional Services-DAP, WP1-27, PO Box 4, West Point, PA 19486-0004. Please specify information package OPHT-1027523-0000.

ZIOPTAN is indicated for reducing elevated IOP in patients with OAG or OHT.

SELECT IMPORTANT SAFETY INFORMATION

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. After discontinuation of ZIOPTAN, pigmentation of the iris is likely to be permanent, while pigmentation of the periorbital tissue and eyelash changes have 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. While treatment with ZIOPTAN can be continued in patients who develop noticeably increased iris pigmentation, 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 on discontinuation of treatment.

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

Macular edema, including cystoid macular edema, has been reported during treatment with prostaglandin F2α analogs. 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.

Before prescribing ZIOPTAN, please read the Prescribing Information.