Analysis of a fixed-dose combination of netarsudil 0.02% and latanoprost 0.005% in a subset of subjects with ocular hypertension/open-angle glaucoma and history of ocular hypotensive therapy: the pooled MERCURY-1 and -2 phase 3 studies

Session Details

Session Title: Glaucoma Management

Session Date/Time: Monday 16/09/2019 | 16:30-18:00

Paper Time: 16:36

Venue: Free Paper Forum: Podium 4

First Author: : S.Asrani USA

Co Author(s): :    T. Heah                             

Abstract Details

Purpose:

Netarsudil, a novel Rho kinase inhibitor recently approved by the FDA, is believed to reduce intraocular pressure (IOP) by increasing trabecular outflow. Latanoprost is the most frequently prescribed of the prostaglandin analogs, the most effective class of ocular hypotensive agents. A once-daily (QD) fixed-dose combination (FDC) of netarsudil 0.02% and latanoprost 0.005% recently demonstrated significantly reduced IOP vs each active component in subjects with ocular hypertension (OHT) or open-angle glaucoma (OAG). This subgroup analysis of pooled data from the MERCURY studies was performed to investigate whether prior experience with ocular hypotensive therapy affected response to netarsudil/latanoprost FDC.

Setting:

Two phase 3 (MERCURY-1, -2), double-masked, randomized (1:1:1), superiority studies were conducted. MERCURY-1 was conducted in 56 active sites across the United States. MERCURY-2 was conducted in 60 active sites in the United States and Canada.

Methods:

Subjects included in the efficacy analyses of the MERCURY-1 and -2 studies instilled one drop of netarsudil (0.02%)/latanoprost (0.005%) FDC, or netarsudil (0.02%), or latanoprost (0.005%) into each eye QD between 20:00 and 22:00 hours. IOP was measured at 08:00, 10:00, and 16:00 hours at Weeks 2, 6, and Month 3 (primary endpoint). In this pooled analysis, IOP efficacy results in the total intention-to-treat population (N=1468) were compared with results from the large subset of patients with prior therapy with an IOP-lowering medication (n=1024).

Results:

For subjects receiving netarsudil/latanoprost FDC (n=483) baseline mean diurnal IOP was 23.6 mmHg (Day 1). Between Week 2 and Month 3, mean diurnal IOP at each visit was 15.3 (Week 2), 15.7 (Week 6), and 15.8 (Week 12) mmHg. In subjects with a history of ocular hypotensive therapy (n=343), least squares mean diurnal IOP at each visit was 15.2 (Week 2), 15.6 (Week 6), and 15.8 (Week 12) mmHg. The FDC met superiority criteria compared with active components for all nine timepoints in both the total and subgroup populations (all p<0.0001). Pooled safety results were consistent with individual studies.

Conclusions:

In a pooled analysis of two Phase 3 studies, once-daily FDC of netarsudil 0.02%/latanoprost 0.005% produced statistically significant and clinically relevant reductions in mean IOP from baseline in both the total population and in subjects with history of exposure to therapy with an IOP-lowering medication. These results demonstrate that patients in this study with prior glaucoma therapy have similar responses to FDC treatment as the overall population. Results suggest patients with prior glaucoma therapy would benefit from the FDC comprised of a prostaglandin and the novel Rho kinase inhibitor. Pooled analysis for safety results were consistent with the individual studies.

Financial Disclosure:

is employed by a for profit company with an interest in the subject of the presentation, receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented