ARVO 2011: PH&T Latanoprost eye drops showed full therapeutical equivalence against Xalatan.

May 2011 A large Multicenter randomized trial involving 185 glaucoma patients, presented at the ARVO meeting, has shown that PH&T Latanoprost eye drops showed full therapeutical equivalence in terms of efficacy and safety against innovator Xalatan.

PRIMARY EFFICACY RESULTS: At baseline, mean IOP levels were similar across groups at each time point and for diurnal measurement. With regard to the primary efficacy variable, mean IOP level (9:00 AM, 1:00 PM and 5:00 PM) at baseline was 22.8 mm Hg in both treatment groups. By week 12 a significant (P<.001) reduction was observed in both treatment groups (16.4 mm Hg in both groups). Results of per protocol analyses of changes from baseline to week 12 in mean IOP levels (at the three times) were as follows: LS mean (95% confidence inter­val) was -6.41 mm Hg (-6.82 - -5.99) for Galaxia treated patients and -6.40 mm Hg (-6.80 - -6.00) for the Xalatan®-treated patients. Treatment differ­ence was 0.00 mm Hg and 95 % confidence interval -0.58 - + 0.57.

SECONDARY EFFICACY RESULTS: The mean change from baseline in IOP measured at 9.00 was significant from 2-week treatment on in both groups, with a relevant reduction from base­line to 2 weeks, followed by a slow decrease until end of study. The estimation of the ANCOVA model was based on all 184 patients included in the ITT population. The LS means of percent change in IOP from baseline to end of treatment were -27.2% (95% CI: -29, -25.4) in the Latanoprost PK group and -27.9% (-29.7, -26.1) in the Xalatan® group. The estimate of the difference between treatments (Latanoprost PK - Xalatan®) was 0.67% (95% CI: -1.90, 3.24, p-value = 0.608).