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Once-daily netarsudil noninferior to twice-daily timolol in phase 3 study
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Once-daily netarsudil was noninferior to twice-daily timolol for IOP-lowering efficacy in patients with open-angle glaucoma or ocular hypertension, according to the phase 3 ROCKET-4 study.
“In ROCKET-4, a large multicenter trial that was published in the American Journal of Ophthalmology this year, netarsudil once daily was noninferior to timolol used twice day. This effect persisted at various baseline IOPs for the duration of the study. There were no systemic side effects for netarsudil, unlike timolol, which led to the expected reduction in heart rate,” lead study author Albert S. Khouri, MD, told Healio.com/OSN.
One hundred eighty-six patients with an unmedicated baseline IOP between 20 mm Hg and 30 mm Hg at 8 a.m. were included in the double-masked, randomized, noninferiority study. Patients with open-angle glaucoma or ocular hypertension were randomly assigned to receive once-daily Rhopressa (netarsudil ophthalmic solution 0.02%, Aerie Pharmaceuticals) or twice-daily timolol ophthalmic solution 0.5%. The primary endpoint of the study was mean IOP at 8 a.m., 10 a.m. and 4 p.m. at week 2, week 6 and month 3 in patients with baseline IOP less than 25 mm Hg.
Mean IOP ranged from 16.3 mm Hg to 17.9 mm Hg for netarsudil patients and from 16.7 mm Hg to 17.6 mm Hg for timolol patients between 2 weeks and 3 months. Mean IOP reductions from baseline were 3.9 mm Hg to 4.7 mm Hg for netarsudil patients and 3.8 mm Hg to 5.2 mm Hg for timolol patients. The reductions in IOP from baseline were statistically significant (both P < .0001).
The upper bounds of the 95% confidence interval for the IOP differences between the two cohorts were within 1.5 mm Hg at all time points from week 2 to month 3 and within 1 mm Hg at most time points, indicating netarsudil was noninferior to timolol, according to the study.
“Netarsudil also has other effects including the reduction of episcleral venous pressure, which is very important in reducing the downstream pressure and likely further aids in the IOP reduction at lower levels of IOP,” Khouri said. – by Robert Linnehan
Disclosures: Khouri reports he receives research grant support from Allergan, Aerie Pharmaceuticals and the New Jersey Health Foundation; is on the speakers bureaus for Novartis, Allergan and Glaukos; and is a consultant to Topcon Medical Systems. Please see the study for all other authors’ relevant financial disclosures.
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