Mercury-3 Exploratory Analyses: Netarsudil/Latanoprost Efficacy And Tolerability Stratified By Prior Prostaglandin Use In Patients With Glaucoma And Ocular Hypertension.

Netarsudil (NET) is a Rho kinase inhibitor (ROCKi) developed for the treatment of glaucoma. NET is new to the market in Europe; however, it has been extensively studied as monotherapy, and increasingly studied in combination with latanoprost (NET/LAT) in clinical programmes, real-world studies and practice.

In the MERCURY-1 and -2 studies, and a pooled analysis of these, NET/LAT demonstrated a reduction in mean diurnal IOP of 7.6–8.1 mmHg from baseline (mean 23.5–23.7 mmHg) over 3 months. The recent MERCURY-3 study reported a mean diurnal IOP with NET/LAT of 15.4–15.6 mmHg over 3 months.

In routine practice, NET/LAT may be used in people both with or without prior prostaglandin (PGA) treatment (in monotherapy or in combination therapy).

MERCURY-3 was a Phase 3 head-to-head six-month prospective, double-masked, randomized, parallel-group, non-inferiority study that compared NET/LAT 0.02%/0.005% (Roclanda®) with bimatoprost 0.03%/timolol maleate 0.5% (BIM/TIM; Ganfort®) [submitted].

Exploratory analyses of the MERCURY-3 trial dataset assessed intraocular pressure (IOP)-lowering efficacy and reported treatment-related conjunctival hyperaemia (CH) with NET/LAT and BIM/TIM stratified by prior PGA exposure.

Following washout, patients were randomized to once-daily NET/LAT or BIM/TIM for up to 3 months in the efficacy analyses. This analysis of NET/LAT and BIM/TIM efficacy in those with and without prior PGA treatment was performed in the intention-to-treat (ITT) population.

Data are presented as mean IOP reduction at Week 2, Week 6 and Month 3; IOP was measured at 08:00, 10:00 and 16:00 at each visit. Biomicroscopic grading of conjunctival hyperemia (CH) was performed on a standardised, 4-point scale: 0 = none (normal); 1=mild; 2=moderate; 3=severe at all visits. This analysis was performed in the study safety population.

In the NET/LAT ITT set, 171/218 had received PGA treatment as monotherapy or in combination. Mean IOP (mmHg) at treatment Day 1 was 25.1, then 15.3, 15.7 and 15.6 at Wk 2, Wk 6 and Month 3 respectively with prior PGA therapy. With no prior PGA therapy, mean IOP at Day 1was 24.8; IOP reduced to 15.9 at Wk 2, 15.5 at Wk 6 and 15.7 at Month 3.

Results were similar in the BIM/TIM group, and, in both treatment arms, change in IOP was similar with prior PGA as monotherapy or in combination.

In those reporting CH (72/218 with NET/LAT; 11/212 with BIM/TIM), proportions by PGA use were similar: for NET/LAT, 78% with CH had prior PGA therapy (22% had no prior PGA use), and for BIM/TIM 74% with CH had prior PGA therapy (26% had no prior PGA use).

The exploratory analysis of MERCURY-3 demonstrated that the IOP-reducing efficacy of NET/LAT was consistent whether a patient had received prior PGA (either as monotherapy or in combination) or not. The corresponding hyperaemia frequency figures for patients with/without prior PGA therapy were similar in the NET/LAT and BIM/TIM arms.

These findings can help physicians to make informed decisions on treatment initiation for optimized management of glaucoma and ocular hypertension.