FDA approves preservative-free drug for glaucoma

NewsGuard 100/100 Score

The U.S. Food and Drugs Administration (FDA) has approved tafluprost ophthalmic solution (Zioptan, Merck) 0.0015%, the first preservative-free prostaglandin analog ophthalmic solution for glaucoma.

The drug acts by reducing elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Open-angle glaucoma is the most common form of glaucoma; ocular hypertension is a condition characterized by increased 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,” George L. Spaeth, Wills Eye Institute, Philadelphia, said in a company press release. “I anticipate using Zioptan in many of these patients in my practice.”

FDA approval of Zioptan was based on efficacy and safety results from 5 controlled clinical studies of up to 2 years in 905 patients. Both preservative-containing and preservative-free formulations of tafluprost were used in these clinical studies. Zioptan was shown to have IOP-lowering effects. In clinical studies of up to 2 years, Zioptan, dosed once-daily in the evening, lowered IOP at 3 and 6 months by 6 mmHg to 8 mmHg and 5 mmHg to 8 mmHg, respectively, from a baseline pressure of 23 mmHg to 26 mmHg.

In clinical trials of patients receiving either preservative-containing or preservative-free Zioptan, the most common pooled adverse reaction observed was conjunctival hyperemia which was reported in a range of 4% to 20% of patients.

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, according to the press release from Merck. After discontinuation of Zioptan, pigmentation of the iris is likely to be permanent but pigmentation of the periorbital tissue has 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.

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, the press release also said. There are no adequate and well-controlled studies in pregnant women. Zioptan should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus.

Merck expects Zioptan to become available to customers next month, priced at $97 for a 30-day supply, a company spokeswoman said. Zioptan enters a market with generic options. Pfizer Inc.'s Xalatan eye solution recently lost market exclusivity in major countries, clearing the way for cheaper generic copies. Merck also has older drugs designed to reduce intraocular pressure, Trusopt and Cosopt, which have lost market exclusivity in the U.S. and some other countries.

Dr. Ananya Mandal

Written by

Dr. Ananya Mandal

Dr. Ananya Mandal is a doctor by profession, lecturer by vocation and a medical writer by passion. She specialized in Clinical Pharmacology after her bachelor's (MBBS). For her, health communication is not just writing complicated reviews for professionals but making medical knowledge understandable and available to the general public as well.


Please use one of the following formats to cite this article in your essay, paper or report:

  • APA

    Mandal, Ananya. (2018, August 23). FDA approves preservative-free drug for glaucoma. News-Medical. Retrieved on April 18, 2024 from https://www.news-medical.net/news/20120215/FDA-approves-preservative-free-drug-for-glaucoma.aspx.

  • MLA

    Mandal, Ananya. "FDA approves preservative-free drug for glaucoma". News-Medical. 18 April 2024. <https://www.news-medical.net/news/20120215/FDA-approves-preservative-free-drug-for-glaucoma.aspx>.

  • Chicago

    Mandal, Ananya. "FDA approves preservative-free drug for glaucoma". News-Medical. https://www.news-medical.net/news/20120215/FDA-approves-preservative-free-drug-for-glaucoma.aspx. (accessed April 18, 2024).

  • Harvard

    Mandal, Ananya. 2018. FDA approves preservative-free drug for glaucoma. News-Medical, viewed 18 April 2024, https://www.news-medical.net/news/20120215/FDA-approves-preservative-free-drug-for-glaucoma.aspx.


  1. mesfin mesfin United States says:

    I am using Lumigan for my Glaucoma but my doctor is considering Laser surgey to lower the IOP in bort eyes (23-26).Can to to her to try this new medication before anything. What are the serious side effects this medication may have except the pigmentation etc.Please help

The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
Post a new comment

While we only use edited and approved content for Azthena answers, it may on occasions provide incorrect responses. Please confirm any data provided with the related suppliers or authors. We do not provide medical advice, if you search for medical information you must always consult a medical professional before acting on any information provided.

Your questions, but not your email details will be shared with OpenAI and retained for 30 days in accordance with their privacy principles.

Please do not ask questions that use sensitive or confidential information.

Read the full Terms & Conditions.

You might also like...
Feeling lonely? It may affect how your brain reacts to food, new research suggests