Latanoprostene Bunod 0.024% versus Timolol Maleate 0.5% in Subjects with Open-Angle Glaucoma or Ocular Hypertension

Weinreb, Robert N.; Sforzolini, Baldo Scassellati; Vittitow, Jason L; Liebmann, Jeffrey M.

doi:10.1016/j.ophtha.2016.01.019

Cited by 106 publications

(121 citation statements)

References 33 publications

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“…This radical affects an early step in the replication cycle of influenza viruses and NO has been shown to severely impair the replication of influenza A and B viruses 11. In the outflow physiology, NO has been reported to contribute to the physiological regulation of aqueous humor outflow and to lower intraocular pressure in various animal models and human patients 5, 12, 13, 14, 15…”

Section: Introductionmentioning

confidence: 99%

Progress and Promise of Nitric Oxide‐Releasing Platforms

2018

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Nitric oxide (NO) is a highly potent radical with a wide spectrum of physiological activities. Depending on the concentration, it can enhance endothelial cell proliferation in a growth factor‐free medium, mediate angiogenesis, accelerate wound healing, but may also lead to tumor progression or induce inflammation. Due to its multifaceted role, NO must be administered at a right dose and at the specific site. Many efforts have focused on developing NO‐releasing biomaterials; however, NO short half‐life in human tissues only allows this molecule to diffuse over short distances, and significant challenges remain before the full potential of NO can be realized. Here, an overview of platforms that are engineered to release NO via catalytic or noncatalytic approaches is presented, with a specific emphasis on progress reported in the past five years. A number of NO donors, natural enzymes, and enzyme mimics are highlighted, and recent promising developments of NO‐releasing scaffolds, particles, and films are presented. In particular, key parameters of NO delivery are discussed: 1) NO payload, 2) maximum NO flux, 3) NO release half‐life, 4) time required to reach maximum flux, and 5) duration of NO release. Advantages and drawbacks are reviewed, and possible further developments are suggested.

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Section: Introductionmentioning

confidence: 99%

Progress and Promise of Nitric Oxide‐Releasing Platforms

2018

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“…This pivotal randomized, controlled, double-masked trial, evaluated the efficacy and safety of LBN (BOL-303259-X) compared to timolol on a large scale and with a noncrossover design for primary end points 68–71. Four hundred and twenty adult subjects with OHTN or OAG, including pseudoexfoliative and pigmentary glaucoma, at multiple centers throughout the USA and EU were randomized 2:1 to receive either LBN 0.024% once daily at 8 PM or timolol maleate 0.5% BID (8 AM and 8 PM) in the study eye for 3 months.…”

Section: Efficacy and Comparative Studiesmentioning

confidence: 99%

“…These results were pooled with data from the APOLLO study; all subjects demonstrated IOP lowering from baseline over this period (see “APOLLO” section) 68–71…”

Section: Efficacy and Comparative Studiesmentioning

confidence: 99%

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Critical evaluation of latanoprostene bunod in the treatment of glaucoma

Garcia¹,

Ngai²,

Mosaed³

et al. 2016

OPTH

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Latanoprostene bunod (LBN) is a novel nitric oxide-donating prostaglandin F2α receptor agonist in clinical development for intraocular pressure lowering in open-angle glaucoma and ocular hypertension. Currently in Phase III clinical trials in the USA, European Union, and Japan, LBN has demonstrated promising efficacy while maintaining safety and tolerability. We review preclinical and clinical developmental efforts and evaluate the potential role of LBN monotherapy in the management of open-angle glaucoma and ocular hypertension. The current LBN clinical development program comprises eight trials, four of which have resulted in publication of complete methodology and outcomes. We additionally pool adverse events data to determine incidences across three pivotal studies. Evidence thus far indicates that LBN may be a safe and effective ocular hypotensive agent, although the potential neuroprotective effects and the impact on visual field loss remain to be evaluated.

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“…Nitric oxide (NO), a key signaling molecule responsible for mediating a wide array of physiological roles across multiple biological systems, decreases outflow resistance and lowers IOP in various animal models and human patients. [5–13] Due to the therapeutic potential of NO, many efforts have focused on developing NO-donating compounds for glaucoma. In particular, latanoprostene bunod (VESNEO; Bausch and Lomb), a modified version of the existing glaucoma drug latanoprost, contains an NO-donating moiety and is modestly effective at reducing elevated IOP by ≈1.5 mmHg over latanoprost alone in ocular hypertensive patients.…”

mentioning

confidence: 99%

Localized and Controlled Delivery of Nitric Oxide to the Conventional Outflow Pathway via Enzyme Biocatalysis: Toward Therapy for Glaucoma

et al. 2017

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Nitric oxide (NO) is able to lower intraocular pressure (IOP); however, its therapeutic effects on outflow physiology are location‐ and dose‐dependent. A NO delivery platform that directly targets the resistance‐generating region of the conventional outflow pathway and locally liberates a controlled dose of NO is reported. An increase in outflow facility (decrease in IOP) is demonstrated in a mouse model.

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Latanoprostene Bunod 0.024% versus Timolol Maleate 0.5% in Subjects with Open-Angle Glaucoma or Ocular Hypertension

Abstract: In this phase 3 study, LBN 0.024% qpm demonstrated significantly greater IOP lowering than timolol 0.5% BID throughout the day over 3 months of treatment. Latanoprostene bunod 0.024% was effective and safe in these adults with OAG or OHT.

Cited by 106 publications

References 33 publications

Progress and Promise of Nitric Oxide‐Releasing Platforms

Progress and Promise of Nitric Oxide‐Releasing Platforms

Critical evaluation of latanoprostene bunod in the treatment of glaucoma

Localized and Controlled Delivery of Nitric Oxide to the Conventional Outflow Pathway via Enzyme Biocatalysis: Toward Therapy for Glaucoma

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