One Year of Netarsudil and Latanoprost Fixed-Dose Combination for Elevated Intraocular Pressure : Phase 3, Randomized MERCURY-1 Study

Copyright © 2020 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved..

PURPOSE: A phase 3 trial (MERCURY-1) investigated efficacy and safety of a once-daily, fixed-dose combination (FDC) of netarsudil and latanoprost, compared with each active component, in reducing elevated intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). A planned 3-month analysis demonstrated the superiority of netarsudil/latanoprost FDC over its individual active components at every assessment. Herein, the 12-month efficacy and safety of netarsudil/latanoprost FDC are reported.

DESIGN: Double-masked, randomized, active-controlled, parallel-group trial.

PARTICIPANTS: Patients had unmedicated IOP >20 to <36 mmHg in both eyes at 8:00 am and met other standard criteria for OAG or OHT.

METHODS: Randomization to once-daily netarsudil 0.02%/latanoprost 0.005% FDC (n = 238), netarsudil 0.02% only (n = 243), or latanoprost 0.005% only (n = 237). Patients instilled study drug into each eye between 8:00 pm and 10:00 pm.

MAIN OUTCOME MEASURES: IOP was obtained at 8:00 am, 10:00 am, and 4:00 pm on day 1 (baseline); at weeks 2 and 6; and at months 3, 6, 9, and 12. Ocular and systemic safety were evaluated up to month 12.

RESULTS: Netarsudil/latanoprost FDC maintained statistically superior IOP lowering compared to its components at every assessment for 12 months. Least squares mean diurnal IOP (± standard error) at month 12 was 16.2 ± 0.23 mmHg for netarsudil/latanoprost FDC, 17.9 ± 0.20 mmHg for netarsudil, and 17.6 ± 0.18 mmHg for latanoprost (P < 0.05 for netarsudil/latanoprost FDC versus each comparator). The safety profile of netarsudil/latanoprost FDC was consistent with its individual components. The proportion of patients who experienced at least 1 adverse event (AE) was 82.8% (197/238) in the netarsudil/latanoprost FDC group, 78.2% (190/243) in the netarsudil group, and 54.0% (128/237) in the latanoprost group. The most common AE was conjunctival hyperemia, mostly of mild severity, with an incidence of 63.0% in the netarsudil/latanoprost FDC treatment group compared with 51.4% in the netarsudil group and 21.9% in the latanoprost group.

CONCLUSIONS: Results at 12 months revealed superior efficacy for netarsudil/latanoprost FDC compared with the individual components, netarsudil and latanoprost, at every time point assessed and an ocular tolerability profile similar to that of netarsudil alone.

Medienart:

E-Artikel

Erscheinungsjahr:

2020

Erschienen:

2020

Enthalten in:

Zur Gesamtaufnahme - volume:3

Enthalten in:

Ophthalmology. Glaucoma - 3(2020), 5 vom: 22. Sept., Seite 327-338

Sprache:

Englisch

Beteiligte Personen:

Brubaker, Jacob W [VerfasserIn]
Teymoorian, Savak [VerfasserIn]
Lewis, Richard A [VerfasserIn]
Usner, Dale [VerfasserIn]
McKee, Hayley J [VerfasserIn]
Ramirez, Nancy [VerfasserIn]
Kopczynski, Casey C [VerfasserIn]
Heah, Theresa [VerfasserIn]

Links:

Volltext

Themen:

11P2JDE17B
6Z5B6HVF6O
Benzoates
Beta-Alanine
Clinical Trial, Phase III
Journal Article
Latanoprost
Multicenter Study
Netarsudil
Ophthalmic Solutions
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
W6I5QDT7QI

Anmerkungen:

Date Completed 14.09.2021

Date Revised 14.09.2021

published: Print-Electronic

Citation Status MEDLINE

doi:

10.1016/j.ogla.2020.05.008

funding:

Förderinstitution / Projekttitel:

PPN (Katalog-ID):

NLM313434018