Dataset Information

Critical evaluation of latanoprostene bunod in the treatment of glaucoma.

ABSTRACT: Latanoprostene bunod (LBN) is a novel nitric oxide-donating prostaglandin F2? 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.

SUBMITTER: Garcia GA

PROVIDER: S-EPMC5079698 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Critical evaluation of latanoprostene bunod in the treatment of glaucoma.

Garcia Giancarlo A GA Ngai Philip P Mosaed Sameh S Lin Ken Y KY

Clinical ophthalmology (Auckland, N.Z.) 20161018

Latanoprostene bunod (LBN) is a novel nitric oxide-donating prostaglandin F<sub>2α</sub> 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 o ...[more]

PMID: 27799730

Similar Datasets

Project description:IntroductionLatanoprostene bunod (LBN) is a novel nitric oxide (NO)-donating prostaglandin F2α analog. We evaluated the long-term safety and intraocular pressure (IOP)-lowering efficacy of LBN ophthalmic solution 0.024% over 1 year in Japanese subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT).MethodsThis was a single-arm, multicenter, open-label, clinical study. Subjects aged 20 years and older with a diagnosis of OAG or OHT instilled 1 drop of LBN ophthalmic solution 0.024% in the affected eye(s) once daily in the evening for 52 weeks and were evaluated every 4 weeks. Safety assessments included vital signs, comprehensive ophthalmic exams, and treatment-emergent adverse events (AEs). Absolute and percent reductions from baseline in IOP were also determined.ResultsOf 130 subjects enrolled, 121 (93.1%) completed the study. Mean age was 62.5 years, and mean (standard deviation) baseline IOP was 19.6 (2.9) and 18.7 (2.6) mmHg in study eyes and treated fellow eyes, respectively. Overall, 76/130 (58.5%) and 78/126 (61.9%) subjects experienced ≥1 AEs in study eyes and treated fellow eyes, respectively. In both study eyes and treated fellow eyes, the most common AEs were conjunctival hyperemia, growth of eyelashes, eye irritation, and eye pain. At 52 weeks, 9% of treated eyes had an increase in iris pigmentation compared with baseline based on iris photographs. No safety concerns emerged based on vital signs or other ocular assessments. Mean reductions from baseline in IOP of 22.0% and 19.5% were achieved by week 4 in study and treated fellow eyes, respectively. These reductions were maintained through week 52 (P < 0.001 vs. baseline at all visits).ConclusionOnce daily LBN ophthalmic solution 0.024% was safe and well-tolerated in Japanese subjects with OAG or OHT when used for up to 1 year. Long-term treatment with LBN ophthalmic solution 0.024% provided significant and sustained IOP reduction.Trial registrationClinicalTrials.gov identifier, NCT01895972.FundingBausch & Lomb, Inc. a division of Valeant Pharmaceuticals International Inc.

Dataset Information

Critical evaluation of latanoprostene bunod in the treatment of glaucoma.

Publications

Critical evaluation of latanoprostene bunod in the treatment of glaucoma.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure