Two Phase 3 Clinical Trials Comparing the Safety and Efficacy of Netarsudil to Timolol in Patients With Elevated Intraocular Pressure: Rho Kinase Elevated IOP Treatment Trial 1 and 2 (ROCKET-1 and ROCKET-2)
Serle JB, Katz LJ, McLaurin E, et al; ROCKET-1 and ROCKET-2 Study Groups Am J Ophthalmol. 2018;186:116-127
Study Summary
The double-masked ROCKET-1 and ROCKET-2 trials evaluated the efficacy and ocular and systemic safety of netarsudil 0.02% ophthalmic solution, a newly available rho-kinase inhibitor and norepinephrine transporter inhibitor. These large-scale studies enrolling 1167 total patients primarily sought to establish noninferiority of netarsudil to timolol.
Eligible patients with either open-angle glaucoma or ocular hypertension underwent a washout period of all prestudy ocular hypotensive medications, during which their intraocular pressure (IOP) had to be > 17 mm Hg but < 27 mm Hg.
Patients were then randomly assigned to receive netarsudil 0.02% once daily, timolol 0.5% twice a day, or (ROCKET-2 only) netarsudil 0.02% twice daily. Diurnal IOP, as well as side effects including degree of hyperemia, were recorded at day 1, week 2, week 6, and month 3. Each study population had a mean age in the mid-60s, was predominantly female, and approximately 75% white and 25% black.
All three treatment groups produced statistically significant mean reductions from baseline IOP at all nine treatment time points over the 3-month efficacy assessment. Mean IOP ranged from 16.7 mm Hg to 18.2 mm Hg in the netarsudil once-daily group, 15.7 mm Hg to 17.6 mm Hg in the netarsudil twice-daily group, and 16.6 mm Hg to 17.7 mm Hg in the timolol twice-daily group. The mean decreases from baseline IOP ranged from 3.3 mm Hg to 4.6 mm Hg and 4.1 mm Hg to 5.4 mm Hg for the netarsudil once-daily and twice-daily groups, respectively, and from 3.7 mm Hg to 5.1 mm Hg for the timolol twice daily group.
