June 2017
Volume 58, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2017
Ocular Hypotensive Efficacy of Netarsudil Ophthalmic Solution 0.02% Over a 24-Hour Period: A Pilot Study
Author Affiliations & Notes
  • James H Peace
    United Medical Research Institution, Inglewood, California, United States
  • Casey Kopczynski
    Research and Development, Aerie Pharmaceuticals, Durham, North Carolina, United States
  • Theresa G H Heah
    Clinical Research and Medical Affairs, Aerie Pharmaceuticals, Bedminster, New Jersey, United States
  • Footnotes
    Commercial Relationships   James Peace, Aerie Pharmaceuticals (C), Alcon (C), Allergan (C); Casey Kopczynski, Aerie Pharmaceuticals (E); Theresa Heah, Aerie Pharmaceuticals (E)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science June 2017, Vol.58, 2460. doi:
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      James H Peace, Casey Kopczynski, Theresa G H Heah; Ocular Hypotensive Efficacy of Netarsudil Ophthalmic Solution 0.02% Over a 24-Hour Period: A Pilot Study. Invest. Ophthalmol. Vis. Sci. 2017;58(8):2460.

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

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Abstract

Purpose : Netarsudil (previously known as AR-13324) is a Rho kinase and norepinephrine transporter inhibitor that appears to lower intraocular pressure (IOP) by increasing outflow through the trabecular meshwork and decreasing episcleral venous pressure. The ocular hypotensive efficacy of netarsudil in subjects with ocular hypertension (OHT) or open-angle glaucoma (OAG) has been demonstrated in multiple studies in which IOP was measured during the diurnal period. Based upon its novel pharmacology, we sought to evaluate its efficacy in nocturnal period relative to the diurnal period.

Methods : This was a pilot, double-masked, randomized, single-center, placebo-controlled study comparing netarsudil ophthalmic solution to its vehicle, dosed once daily in the evening (20:00-22:00). Eligible were subjects with OHT or OAG with unmedicated IOP between 17 and 30 mmHg. After qualification, patients were randomized 2:1 to netarsudil or vehicle and baseline habitual IOP was measured over a 24-hour period. Patients then self-administered the medication for 7 days and returned on day 8 for another 24-hour IOP measurement. The study was planned for 12 patients, and had power to detect a 2.5 mmHg treatment difference.

Results : All 12 patients enrolled completed the study. The study population was established patients, all previously on ocular hypotensive therapy, and was 50% female, with a mean age of 64.4 ± 8.6 years, 75% black, and 17% Hispanic. Mean baseline IOPs were similar for the netarsudil and vehicle groups and ranged from 21.0 to 24.8 mmHg, with the highest IOPs recorded from midnight to 06:00 hours. After 7 days of dosing, netarsudil achieved statistically significant reductions in mean IOP of 2.6 to 5.0 mmHg across the 8 measured time points (p < 0.01 to < 0.001). Mean diurnal IOP (09:00 to 18:00 hours) and mean nocturnal IOP (21:00 to 06:00 hours) were reduced by 3.5 mmHg and 3.5 mmHg, respectively, for netarsudil compared to 0.4 mmHg and 0.9 mmHg, respectively, for vehicle. There were no safety issues reported.

Conclusions : In patients with OAG or OHT, once-nightly netarsudil ophthalmic solution 0.02% had ocular hypotensive activity throughout 24 hours and was equally effective at lowering IOP in the nocturnal and diurnal periods. There were no safety issues.

This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.

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