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Clinical Trial
. 2025 Jan 21:19:175-186.
doi: 10.2147/OPTH.S491636. eCollection 2025.

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

Jason Bacharach  1 , Ehsan Sadri  2 , Gagan Sawhney  3 , Casey Kopczynski  4 , Mohinder M Merchea  4
Affiliations
Clinical Trial

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

Jason Bacharach et al. Clin Ophthalmol. .

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.

Keywords: glaucoma; intraocular pressure; prostaglandin analog; rho-kinase inhibitor.

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Conflict of interest statement

Drs. Bacharach and Sawhney report receiving honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Alcon. Dr Bacharach also reports research grant from Aerie. Drs. Kopczynski and Merchea report being employed by Alcon. Dr. Sadri reports receiving grant funding from Alcon. Dr. Kopczynski reported receiving travel and material support from Alcon and owning stock in Alcon. Dr Kopczynski reports patents US11707460B2, US11185538B2, US11197853B2, US10588901B2, US9993470B2, US9931336B2, and US9415043B2 issued to Alcon. Dr. Sadri reported having a leadership or fiduciary role at Visionary Ventures. The authors report no other conflicts of interest in this work.

Figures

Figure 1
Figure 1
Participant disposition. Study population: mITT population.
Figure 2
Figure 2
Mean percent change in IOP from baseline to week 12 in (A) the full study population and (B) the latanoprost + 1 subgroups. Study population: mITT population.
Figure 3
Figure 3
Mean absolute change in IOP from baseline to week 12 in (A) the full study population and (B) the latanoprost + 1 subgroups. Study population: mITT population.
Figure 4
Figure 4
Proportion of participants at or below IOP thresholds at week 12. Study population: mITT population.
Figure 5
Figure 5
Proportion of participants at or below IOP percent reduction thresholds at week 12. Study population: mITTpopulation.
See this image and copyright information in PMC

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