Drug updated on 12/11/2024
Dosage Form | Topical (ophthalmic solution; netarsudil 0.2 mg/mL [0.02%], latanoprost 0.05 mg/mL [0.005%]) |
Drug Class | Rho kinase inhibitors and prostaglandin F2α analogues |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension
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Summary
- This summary is based on the review of three systematic review(s)/meta-analysis(es). [1-3]
- Fixed-Dose Combination (FDC) Therapy: FDC therapy showed greater Intraocular Pressure (IOP) reduction than latanoprost monotherapy after 2 weeks (mean difference (MD): -2.41 mmHg, 95% confidence interval (CI): -2.95 to -1.87) and after 4–6 weeks (MD: -1.77 mmHg, 95% CI: -2.31 to -1.23). FDC also reduced mean diurnal IOP significantly more than netarsudil monotherapy (MD: -2.36 mmHg, 95% CI: -3.08 to -1.63, P < 0.00001) and latanoprost monotherapy (MD: -1.64 mmHg, 95% CI: -2.05 to -1.23, P < 0.00001).
- FDC therapy achieved a significantly higher percentage reduction in intraocular pressure (IOPR%) compared to netarsudil (MD: 9.60%, 95% CI: 7.86 to 11.33, P < 0.00001) and latanoprost monotherapy (MD: 6.09%, 95% CI: 4.40 to 7.77, P < 0.00001).
- Combination Therapy vs. Monotherapy: Netarsudil/latanoprost combination therapy led to greater IOP reduction compared to monotherapy with latanoprost (MD: -1.64 mmHg, 95% CI: -2.16 to -1.11) or netarsudil (MD: -2.66 mmHg, 95% CI: -2.98 to -2.35). Netarsudil monotherapy was less effective than latanoprost (MD: 0.97 mmHg, 95% CI: 0.67 to 1.27) and timolol (MD: 0.66 mmHg, 95% CI: 0.41 to 0.91).
- Adverse Events (AEs): The risk of conjunctival hyperemia was significantly higher with both FDC therapy and netarsudil monotherapy compared to latanoprost monotherapy (Relative Ratio [RR] for FDC: 3.01, 95% CI: 1.95 to 4.66; for netarsudil: 2.33, 95% CI: 1.54 to 3.54). The incidence of ocular adverse events was higher with netarsudil compared to placebo (66 more AEs per 100 person-months, 95% CI: 28 to 103) and latanoprost (29 more AEs per 100 person-months, 95% CI: 17 to 42).
- Safety of Rho Kinase Inhibitors (ROKi): No specific serious adverse events were associated with ROKi, including netarsudil, across reviewed studies. Most ocular AEs were reported as mild, transient, and reversible upon treatment discontinuation. Combination therapy with netarsudil and latanoprost resulted in more ocular AEs compared to latanoprost monotherapy (29 more events per 100 person-months, 95% CI: 11 to 47).
- There is no population type or subgroup information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Rocklatan (netarsudil and latanoprost) Prescribing Information. | 2023 | Aerie Pharmaceuticals, Inc., Irvine, CA, U.S.A. |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Comparison of Netarsudil/Latanoprost Therapy with Latanoprost Monotherapy for Lowering Intraocular Pressure: A Systematic Review and Meta-analysis | 2022 | Korean Journal of Ophthalmology : Kjo |
Efficacy and safety of netarsudil/latanoprost fixed-dose combination vs. monotherapy in open-angle glaucoma or ocular hypertension: A systematic review and meta-analysis of randomized controlled trials | 2022 | Frontiers in Medicine |
Rho kinase inhibitor for primary open-angle glaucoma and ocular hypertension | 2022 | The Cochrane Database of Systematic Reviews |
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Latanoprost–netarsudil for previously treated primary open-angle glaucoma or ocular hypertension. | 2024 | National Institute for Health and Care Excellence |