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, Heah T, Ramirez-Davis N, Usner DW, Novack GD, Kopczynski CC.
Main finding: Netarsudil 0.02% was found to be non-inferior to timolol for the treatment of some patients with ocular hypertension and open-angle glaucoma.
Purpose: To compare the efficacy and safety of the Rho kinase inhibitor netarsudil and timolol in Ocular Hypertension/Open-angle glaucoma
Study type: Randomized controlled trial
Condition: Open angle glaucoma, Ocular Hypertension
Participants: ≥18yo with bilateral OHT or OAG, IOP 21-26 at 1st visit and 18-26 at 2nd visit in at least 1 eye
n=1167 (ROCKET-1 and 2 combined)
Intervention:
Group 1: Netarsudil 0.02% daily
Group 2: Netarsudil 0.02% bd
Group 3: Timolol 0.5% bd
Netarsudil (od and bd dosing) was non-inferior to timolol in patients with maximum baseline IOP < 25 mm Hg
Outcomes
Netarsudil daily
Netarsudil bd
Timolol bd
Mean decrease from baseline IOP (mmHg)
3.3-4.6
4.1-5.4
3.7-5.1
Reduction in IOP
16-21%
22-24%
18-23%
August 1, 2019
Clinical trial
Once-Daily Netarsudil Versus Twice-Daily Timolol in Patients With Elevated Intraocular Pressure: The Randomized Phase 3 ROCKET-4 Study.
Khouri AS, Serle JB, Bacharach J, Usner DW, Lewis RA, Braswell P, Kopczynski CC, Heah T.
Main finding: Netarsudil 0.02% was found to be non-inferior to timolol for the treatment of some patients with ocular hypertension and open-angle glaucoma.
Purpose: To compare the efficacy and safety of the Rho kinase inhibitor netarsudil and timolol in Ocular Hypertension/Open-angle glaucoma
Study type: Randomized controlled trial
Condition: Open angle glaucoma, Ocular Hypertension
Participants: ≥18yo with bilateral OHT or OAG, IOP 21-26 at 1st visit and 18-26 at 2nd visit in at least 1 eye
n=1167 (ROCKET-1 and 2 combined)
Intervention:
Group 1: Netarsudil 0.02% daily
Group 2: Netarsudil 0.02% bd
Group 3: Timolol 0.5% bd
Follow up = 3 months
Netarsudil was noninferior to timolol in patients with baseline IOP <27 mm Hg and <30 mm Hg.
IOP lowering effect was sustained at 6 months.
The most common adverse effect was conjunctival hyperaemia (47.9%), mostly mild.
Outcomes
Netarsudil bd
Timolol bd
Mean decrease from baseline IOP (mmHg)
3.9-4.7
3.8-5.2
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