FDA OKs First Preservative-Free Prostaglandin Eye Drops

Yael Waknine


February 15, 2012

February 15, 2012 — The US Food and Drug Administration (FDA) has approved 0.0015% (15 μg/mL) tafluprost (Zioptan, Merck, under license from Santen Pharmaceutical Co, Ltd) as the first preservative-free prostaglandin analog ophthalmic solution for reducing elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

All currently available products contain benzalconium chloride, including travoprost (Travatan, Alcon Pharmaceuticals, Ltd and generics), latanoprost (Xalatan, Pfizer, Inc and generics), and bimatoprost (Lumigan, Allergan).

"The prostaglandin class has proven over the last 15 years to be very effective and well tolerated, [but] some patients have issues with preservatives and [are] unable to tolerate preserved medications," Jonathan Myers, MD, associate attending surgeon in the glaucoma service at Wills Eye Institute, Philadelphia, Pennsylvania, told Medscape Medical News, noting that the elderly, who are at greatest risk for glaucoma, are more likely to be affected by ocular surface disease.

"Patients with ocular surface disease often do better with nonpreserved medications, as preservatives may exacerbate the signs and symptoms of [the condition]," he emphasized.

FDA approval was based on data from 5 controlled clinical studies of up to 2 years in length in 905 patients dosed once daily with 0.3 mL (4.5 μg) tafluprost in the evening; both preservative-containing and preservative-free formulations were used.

Results showed that tafluprost therapy significantly decreased IOP by 6 to 8 mmHg and 5 to 8 mmHg from an average baseline of 23 to 26 mmHg at 3 and 6 months, respectively.

Prostaglandin Drops: Class Effects

As with other prostaglandin analogs, treatment with tafluprost has been associated with a permanent darkening of the iris, as well as potentially reversible increase in eyelid pigmentation and increased eyelash length, color, thickness, shape, and number. The latter effect has been exploited in the marketing of bimatoprost (Latisse, Allergan) to treat eyelash hypotrichosis.

Prostaglandin analogs such as tafluprost have also been linked to reports of macular edema, including cystoids macular edema. Caution is advised when treating patients with aphakia, pseudophakic patients with a torn posterior lens capsule, and those with known risk factors for macular edema. Patients with active ocular inflammation, such as uveitis or iritis may experience an exacerbation of the condition.

Previously approved for use in the European Union, South America, Africa, the Middle East, India, and Australia (Taflotan/Tapros/Saflutan, Santen Pharma), tafluprost is expected to be available in the United States by March 2012. It will be supplied in foil pouches that must be stored in the refrigerator until opened; once opened, the 10 single-use vials included may be kept at room temperature for up to 28 days.

Dr. Myers has disclosed having received research grants and speaking fees from Merck, as well as receiving grants and speaking fees from their direct competitors, Alcon and Allergan.


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