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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.
Asrani, Sanjay; Bacharach, Jason; Holland, Edward; McKee, Hayley; Sheng, Huan; Lewis, Richard A; Kopczynski, Casey C; Heah, Theresa.
Afiliación
  • Asrani S; Duke University School of Medicine, Durham, NC, USA. sanjay.asrani@duke.edu.
  • Bacharach J; North Bay Eye Associates, Petaluma, CA, USA.
  • Holland E; Cincinnati Eye Institute, Cincinnati, OH, USA.
  • McKee H; Aerie Pharmaceuticals, Inc, Durham, NC, USA.
  • Sheng H; Aerie Pharmaceuticals, Inc, Durham, NC, USA.
  • Lewis RA; Aerie Pharmaceuticals, Inc, Durham, NC, USA.
  • Kopczynski CC; Sacramento Eye Consultants, Sacramento, CA, USA.
  • Heah T; Aerie Pharmaceuticals, Inc, Durham, NC, USA.
Adv Ther ; 37(4): 1620-1631, 2020 04.
Article en En | MEDLINE | ID: mdl-32166538
In patients with open-angle glaucoma (OAG) or ocular hypertension (OHT), treatment to lower intraocular pressure (IOP) is needed to prevent optic nerve damage and vision loss. Many patients do not achieve sufficient IOP lowering with a single drug. The use of multiple IOP-lowering agents, which may have different dose regimens, can be complex and reduce patient adherence. Combination treatments that incorporate multiple agents are available, but until recently none included a prostaglandin analogue, the most widely prescribed first-line therapy. A once-daily, fixed-dose combination (FDC) therapy (ROCKLATAN®) has been approved in the USA that contains the prostaglandin analogue latanoprost and netarsudil, a novel Rho kinase inhibitor. The netarsudil/latanoprost FDC demonstrated efficacy and safety in lowering IOP among patients with OAG and OHT in the 12-month MERCURY-1 and the 3-month MERCURY-2 clinical trials. To better characterize efficacy and safety, we pooled and analyzed the data from each trial. The pooled data support the findings of the individual studies:Efficacy: 1. Netarsudil/latanoprost FDC demonstrated statistical superiority to the individual components netarsudil and latanoprost in decreasing IOP at all time points assessed over 3 months. 2. Nearly twice as many patients receiving FDC achieved at least a 30% reduction from baseline in IOP, as recommended by the American Academy of Ophthalmology for a first-line treatment, compared to the IOP reduction achieved by netarsudil and latanoprost monotherapy.Safety: No new safety signals were identified. Netarsudil/latanoprost FDC was associated with no treatment-related serious adverse events, minimal systemic adverse events, and manageable ocular adverse events.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Soluciones Oftálmicas / Benzoatos / Glaucoma de Ángulo Abierto / Hipertensión Ocular / Beta-Alanina / Latanoprost / Antihipertensivos Tipo de estudio: Clinical_trials / Prognostic_studies Límite: Aged / Female / Humans / Male / Middle aged País/Región como asunto: America do norte Idioma: En Revista: Adv Ther Asunto de la revista: TERAPEUTICA Año: 2020 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Soluciones Oftálmicas / Benzoatos / Glaucoma de Ángulo Abierto / Hipertensión Ocular / Beta-Alanina / Latanoprost / Antihipertensivos Tipo de estudio: Clinical_trials / Prognostic_studies Límite: Aged / Female / Humans / Male / Middle aged País/Región como asunto: America do norte Idioma: En Revista: Adv Ther Asunto de la revista: TERAPEUTICA Año: 2020 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos