Effects of Switching to Netarsudil/Latanoprost Fixed Dose Combination from Various Latanoprost Regimens: The Phase 4 MORE Study.

Abstract

Purpose: To determine the effect on intraocular pressure (IOP) of switching to a once-daily netarsudil/latanoprost fixed dose combination (FDC) from various topical treatment regimens including latanoprost monotherapy or latanoprost combined with other IOP-lowering agents for the treatment of open-angle glaucoma or ocular hypertension.

Methods: A total of 136 participants enrolled. Eligible participants were aged ≥18 years and had a current diagnosis of open-angle glaucoma or ocular hypertension. Additional inclusion criteria were current treatment regimens with latanoprost monotherapy, latanoprost plus 1 additional IOP-lowering agent, or latanoprost plus 2 agents; current IOP-lowering regimen stable for ≥30 days prior to baseline visit; treated morning IOP ≥20 mmHg at baseline visit; and best corrected visual acuity (BCVA) of 20/100 or better in both eyes. Regardless of their initial regimens, all participants stopped their IOP-lowering medication(s) and were switched directly to netarsudil/latanoprost FDC alone.

Results: Participants experienced substantial reductions in IOP. At week 12, the mean percent change from baseline in IOP was -18.5% (SD 18.96) in the overall study population and was similar in the latanoprost monotherapy group (-21.2% [SD 17.46]), the latanoprost +1 agent group (-15.7% [SD 21.91]), and the latanoprost +2 agents group (-16.9% [SD 17.31]). Less than one-third of participants (31.6%) experienced any ocular adverse event or an ocular adverse event related to treatment (27.2%). The most common ocular adverse event was conjunctival hyperemia (18.4%). Most ocular adverse events were mild, and two severe ocular adverse events of hyperemia (1.5%) were reported; no serious ocular adverse events were reported.

Conclusion: In this study, additional IOP lowering was achievable when patients switched to netarsudil/latanoprost FDC after treatment with latanoprost alone or latanoprost with 1 or 2 additional agents. The once-daily administration of netarsudil/latanoprost FDC and reduced treatment burden for those on latanoprost combined with additional agents may prove more manageable for patients.