Reduction of elevated intraocular pressure (IOP) caused by open-angle glaucoma or ocular hypertension.
Rho kinase and norepinephrine transport inhibitor. Lowers IOP by increasing trabecular outflow.
Instill 1 drop (0.02% ophthalmic solution) in affected eye(s) once daily in evening.
Approval was based on two phase 3 clinical trials (Rocket 1 and Rocket 2) that enrolled 1,167 patients. Patients were randomized to receive netarsudil once daily (Rocket 1 or Rocket 2) or BID (Rocket 2 only). Timolol was dosed BID in both studies. Treatment with netarsudil once daily produced clinically and statistically significant reductions of IOP from baseline (P<0.001) and was noninferior to timolol in the per-protocol population, with maximum baseline IOP <25 mm Hg in both studies.
Medscape © 2018 WebMD, LLC
Any views expressed above are the author's own and do not necessarily reflect the views of WebMD or Medscape.
Cite this: Mary L Windle. FDA New Drug and Biologic Approvals -- 2017 Year-in-Review - Medscape - Jan 11, 2018.