FDA New Drug and Biologic Approvals -- 2017 Year-in-Review

Mary L Windle, PharmD

Disclosures

January 11, 2018

In This Article

Rhopressa (netarsudil ophthalmic)

Indication:

Reduction of elevated intraocular pressure (IOP) caused by open-angle glaucoma or ocular hypertension.

Mechanism:

Rho kinase and norepinephrine transport inhibitor. Lowers IOP by increasing trabecular outflow.

Dosage:

Instill 1 drop (0.02% ophthalmic solution) in affected eye(s) once daily in evening.

Approval:

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.

Reference:

Serle JB, et al. Two Phase 3 clinical trials comparing the safety and efficacy of netarsudil to timolol in patients with elevated intraocular pressure. Am J Ophthalmol. 2017 Nov 30.

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