This article is more than 5 years old. Information may no longer be current.
FDA approves Zioptan for glaucoma, ocular hypertension
Click Here to Manage Email Alerts
The U.S. Food and Drug Administration has approved a preservative-free prostaglandin analogue ophthalmic solution from Merck.
Zioptan (tafluprost ophthalmic solution 0.0015%) can be used to reduce elevated IOP in patients with ocular hypertension or open-angle glaucoma, according to a company press release.
The approval is the first ophthalmic nod in 2012 and the first for a brand drug for glaucoma indications since 2001.
“The benefit of having a preservative-free formulation is that you take the ocular surface effect of [benzalkonium chloride] out of the equation,” Malik Y. Kahook, MD, told Ocular Surgery News. “Ocular surface disease has a higher prevalence in patients who have glaucoma who are on topical therapy.”
The approval comes after five controlled clinical studies analyzed 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 may cause increased pigmentation of the iris, periorbital tissue and eyelashes, according to the release.
Reference:
- FDA approved drugs for ophthalmology. CenterWatch website. http://www.centerwatch.com/drug-information/fda-approvals/drug-areas.aspx?AreaID=13. Accessed Feb. 15, 2012.
- Disclosure: Dr. Kahook has consulted for and received research funding from Merck.
