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  • Glaucoma

    This study compared the efficacy of a fixed-dose netarsudil/latanoprost combination therapy versus individual monotherapies for open-angle glaucoma and ocular hypertension.

    Study design

    This randomized, double-masked, phase 3 clinical trial included 718 patients. Patients with an untreated IOP of 20 to 36 mm Hg were randomized to once-daily netarsudil/latanoprost, netarsudil 0.02% or latanoprost 0.005% for up to 12 months. Diurnal IOP was measured at week 2 and 6 and month 3.

    Outcomes

    The combination therapy resulted in superior IOP reduction at all time points, lowering IOP by an additional 1.3 to 3 mm Hg compared with both monotherapies. At month 3, 43.5% of combination therapy arm had an IOP of 15 mm Hg or less. There were no treatment-related serious adverse events. Conjunctival hyperemia was the most frequent ocular adverse event.

    Limitations

    This study was supported by Aerie Pharmaceuticals, manufacturers of both netarsudil and the fixed-dose combination netarsudil/latanoprost. At 3 months, there was a higher discontinuation rate in the netarsudil-containing intervention groups (14%–17%) than in the latanoprost group (none) due to adverse events.

    Clinical significance

    The fixed-dose combination of netardusil/latanoprost offers patients a once-a-day dosing option that provides superior IOP reduction than other once-a-day treatments. Patients should be warned that conjunctival hyperemia is common, but is usually mild. Other ocular adverse events included intermittent conjunctival hemorrhage and corneal verticillata.