A randomised, controlled comparison of latanoprostene bunod and latanoprost 0.005% in the treatment of ocular hypertension and open angle glaucoma: the VOYAGER study

Robert N Weinreb, Tuyen Ong, Baldo Scassellati Sforzolini, Jason L Vittitow, Kuldev Singh, Paul L Kaufman, VOYAGER study group, Robert N Weinreb, Tuyen Ong, Baldo Scassellati Sforzolini, Jason L Vittitow, Kuldev Singh, Paul L Kaufman, VOYAGER study group

Abstract

Aim: To assess the efficacy and safety of latanoprostene bunod (LBN) compared with latanoprost 0.005%, and to determine the optimum drug concentration(s) of LBN in reducing intraocular pressure (IOP) in subjects with open angle glaucoma or ocular hypertension.

Methods: Randomised, investigator-masked, parallel-group, dose-ranging study. Subjects instilled one drop of study medication in the study eye once daily each evening for 28 days and completed five study visits. The primary efficacy endpoint was the reduction in mean diurnal IOP at Day 28.

Results: Of the 413 subjects randomised (LBN 0.006%, n=82; LBN 0.012%, n=85; LBN 0.024%, n=83; LBN 0.040%, n=81; latanoprost, n=82), 396 subjects completed the study. Efficacy for LBN was dose-dependent reaching a plateau at 0.024%-0.040%. LBN 0.024% led to significantly greater reductions in diurnal IOP compared with latanoprost at the primary endpoint, Day 28 (p=0.005), as well as Days 7 (p=0.033) and 14 (p=0.015). The incidence of adverse events, mostly mild and transient, was numerically higher in the LBN treatment groups compared with the latanoprost group. Hyperaemia was similar across treatments.

Conclusions: LBN 0.024% dosed once daily was the lower of the two most effective concentrations evaluated, with significantly greater IOP lowering and comparable side effects relative to latanoprost 0.005%. LBN dosed once daily for 28 days was well tolerated.

Clinical trial number: NCT01223378.

Keywords: Clinical Trial; Drugs; Glaucoma; Intraocular pressure; Treatment Medical.

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Figures

Figure 1
Figure 1
Mean diurnal intraocular pressure (IOP) in the study eye at baseline and on Day 28 (intent-to-treat population). *p=0.005 versus latanoprost; †p=0.009 versus latanoprost. LBN, latanoprostene bunod.
Figure 2
Figure 2
Proportion of subjects with intraocular pressure (IOP) ≤18 mm Hg at follow-up visits (intent-to-treat population). *p<0.05 versus latanoprost. LBN, latanoprostene bunod.

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