The study is a twelve-week multi-center, double-masked, randomized, active-controlled phase III study of 643 patients with open-angle glaucoma or ocular hypertension designed to evaluate the safety and efficacy of preservative-free (PF) tafluprost once-daily and PF timolol twice-daily over a 12-week treatment period.
The study’s primary endpoint was mean IOP change from baseline at nine time points: three times during the day (08:00 hours, 10:00 hours and 16:00 hours) at weeks two, six and 12.
A secondary endpoint of the study was the proportion of patients with =25 percent reduction in diurnal IOP from baseline to week 12.
In 2009, Merck and Santen Pharmaceutical entered into a licensing agreement for tafluprost.
Merck has exclusive commercial rights to tafluprost in Western Europe (excluding Germany), North America, South America, Africa, the Middle East, India and Australia.
Santen retains commercial rights to tafluprost in Germany, most countries in Eastern Europe, northern Europe and in countries in the Asia Pacific region, including Japan.
The new drug application (NDA) for tafluprost is under review by the US Food & Drug Administration for the proposed use in the reduction of elevated IOP in patients with open-angle glaucoma or ocular hypertension.