Posters

Effects of netarsudil on the corneal endothelium: three-month findings from a phase-3 trial in patients with ocular hypertension or open-angle glaucoma

Poster Details

First Author: T.Mundorf USA

Co Author(s):    H. Sheng   T. Heah                 

Abstract Details

Purpose:

Purpose: To describe the changes in corneal endothelial cell density (ECD), the coefficient of variation (CV), and the percent of hexagonal cells (% HEX) following 3 months of therapy with netarsudil ophthalmic solution 0.02% dosed once (q.d.) or twice daily (b.i.d.) and to compare these changes with those seen with timolol 0.5% twice daily in eyes with ocular hypertension or open-angle glaucoma.

Setting:

Setting: 42 clinical sites participating in the Phase 3 ROCKET-2 trial.

Methods:

Methods: A subset of subjects enrolled in a prospective, randomized, double-masked Phase 3 evaluation of the IOP-lowering efficacy and safety of netarsudil 0.02% versus timolol 0.5% underwent corneal endothelial cell imaging by specular microscopy at baseline and following 3 months of therapy. Data from 386 subjects from whom analyzable specular microscopy images were obtained at both baseline and month 3 were included in this analysis. Images were evaluated in masked fashion at an independent reading center. Changes in ECD, CV, and % HEX from baseline to 3 months were compared between treatment groups.

Results:

Results: Mean ECD, CV and % HEX values were comparable between groups at baseline. There were no statistically significant between-group differences in changes from baseline to month 3 in ECD, CV, and %HEX between either of the netarsudil groups and the timolol group. Within groups, CV declined in a statistically significant fashion from baseline to month 3 in all three groups by 1.4-2.1% (p<0.0001), and %HEX increased by a statistically significant amount (0.7%, p=0.0295) in the timolol group. These small changes were unlikely to be of clinical significance. No statistically significant changes in ECD were seen in any group.

Conclusions:

Conclusions: Netarsudil 0.2% dosed once or twice daily for three months in eyes with ocular hypertension or open-angle glaucoma has no clinically significant effects on ECD, CV, or % HEX.

Financial Disclosure:

... is employed by a for-profit company with an interest in the subject of the presentation, ... travel has been funded, fully or partially, by a company producing, developing or supplying the product or procedure presented