Fixed-Dose Combination of Netarsudil and Latanoprost in Ocular Hypertension and Open-Angle Glaucoma: Pooled Efficacy/Safety Analysis of Phase 3 MERCURY-1 and -2

Asrani, Sanjay; Bacharach, Jason; Holland, Edward J.; McKee, Hayley; Sheng, Huan; Lewis, Richard A.; Kopczynski, Casey; Heah, Theresa

doi:10.1007/s12325-020-01277-2

Cited by 57 publications

(55 citation statements)

References 18 publications

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“…Although approximately onethird of subjects experienced treatment-related adverse events (most commonly, conjunctival hyperemia), none of these were serious adverse events, and only 11% of subjects discontinued the study due to adverse events. The discontinuation rate is comparable to the 3-month netarsudil dropout rates from the pooled ROCKET monotherapy trials (66/ 494 subjects [13.4%]) and the pooled monotherapy arms of the MERCURY-1 and 2 trials (70/499 subjects [14.0%]) 29,30 . Hyperemia was generally mild and sporadic, with only 1 case of severe hyperemia.…”

Section: Discussionmentioning

confidence: 61%

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

Zaman

Gieser

Schwartz

et al. 2021

Current Medical Research and Opinion

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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 ¼ 24) decreased by 16.9%. Netarsudil monotherapy was comparable in efficacy to prior therapy across subgroups, and those who replaced prostaglandin analog (n ¼ 57) monotherapy demonstrated reduction of 2.5% from prostaglandin analog-treated baseline values. Among patients who used netarsudil as concomitant therapy (n ¼ 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.

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Section: Discussionmentioning

confidence: 61%

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

Zaman

Gieser

Schwartz

et al. 2021

Current Medical Research and Opinion

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“… 21 The most common adverse event was conjunctival hyperemia (63%), followed by instillation site pain (23%), conjunctival hemorrhage (13%), and cornea verticillata (17.6%). 21 …”

Section: Rock Inhibitors and Their Role In Glaucomamentioning

confidence: 99%

“…PG324: In 2019, Aerie Pharmaceuticals also introduced PG324 (Rocklatan ® ), an FDA approved fixed-dose combination of Netarsudil (0.02%) and latanoprost (0.005%). 21 Two Phase 3 studies (MERCURY 1 and MERCURY 2) showed that this combination significantly lowered IOP and was superior to both Netarsudil and latanoprost alone. 21 The most common adverse event was conjunctival hyperemia (63%), followed by instillation site pain (23%), conjunctival hemorrhage (13%), and cornea verticillata (17.6%).…”

Section: Rock Inhibitors and Their Role In Glaucomamentioning

confidence: 99%

“… 21 Two Phase 3 studies (MERCURY 1 and MERCURY 2) showed that this combination significantly lowered IOP and was superior to both Netarsudil and latanoprost alone. 21 The most common adverse event was conjunctival hyperemia (63%), followed by instillation site pain (23%), conjunctival hemorrhage (13%), and cornea verticillata (17.6%). 21 …”

Section: Rock Inhibitors and Their Role In Glaucomamentioning

confidence: 99%

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Investigational Rho Kinase Inhibitors for the Treatment of Glaucoma

Al-Humimat¹,

Marashdeh²,

Daradkeh³

et al. 2021

JEP

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This review provides a comprehensive update on emerging ROCK inhibitors as an innovative treatment option for lowering intraocular pressure (IOP) in glaucoma and aims to describe the structure, mechanism of action, pharmaceutical characteristics, desirable ocular effects, including side effects for each agent. A literature review was conducted using PubMed, Scopus, clinicaltrials.gov, ARVO journals, Cochrane library and Selleckchem. Databases were searched using “investigational Rho kinase inhibitors,” and “glaucoma” as keywords. In addition to this building block strategy, successive fractions were employed to further refine the results. Of the several ROCK inhibitors discovered, only two drugs are currently approved for glaucoma treatment; Netarsudil in the USA and Ripasudil in Japan and China. We identified and reviewed 15 agents currently in laboratory or clinical trials. These agents lower IOP mainly by decreasing outflow resistance through pharmacologic relaxation of the trabecular meshwork (TM) cells and reducing episcleral venous pressure. They have an optimistic safety profile; however, conjunctival hyperemia, conjunctival hemorrhage, pain on instillation, and corneal verticillata are common. Other properties such as neuroprotection (enhancing optic nerve blood flow and promoting axonal regeneration), anti-fibrotic activity, and endothelial cell proliferation may improve the visual prognosis and surgical outcomes in glaucoma. In addition, these agents have the potential to work synergistically with other topical glaucoma medications.

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“…Both of the triple FDC showed no serious adverse events and they were reported to be as safe as and well tolerated as bimatoprost/timolol FC and dorzolamide/timolol FC [66]. Soon after the development of netarsudil, Aerie Pharmaceuticals Inc (Durham, NC, USA) developed an FDC combining netarsudil and latanoprost and has recently been tested in two Phase III clinical trials, MERCURY-1 and MERCURY-2 [70]- [72]. The most commonly reported adverse event was conjunctival hyperaemia and the FDC otherwise has negligible treatment-related serious local or systemic adverse drug reactions.…”

Section: Combination Treatmentmentioning

confidence: 99%

Medical Management of Open-Angle Glaucoma: Focus on Mechanisms of Action and Adverse Drug Reactions

Razali¹,

Hassan²,

Bakar³

et al. 2021

JCHS

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Glaucoma is an optic neuropathy characterised by optic nerve degeneration associated with visual field defects. It remains the world’s number one cause of irreversible blindness and patients usually present at late stage of the disease since it is generally asymptomatic until severe. The disease is subdivided into primary and secondary with primary open-angle glaucoma (POAG) being the most common type. At present, lowering the intraocular pressure (IOP) remains the only proven efficient approach in delaying the onset or preventing the progression of the disease. Medical treatment with topical antiglaucoma agents is the treatment of choice in open angle glaucoma. The use of antiglaucoma drugs aims to reduce IOP by enhancing aqueous humour (AH) outflow, reducing AH production, or both. The choice to use any available treatment option should be carefully considered in an attempt to maximise benefits and reducing the risk of developing adverse drug reactions. This review highlights the six classes of ocular hypotensive agents currently in use for POAG treatment including prostaglandin analogues; B-adrenergic receptor blockers; a-2 adrenergic receptor stimulants; carbonic anhydrase inhibitors; muscarinic receptor stimulants; rho kinase inhibitors with regards to their mechanism/s of action and potential adverse drug reactions, and antiglaucoma fixed drug combinations.

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Fixed-Dose Combination of Netarsudil and Latanoprost in Ocular Hypertension and Open-Angle Glaucoma: Pooled Efficacy/Safety Analysis of Phase 3 MERCURY-1 and -2

Cited by 57 publications

References 18 publications

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

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

Investigational Rho Kinase Inhibitors for the Treatment of Glaucoma

Medical Management of Open-Angle Glaucoma: Focus on Mechanisms of Action and Adverse Drug Reactions

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