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FDA approves Zioptan
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WHITEHOUSE STATION, N.J. — Merck received approval from the U.S. Food and Drug Administration for a preservative-free prostaglandin analogue ophthalmic solution, according to a release from the company.
Zioptan (tafluprost ophthalmic solution 0.0015%) can be used to reduce elevated IOP in patients with ocular hypertension or open-angle glaucoma, the release said.
The approval comes after five controlled clinical studies analyzing the drug's safety and efficacy in 905 patients for up to 2 years, according to the release.
The studies showed that a once-daily evening dosage lowered IOP by 6 mm Hg to 8 mm Hg at 3 months and 5 mm Hg to 8 mm Hg at 6 months, the release said.
Tafluprost ophthalmic solution was also found to cause increased pigmentation of the iris, periorbital tissue and eyelashes. Changes to iris pigmentation are likely to be permanent, but pigmentation of the periorbital tissue and eyelash changes may be reversible in some patients after discontinuation of the medication, according to the release.
The treatment should be available to consumers in March, the release said.