July 2019
Volume 60, Issue 9
Free
ARVO Annual Meeting Abstract  |   July 2019
Improvement of trabecular outflow facility by Netarsudil Ophthalmic Solution in patients with primary open angle glaucoma or ocular hypertension
Author Affiliations & Notes
  • Arthur J Sit
    Mayo Clinic, Rochester, Minnesota, United States
  • Divakar Gupta
    Duke University, Durham, North Carolina, United States
  • Arash Kazemi
    Mayo Clinic, Rochester, Minnesota, United States
  • Hayley McKee
    Aerie Pharmaceuticals Inc., Bedminster, New Jersey, United States
  • Jae Lopez
    Aerie Pharmaceuticals Inc., Bedminster, New Jersey, United States
  • Casey Kopczynski
    Aerie Pharmaceuticals Inc., Durham, North Carolina, United States
  • Theresa Heah
    Aerie Pharmaceuticals Inc., Bedminster, New Jersey, United States
  • Footnotes
    Commercial Relationships   Arthur Sit, Aerie Pharmaceuticals, Inc. (F), Aerie Pharmaceuticals, Inc. (C), Allergan, Inc. (C), Injectsense, Inc. (C), Injectsense, Inc. (I), PolyActiva, Pty (C); Divakar Gupta, None; Arash Kazemi, None; Hayley McKee, Aerie Pharmaceuticals, Inc. (E); Jae Lopez, Aerie Pharmaceuticals, Inc. (E), D758048 (P); Casey Kopczynski, Aerie Pharmaceuticals, Inc. (E); Theresa Heah, Aerie Pharmaceuticals, Inc. (E)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science July 2019, Vol.60, 5164. doi:
  • Views
  • Share
  • Tools
    • Alerts
      ×
      This feature is available to authenticated users only.
      Sign In or Create an Account ×
    • Get Citation

      Arthur J Sit, Divakar Gupta, Arash Kazemi, Hayley McKee, Jae Lopez, Casey Kopczynski, Theresa Heah; Improvement of trabecular outflow facility by Netarsudil Ophthalmic Solution in patients with primary open angle glaucoma or ocular hypertension. Invest. Ophthalmol. Vis. Sci. 2019;60(9):5164.

      Download citation file:


      © ARVO (1962-2015); The Authors (2016-present)

      ×
  • Supplements
Abstract

Purpose : To investigate the effect of netarsudil ophthalmic solution 0.02% (AR-13324, a Rho Kinase and norepinephrine transporter inhibitor) on aqueous humor dynamics (AHD) including trabecular outflow facility, episcleral venous pressure (EVP) and intraocular pressure (IOP) in subjects with primary open-angle glaucoma (POAG) or ocular hypertension (OHT).

Methods : In this double-masked, vehicle-controlled, paired-comparison study conducted at 2 centers in the US, subjects (age ≥18 years) with POAG or OHT were randomized to netarsudil 0.02% in the study eye and vehicle in the contralateral eye each morning for 7 days. At baseline, both eyes required post-washout (4 weeks minimum)/treatment-naive IOP of >20 mmHg but <30 mmHg at 08:00. Outflow facility was measured by Schiøtz tonography. IOP was measured by pneumatonometry. EVP was measured using an objective, computer-controlled venomanometer and image analysis software. The primary endpoint was change from baseline in mean diurnal trabecular outflow facility (measurements at 13:00 and 16:00) on Day 8. Comparisons were performed and confidence intervals were calculated using paired t-tests.

Results : Among 20 enrolled subjects (mean age 63 years), 18 were in the modified intent to treat population. Netarsudil increased mean diurnal trabecular outflow facility by 0.04 ± 0.04 µL/min/mmHg (mean ± SD) vs baseline, P=0.0004 (mean 34.6%) and 0.03 µL/min/mmHg vs vehicle-treated contralateral eyes, P=0.0010 (mean 25.0%). Netarsudil reduced mean diurnal IOP by 4.5 ± 1.6 mmHg vs baseline, P<0.0001 (mean -19.6%) and 3.5 mmHg vs vehicle, P<0.0001 (mean -15.3%). Mean diurnal EVP was reduced by 0.8 ± 0.8 mmHg vs baseline, P=0.0113 (mean -9.5%) and 0.9 mmHg vs vehicle, P=0.0003 (mean -12.6%). Adverse Events were reported in the study eyes of 13 subjects (65.0%) and were mild or moderate; none were serious. One subject discontinued due to mild conjunctival hyperemia.

Conclusions : In the patient population studied, once-daily dosing of netarsudil 0.02% lowered IOP in subjects with POAG or OHT by improving outflow facility and reducing EVP. These results suggest netarsudil acts on the conventional outflow pathway including the distal outflow system, a novel mechanism of action among glaucoma medications.

This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.

 

Table: Aqueous Humor Dynamics Parameters in Netarsudil-Treated Eyes (n=18)*

Table: Aqueous Humor Dynamics Parameters in Netarsudil-Treated Eyes (n=18)*

×
×

This PDF is available to Subscribers Only

Sign in or purchase a subscription to access this content. ×

You must be signed into an individual account to use this feature.

×