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Netarsudil Improves Trabecular Outflow Facility in Patients with Primary Open Angle Glaucoma or Ocular Hypertension: A Phase 2 Study.

Publication ,  Journal Article
Sit, AJ; Gupta, D; Kazemi, A; McKee, H; Challa, P; Liu, KC; Lopez, J; Kopczynski, C; Heah, T
Published in: Am J Ophthalmol
June 2021

PURPOSE: Intraocular pressure (IOP) reduction is key to controlling primary open angle glaucoma (POAG). Pharmacotherapies for POAG or ocular hypertension (OHT) commonly lower IOP by increasing uveoscleral outflow or decreasing aqueous humor production. Netarsudil (Rhopressa), a Rho kinase inhibitor, reduces IOP by improving trabecular outflow facility, which is reduced in POAG. We investigated the effects of netarsudil on aqueous humor dynamics in patients with POAG or OHT. DESIGN: Double-masked, randomized, vehicle-controlled, Phase 2 trial. METHODS: Netarsudil 0.02% was instilled in 1 eye and vehicle into the contralateral eye of 20 patients once daily in the morning for 7 days. The primary endpoint was change in mean diurnal outflow facility on day 8 versus that on day 1 (baseline). Outflow facility was measured by using Schiøtz tonography, IOP by pneumotonometry, and episcleral venous pressure (EVP) by automated venomanometry. RESULTS: Eighteen patients (90%) completed the study. Mean diurnal outflow facility increased 0.039 versus 0.007 µL/min/mm Hg from baseline in the netarsudil- and the vehicle-treated groups, respectively (P < .001 vs. baseline for netarsudil), a treatment difference of 0.03 µL/min/mm Hg (P ≤ .001). Mean diurnal IOP change from baseline at day 8 was -4.52 mm Hg for netarsudil versus -0.98 mm Hg for vehicle, a treatment difference of -3.54 mm Hg (P < .0001). Mean diurnal EVP change from baseline was -0.79 mm Hg in the netarsudil-treated group versus 0.10 mm Hg for vehicle, a treatment difference of -0.89 mm Hg (P < .001). All patients reporting an adverse event reported conjunctival hyperemia of mild or moderate severity. CONCLUSIONS: Netarsudil acts on the conventional outflow pathway, both proximal and distal, to significantly reduce IOP in POAG and OHT by improving trabecular outflow facility and decreasing EVP.

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Published In

Am J Ophthalmol

DOI

EISSN

1879-1891

Publication Date

June 2021

Volume

226

Start / End Page

262 / 269

Location

United States

Related Subject Headings

  • rho-Associated Kinases
  • beta-Alanine
  • Trabecular Meshwork
  • Tonometry, Ocular
  • Protein Kinase Inhibitors
  • Ophthalmology & Optometry
  • Ophthalmic Solutions
  • Ocular Hypertension
  • Middle Aged
  • Male
 

Citation

APA
Chicago
ICMJE
MLA
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Sit, A. J., Gupta, D., Kazemi, A., McKee, H., Challa, P., Liu, K. C., … Heah, T. (2021). Netarsudil Improves Trabecular Outflow Facility in Patients with Primary Open Angle Glaucoma or Ocular Hypertension: A Phase 2 Study. Am J Ophthalmol, 226, 262–269. https://doi.org/10.1016/j.ajo.2021.01.019
Sit, Arthur J., Divakar Gupta, Arash Kazemi, Hayley McKee, Pratap Challa, Katy C. Liu, Jae Lopez, Casey Kopczynski, and Theresa Heah. “Netarsudil Improves Trabecular Outflow Facility in Patients with Primary Open Angle Glaucoma or Ocular Hypertension: A Phase 2 Study.Am J Ophthalmol 226 (June 2021): 262–69. https://doi.org/10.1016/j.ajo.2021.01.019.
Sit AJ, Gupta D, Kazemi A, McKee H, Challa P, Liu KC, et al. Netarsudil Improves Trabecular Outflow Facility in Patients with Primary Open Angle Glaucoma or Ocular Hypertension: A Phase 2 Study. Am J Ophthalmol. 2021 Jun;226:262–9.
Sit, Arthur J., et al. “Netarsudil Improves Trabecular Outflow Facility in Patients with Primary Open Angle Glaucoma or Ocular Hypertension: A Phase 2 Study.Am J Ophthalmol, vol. 226, June 2021, pp. 262–69. Pubmed, doi:10.1016/j.ajo.2021.01.019.
Sit AJ, Gupta D, Kazemi A, McKee H, Challa P, Liu KC, Lopez J, Kopczynski C, Heah T. Netarsudil Improves Trabecular Outflow Facility in Patients with Primary Open Angle Glaucoma or Ocular Hypertension: A Phase 2 Study. Am J Ophthalmol. 2021 Jun;226:262–269.
Journal cover image

Published In

Am J Ophthalmol

DOI

EISSN

1879-1891

Publication Date

June 2021

Volume

226

Start / End Page

262 / 269

Location

United States

Related Subject Headings

  • rho-Associated Kinases
  • beta-Alanine
  • Trabecular Meshwork
  • Tonometry, Ocular
  • Protein Kinase Inhibitors
  • Ophthalmology & Optometry
  • Ophthalmic Solutions
  • Ocular Hypertension
  • Middle Aged
  • Male