FDA approves tafluprost

March 1, 2012
Cheryl Guttman Krader, BS, Pharm

On Feb. 13, Merck announced that it received approval from the FDA to market its one-of-a-kind, preservative-free, prostaglandin analog, tafluprost ophthalmic solution 0.0015%, for lowering IOP in patients with open-angle glaucoma or ocular hypertension.

Key Points

Whitehouse Station, NJ-On Feb. 13, Merck announced that it received approval from the FDA to market its one-ofa-kind, preservative-free, prostaglandin analog, tafluprost ophthalmic solution 0.0015% (Zioptan), for lowering IOP in patients with open-angle glaucoma or ocular hypertension.

According to glaucoma specialist George L. Spaeth, MD, the commercial availability of this unique prostaglandin analog formulation is an important advance in patient care.

Preservative-free tafluprost has been commercially available outside of the United States since 2008.

The decision of the FDA to grant marketing clearance in the United States was based on a submission package with data from five controlled clinical studies, including some with U.S. centers, and investigating both preservative-containing and preservative-free formulations of tafluprost. Overall, the trials included 905 patients treated with tafluprost for up to 2 years.

Results were recently published from a randomized, double-masked, 12-week clinical trial that established the non-inferiority of preservative-free tafluprost 0.0015% dosed once daily to preservative-free timolol 0.5% administered twice daily [Am J Ophthalmol. 2012 Feb. 4. Epub ahead of print]. The study randomly assigned 643 patients with IOP between 23 and 36 mm Hg. Mean diurnal IOP at baseline in the tafluprost group was 24.9 mm Hg based on measurements at 8 a.m., 10 a.m., and 4 p.m. Mean IOP reductions at the three measurement times ranged from –6.2 to –7.1 mm Hg after 2 weeks and from –6.2 to –7.4 mm Hg after 12 weeks.

Diurnal IOP reduction ≥25% was investigated as a secondary efficacy measure, and this endpoint was achieved by 57% of patients treated with tafluprost after 2 weeks and in 60% of tafluprost-treated patients after 12 weeks. There were numerical differences favoring tafluprost over timolol for most IOP measurements obtained at the 2-, 6-, and 12-week follow-up visits and for all comparisons of proportions of patients achieving a 25% or greater reduction from baseline diurnal IOP.

Rates of conjunctival hyperemia and of ocular pain/stinging/irritation were both only 4.4% in the tafluprost group. The authors of the study noted that while the rate of hyperemia associated with tafluprost was higher than in the timolol group, the rate of hyperemia in the tafluprost patients was low overall considering rates of 12% to 47% have been reported in studies of latanoprost (Xalatan, Pfizer). Other published studies of tafluprost include a 24-month phase III clinical trial randomly assigning 533 patients to preservative-containing tafluprost or latanoprost 0.005% that established the noninferiority of tafluprost to latanoprost over all diurnal IOP measurements [Acta Ophthalmologica. 2010;88:12-19].