PMID- 30653957
OWN - NLM
STAT- MEDLINE
DCOM- 20191213
LR  - 20191217
IS  - 1879-1891 (Electronic)
IS  - 0002-9394 (Linking)
VI  - 200
DP  - 2019 Apr
TI  - Long-term Safety and Ocular Hypotensive Efficacy Evaluation of Netarsudil 
      Ophthalmic Solution: Rho Kinase Elevated IOP Treatment Trial (ROCKET-2).
PG  - 130-137
LID - S0002-9394(19)30012-1 [pii]
LID - 10.1016/j.ajo.2019.01.003 [doi]
AB  - PURPOSE: To evaluate netarsudil 0.02% ophthalmic solution in patients with 
      open-angle glaucoma (OAG) and ocular hypertension (OHT). DESIGN: Double-masked, 
      randomized, multicenter, parallel-group, noninferiority clinical study. METHODS: 
      After a washout of all prestudy ocular hypotensive medications, 756 eligible 
      patients with elevated IOP were randomized to receive netarsudil 0.02% once a day 
      (q.d.) (251); netarsudil 0.02% twice a day (b.i.d.) (254); or timolol 0.5% b.i.d. 
      (251) for 12 months, as well as a noninterventional Corneal Observation Study 
      (COS) for patients manifesting cornea verticillata. RESULTS: On treatment, mean 
      IOP at 8:00 AM decreased from a baseline IOP of 22.5-22.6 mm Hg to 17.9-18.8 mm 
      Hg, 17.2-18.0 mm Hg, and 17.5-17.9 mm Hg for netarsudil q.d., netarsudil b.i.d., 
      and timolol, respectively, over 12 months. The most frequently reported adverse 
      events (AEs) were ocular, with the most frequent ocular AE being conjunctival 
      hyperemia, with an incidence of 61%, 66%, and 14%, respectively. The next most 
      frequent AEs were corneal deposits (corneal verticillata), with an incidence of 
      26%, 25%, and 1%, respectively, and conjunctival hemorrhage (typically 
      petechial), with an incidence of 20%, 19%, and 1%, respectively. All 3 AEs were 
      generally scored as mild, with conjunctival hyperemia and/or hemorrhage appearing 
      sporadically during the study. In the observational follow-up component of this 
      study, there was no clinically meaningful impact of corneal verticillata on 
      visual function in affected patients. CONCLUSIONS: In this randomized, 
      double-masked trial, once-daily dosing of netarsudil 0.02% was effective, 
      consistently lowering IOP through 12 months, and was tolerated by the majority of 
      patients.
CI  - Copyright (c) 2019 The Authors. Published by Elsevier Inc. All rights reserved.
FAU - Kahook, Malik Y
AU  - Kahook MY
AD  - University of Colorado School of Medicine, Aurora, Colorado, USA.
FAU - Serle, Janet B
AU  - Serle JB
AD  - Icahn School of Medicine at Mount Sinai, New York, New York, USA.
FAU - Mah, Francis S
AU  - Mah FS
AD  - Scripps Clinic, La Jolla, California, USA.
FAU - Kim, Terry
AU  - Kim T
AD  - Duke University School of Medicine, Durham, North Carolina, USA.
FAU - Raizman, Michael B
AU  - Raizman MB
AD  - Tufts University School of Medicine, Boston, Massachusetts, USA.
FAU - Heah, Theresa
AU  - Heah T
AD  - Aerie Pharmaceuticals, Inc, Bedminster, New Jersey, USA; Durham, North Carolina, 
      USA.
FAU - Ramirez-Davis, Nancy
AU  - Ramirez-Davis N
AD  - Aerie Pharmaceuticals, Inc, Bedminster, New Jersey, USA; Durham, North Carolina, 
      USA.
FAU - Kopczynski, Casey C
AU  - Kopczynski CC
AD  - Aerie Pharmaceuticals, Inc, Bedminster, New Jersey, USA; Durham, North Carolina, 
      USA.
FAU - Usner, Dale W
AU  - Usner DW
AD  - SDC, Inc, Tempe, Arizona, USA.
FAU - Novack, Gary D
AU  - Novack GD
AD  - PharmaLogic Development, Inc, San Rafael, California, USA; Department of 
      Ophthalmology, University of California Davis School of Medicine, Sacramento, 
      California, USA. Electronic address: gary_novack@pharmalogic.com.
CN  - ROCKET-2 Study Group
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20190115
PL  - United States
TA  - Am J Ophthalmol
JT  - American journal of ophthalmology
JID - 0370500
RN  - 0 (Adrenergic beta-Antagonists)
RN  - 0 (Antihypertensive Agents)
RN  - 0 (Benzoates)
RN  - 0 (Ophthalmic Solutions)
RN  - 11P2JDE17B (beta-Alanine)
RN  - 817W3C6175 (Timolol)
RN  - EC 2.7.11.1 (rho-Associated Kinases)
RN  - W6I5QDT7QI (netarsudil)
SB  - IM
MH  - Administration, Ophthalmic
MH  - Adrenergic beta-Antagonists/administration & dosage/therapeutic use
MH  - Adult
MH  - Aged
MH  - Antihypertensive Agents/administration & dosage/adverse effects/*therapeutic use
MH  - Benzoates/administration & dosage/adverse effects/*therapeutic use
MH  - Double-Blind Method
MH  - Female
MH  - Glaucoma, Open-Angle/diagnosis/*drug therapy/physiopathology
MH  - Humans
MH  - Intraocular Pressure/*drug effects
MH  - Male
MH  - Middle Aged
MH  - Ocular Hypertension/diagnosis/drug therapy/physiopathology
MH  - Ophthalmic Solutions
MH  - Timolol/administration & dosage/therapeutic use
MH  - Treatment Outcome
MH  - beta-Alanine/administration & dosage/adverse effects/*analogs & 
      derivatives/therapeutic use
MH  - rho-Associated Kinases/*antagonists & inhibitors
EDAT- 2019/01/18 06:00
MHDA- 2019/12/18 06:00
CRDT- 2019/01/18 06:00
PHST- 2018/10/01 00:00 [received]
PHST- 2019/01/03 00:00 [revised]
PHST- 2019/01/05 00:00 [accepted]
PHST- 2019/01/18 06:00 [pubmed]
PHST- 2019/12/18 06:00 [medline]
PHST- 2019/01/18 06:00 [entrez]
AID - S0002-9394(19)30012-1 [pii]
AID - 10.1016/j.ajo.2019.01.003 [doi]
PST - ppublish
SO  - Am J Ophthalmol. 2019 Apr;200:130-137. doi: 10.1016/j.ajo.2019.01.003. Epub 2019 
      Jan 15.