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Netarsudil/latanoprost fixed-dose combination for the treatment of open-angle glaucoma or ocular hypertension

机译：Netarsudil / Latanoprost固定剂量组合用于治疗开口角度青光眼或眼高血压

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摘要

The fixed-dose combination (FDC) of netarsudil 0.02%/latanoprost 0.005% was approved by the United States Food and Drug Administration (FDA) on March 12, 2019, for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) and ocular hypertension (OHT). Netarsudil is a Rho kinase (ROCK) inhibitor and latanoprost is a prostaglandin analogue (PGA). Once-daily administration of this FDC reduces IOP by enhancing aqueous outflow through both the trabecular pathways (ROCK inhibition) and uveoscleral pathways (PGA). Two phase III clinical trials, MERCURY-1 and MERCURY-2, confirmed significantly greater efficacy of the FDC than the individual components, with IOP reductions of 30% or greater observed in 59-65% of subjects treated with FDC compared with 29-37% of subjects treated with latanoprost alone and 21-29% of subjects treated with netarsudil alone. The FDC was well tolerated with mostly mild ocular side effects and limited systemic side effects. This paper will review the work leading to FDA approval and the clinical indications for the use of this combination.
机译：Netarsudil的固定剂量组合（FDC）0.02％/ Latanoprost 0.005％由美国食品和药物管理局（FDA）于3月12日批准，于2019年3月12日批准，用于减少开放角度患者的眼压（IOP）青光眼（OAG）和眼高血压（OHT）。 Netarsudil是rho激酶（岩）抑制剂，Latanoprost是前列腺素类似物（PGA）。每日每日施用该FDC通过通过小梁途径（岩石抑制）和乌肺途径（PGA）增强含水流出来减少IOP。两期III期临床试验，汞-1和汞-2，证实FDC的疗效明显高于各个组分，IOP减少在59-65％的FDC治疗的受试者中观察到30％或更高，而与29-37相比单独用Latanoproprost治疗的受试者的百分比单独治疗21-29％的受试者。 FDC具有良好的耐受性，大多数轻度眼睛副作用和有限的系统性副作用。本文将审查导致FDA批准的工作以及使用这种组合的临床适应症。

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