Pooled Efficacy and Safety Profile of Netarsudil Ophthalmic Solution 0.02% in Patients with Open-angle Glaucoma or Ocular Hypertension.

PRECIS In pooled Phase III analyses, once-daily netarsudil 0.02% resulted in intraocular pressure reduction that was non-inferior to twice-daily timolol 0.5%, with minimal treatment-related serious or systemic adverse events. Ocular adverse events were generally tolerable. PURPOSE To assess the efficacy and safety of the Rho kinase inhibitor netarsudil in patients with open-angle glaucoma or ocular hypertension. PATIENTS AND METHODS Pooled analysis of data from the ROCKET-1 to 4 Phase III studies of once-daily (PM) netarsudil or twice-daily timolol in patients with open-angle glaucoma or ocular hypertension. The primary efficacy measure was mean intraocular pressure (IOP) at 8:00 AM, 10:00 AM, and 4:00 PM at Week 2, Week 6, and Month 3 in patients with baseline IOP <25▒mmHg. RESULTS In the pooled primary efficacy population (netarsudil, n=494; timolol, n=510), once-daily netarsudil was noninferior to twice-daily timolol at all nine time points through Month 3. Mean treated IOP ranged from 16.4-18.1▒mmHg among netarsudil-treated patients and 16.8-17.6▒mmHg among timolol-treated patients. In the pooled safety population (n=839 in each treatment group), treatment-related serious adverse events occurred at similar frequencies in each treatment group (netarsudil, 0.1%; timolol, 0%). The most common ocular adverse event, conjunctival hyperemia (netarsudil, 54.4%; timolol, 10.4%), was graded as mild in 77.6% (354/456) of affected netarsudil-treated patients. CONCLUSIONS Once-daily netarsudil resulted in IOP lowering that was non-inferior to twice-daily timolol, with tolerable ocular adverse events that were generally mild and self-resolving. As a first-in-class agent in the United States, with a novel mechanism of action, netarsudil may provide a useful therapeutic option for patients who would benefit from IOP lowering.