One Year of Netarsudil and Latanoprost Fixed-Dose Combination for Elevated Intraocular Pressure: Phase 3, Randomized MERCURY-1 Study.
Ophthalmol Glaucoma
; 3(5): 327-338, 2020.
Article
em En
| MEDLINE
| ID: mdl-32768361
ABSTRACT
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 800 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 800 pm and 1000 pm. MAIN OUTCOMEMEASURES:
IOP was obtained at 800 am, 1000 am, and 400 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.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Benzoatos
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Hipertensão Ocular
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Beta-Alanina
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Latanoprosta
/
Pressão Intraocular
Tipo de estudo:
Observational_studies
/
Prognostic_studies
/
Risk_factors_studies
Limite:
Adolescent
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Adult
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Aged
/
Aged80
/
Female
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Humans
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Male
/
Middle aged
Idioma:
En
Ano de publicação:
2020
Tipo de documento:
Article