June 2017
Volume 58, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2017
A double-masked, randomized, parallel study of Netarsudil Ophthalmic Solution, 0.02% QD compared to timolol maleate ophthalmic solution, 0.5% BID in patients with elevated intraocular pressure (ROCKET-4)
Author Affiliations & Notes
  • Albert S Khouri
    Ophthalmology, Rutgers - New Jersey Med Sch, Newark, New Jersey, United States
  • Theresa Heah
    Aerie Pharmaceuticals, Inc, Bedmnister, New Jersey, United States
  • Casey Kopczynski
    PharmaLogic Development, Inc, San Rafael, California, United States
  • Gary D Novack
    PharmaLogic Development, Inc, San Rafael, California, United States
    Departments of Ophthalmology and Pharmacology, University of California, Davis, California, United States
  • Footnotes
    Commercial Relationships   Albert Khouri, Aerie Pharmaceuticals, Inc (F), Alcon (S), Allergan (F), Allergan (S), Glaukos (S), NJ Health Foundation (F); Theresa Heah, Aerie Pharmaceuticals, Inc (E), Aerie Pharmaceuticals, Inc. (I); Casey Kopczynski, Aerie Pharmaceuticals, Inc (E), Aerie Pharmaceuticals, Inc. (I); Gary Novack, Aerie Pharmaceuticals, Inc (C)
  • Footnotes
    Support  Aerie Pharmaceuticals, Inc
Investigative Ophthalmology & Visual Science June 2017, Vol.58, 2461. doi:
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      Albert S Khouri, Theresa Heah, Casey Kopczynski, Gary D Novack; A double-masked, randomized, parallel study of Netarsudil Ophthalmic Solution, 0.02% QD compared to timolol maleate ophthalmic solution, 0.5% BID in patients with elevated intraocular pressure (ROCKET-4). Invest. Ophthalmol. Vis. Sci. 2017;58(8):2461.

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

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Abstract

Purpose : Netarsudil is a Rho kinase and norepinephrine transporter inhibitor that appears to lower intraocular pressure (IOP) by enhancing trabecular outflow and reducing episcleral venous pressure (Kiel and Kopczynski, 2015; Wang et al, 2015). In controlled trials, once-daily netarsudil 0.02% has demonstrated effectiveness at lowering IOP in patients with open angle glaucoma (OAG) or ocular hypertension (OHT) (Bacharach et al, 2015; Lewis et al, 2016; Katz et al, 2016). The objective of this study was to further evaluate the efficacy and safety of netarsudil relative to timolol.

Methods : This was a double-masked, randomized, parallel-group trial in subjects with OAG or OHT treated with netarsudil 0.02% QD or timolol 0.5% BID. Subjects had unmedicated IOP >20 mmHg and < 30 mmHg at 08:00 hr, and > 17 mmHg and < 30 mmHg at 10:00 and 16:00 hrs. Subjects with contraindications to timolol were excluded. The primary efficacy endpoint was non-inferiority to timolol in the per-protocol population with baseline IOP < 25 mm Hg. Reported here is a planned 3-month interim analysis.

Results : Enrolled were 708 subjects, of which 423 were in the primary efficacy population. Completing 3 months were 88% (189/214) and 95% (199/209) of subjects in the netarsudil and timolol groups, respectively. Mean IOP at baseline visits was similar among the treatment groups, ranging from 20.7 to 22.4 mmHg. Over the 3-month treatment period, netarsudil demonstrated non-inferiority to timolol across all time points, with mean IOP ranging from 16.3 to 17.8 mmHg for netarsudil and 16.7 to 17.6 for timolol. In a pre-specified analysis, netarsudil also demonstrated non-inferiority in subjects with baseline IOP < 28 mmHg. The most frequent adverse event was conjunctival hyperemia, which was reported in 148 subjects (42.2%) in the netarsudil group and 24 (6.7%) in the timolol group. When present, conjunctival hyperemia was predominately of mild (117/148) or moderate severity (29/148). No drug-related systemic adverse events were reported for netarsudil.

Conclusions : Once-daily netarsudil was non-inferior to twice-daily timolol in patients with baseline IOP < 25 mm Hg (primary) and patients with baseline IOP < 28 mmHg (secondary). Mild conjunctival hyperemia was the most frequent adverse event.

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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