TY - JOUR
T1 - A multicenter, open-label study of netarsudil for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension in a real-world setting
AU - Zaman, Fiaz
AU - Gieser, Stephen C.
AU - Schwartz, Gail F.
AU - Swan, Cayla
AU - Williams, Julia M.
N1 - Funding Information:
Medical writing and editorial assistance were provided by BioScience Communications, New York, NY, funded by Aerie Pharmaceuticals, Inc.
Publisher Copyright:
© 2021 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.
PY - 2021
Y1 - 2021
N2 - Objective: Assess the real-world efficacy of netarsudil, either as monotherapy or concomitant therapy, in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT) requiring modification of intraocular pressure (IOP)-lowering treatment. Methods: Multicenter, prospective, interventional, open-label, Phase 4 study, clinical trial registration number: NCT03808688. Netarsudil ophthalmic solution 0.02% was prescribed at the recommended once-daily dosage, with treatment regimens determined by the investigators. Netarsudil could be used alone or in combination with other IOP-lowering medications, consistent with standard clinical practice. Primary efficacy endpoint: percentage reduction from baseline IOP at week 12. Results: Among 261 enrolled patients, 242 received ≥1 netarsudil dose and had ≥1 follow-up IOP measurement (efficacy population). Mean IOP in patients who were treatment-naïve at baseline and using netarsudil as monotherapy (n = 24) decreased by 16.9%. Netarsudil monotherapy was comparable in efficacy to prior therapy across subgroups, and those who replaced prostaglandin analog (n = 57) monotherapy demonstrated reduction of 2.5% from prostaglandin analog-treated baseline values. Among patients who used netarsudil as concomitant therapy (n = 151), reductions in mean IOP (± standard deviation) to week 12 were seen across subgroups who added netarsudil to a single agent (4.3 ± 2.88 mmHg; 20.5%) or ≥2 classes of concomitant therapy (4.5 ± 4.08 mmHg; 20.9%) and who used netarsudil to replace ≥1 other drug classes (0.4 ± 2.47 mmHg; 1.7%). Of 260 netarsudil-treated patients, 41 (15.8%) discontinued, including 29 (11.2%) due to adverse events. Conclusions: In the real-world treatment of patients with OAG or OHT, netarsudil consistently maintained IOP control when it replaced previous IOP-lowering therapies and provided additional IOP-lowering efficacy when added to other treatments.
AB - Objective: Assess the real-world efficacy of netarsudil, either as monotherapy or concomitant therapy, in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT) requiring modification of intraocular pressure (IOP)-lowering treatment. Methods: Multicenter, prospective, interventional, open-label, Phase 4 study, clinical trial registration number: NCT03808688. Netarsudil ophthalmic solution 0.02% was prescribed at the recommended once-daily dosage, with treatment regimens determined by the investigators. Netarsudil could be used alone or in combination with other IOP-lowering medications, consistent with standard clinical practice. Primary efficacy endpoint: percentage reduction from baseline IOP at week 12. Results: Among 261 enrolled patients, 242 received ≥1 netarsudil dose and had ≥1 follow-up IOP measurement (efficacy population). Mean IOP in patients who were treatment-naïve at baseline and using netarsudil as monotherapy (n = 24) decreased by 16.9%. Netarsudil monotherapy was comparable in efficacy to prior therapy across subgroups, and those who replaced prostaglandin analog (n = 57) monotherapy demonstrated reduction of 2.5% from prostaglandin analog-treated baseline values. Among patients who used netarsudil as concomitant therapy (n = 151), reductions in mean IOP (± standard deviation) to week 12 were seen across subgroups who added netarsudil to a single agent (4.3 ± 2.88 mmHg; 20.5%) or ≥2 classes of concomitant therapy (4.5 ± 4.08 mmHg; 20.9%) and who used netarsudil to replace ≥1 other drug classes (0.4 ± 2.47 mmHg; 1.7%). Of 260 netarsudil-treated patients, 41 (15.8%) discontinued, including 29 (11.2%) due to adverse events. Conclusions: In the real-world treatment of patients with OAG or OHT, netarsudil consistently maintained IOP control when it replaced previous IOP-lowering therapies and provided additional IOP-lowering efficacy when added to other treatments.
KW - Glaucoma
KW - clinical trial
KW - intraocular pressure
KW - netarsudil
KW - ocular hypertension
KW - pharmacotherapy
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U2 - 10.1080/03007995.2021.1901222
DO - 10.1080/03007995.2021.1901222
M3 - Article
C2 - 33733980
AN - SCOPUS:85103275889
SN - 0300-7995
VL - 37
SP - 1011
EP - 1020
JO - Current Medical Research and Opinion
JF - Current Medical Research and Opinion
IS - 6
ER -