Bimatoprost 0.01% vs bimatoprost 0.03%: a 12-month prospective trial of clinical and in vivo confocal microscopy in glaucoma patients

Figus, Michele; Nardi, Marco; Piaggi, Paolo; Sartini, Maria Sole; Guidi, G. M.; Martini, L.; Lazzeri, Stefano

doi:10.1038/eye.2013.304

Cited by 27 publications

(31 citation statements)

References 44 publications

(47 reference statements)

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“…Additionally, while BAK is known to be associated with ocular side effects such as conjunctival hyperemia, several studies have shown milder and/or fewer reports of conjunctival hyperemia after treatment with bimatoprost 0.01% in BAK 200 ppm, compared with bimatoprost 0.03% in BAK 50 ppm. 21 , 24 , 30 , 31 These findings suggest that a higher BAK concentration does not necessarily lead to a higher rate of conjunctival hyperemia.…”

Section: Clinical Correlation With Evidence For Use Of Bimatoprost Twmentioning

confidence: 85%

“…15 In two identically designed, Phase III pivotal studies supporting the efficacy and safety of bimatoprost 0.03% ophthalmic solution (preserved with 50 ppm benzalkonium chloride [BAK]), once-daily dosing was found to be optimal for a monotherapy formulation, with twice-daily dosing offering no efficacy advantage. 16 – 20 The currently available bimatoprost 0.01% formulation (containing 200 ppm BAK) has been found to be as effective as the 0.03% formulation when administered once daily, 21 – 24 most likely because higher BAK concentrations were shown to enhance corneal penetration of bimatoprost. 25…”

Section: Introductionmentioning

confidence: 99%

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Ocular pharmacokinetics and tolerability of bimatoprost ophthalmic solutions administered once or twice daily in rabbits, and clinical dosing implications

Shen¹,

Goodkin²,

Tong³

et al. 2017

OPTH

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PurposeFixed-combination medications can benefit patients requiring multiple agents to lower their intraocular pressure (IOP), but combining agents with complementary mechanisms of action is challenging if their dosing frequency differs. This study compares in vivo pharmacokinetic and ocular tolerability of bimatoprost 0.01% ophthalmic solutions dosed once or twice daily. Reports of twice-daily dosing in glaucoma patients are also reviewed.MethodsNew Zealand White rabbits were administered bimatoprost 0.01% monotherapy or fixed-combination bimatoprost 0.01%/brimonidine 0.1%, once or twice daily in both eyes for 4 days. Ocular tissues were harvested and analyzed by liquid chromatography-tandem mass spectrometry. The pharmacokinetic parameters calculated included maximum observed concentration, time to maximum concentration, and area under the concentration-time curve.ResultsDue to extensive metabolism, bimatoprost concentration was below the quantitation limit by 1 hour post-dose in all samples. Bimatoprost acid exposure, however, could be measured up to 6–8 hours post-dose and was similar in the aqueous humor and iris-ciliary body (pharmacological site of action) of animals treated once or twice daily with either bimatoprost 0.01% or fixed-combination bimatoprost 0.01%/brimonidine 0.1%. Increasing dosage frequency in rabbits did not raise the incidence of drug-related conjunctival hyperemia (most common adverse event associated with bimatoprost use in humans), suggesting comparable ocular tolerability of the once- and twice-daily regimens for each formulation.ConclusionBimatoprost 0.01% administered once or twice daily as monotherapy and in fixed-combination with brimonidine 0.1% in rabbits show similar pharmacokinetic profiles of bimatoprost acid, especially in the iris-ciliary body. Key findings from previous clinical studies suggest that by varying the concentration of benzalkonium chloride (a preservative with corneal penetration-enhancing properties), formulations of bimatoprost 0.01% can be administered once or twice daily. These findings support development of bimatoprost 0.01%-based fixed-dose combination therapies administered twice daily for patients who require multiple adjunctive medications to control their IOP.

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Section: Clinical Correlation With Evidence For Use Of Bimatoprost Twmentioning

confidence: 85%

Section: Introductionmentioning

confidence: 99%

Ocular pharmacokinetics and tolerability of bimatoprost ophthalmic solutions administered once or twice daily in rabbits, and clinical dosing implications

Shen¹,

Goodkin²,

Tong³

et al. 2017

OPTH

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“… 14 Bimatoprost 0.01% has demonstrated equivalent IOP-lowering efficacy and improved tolerability compared with bimatoprost 0.03%, including less frequent and severe conjunctival hyperemia. 8 , 12 The study by Katz et al confirmed that bimatoprost 0.01% is effective and equivalent to bimatoprost 0.03% in lowering IOP over a 12-month treatment period. 8 …”

Section: Discussionmentioning

confidence: 97%

A combined analysis of four observational studies evaluating the intraocular pressure-lowering ability and tolerability of bimatoprost 0.01% in patients with primary open-angle glaucoma or ocular hypertension

Stevens

Iliev

Jong

et al. 2016

OPTH

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Objective Combine and evaluate data from four clinical practice studies investigating the intraocular pressure (IOP)-lowering ability, tolerability of and patient adherence to bimatoprost 0.01% therapy in patients with primary open-angle glaucoma or ocular hypertension. Methods Data were combined from four multicenter, prospective, observational studies. Patients (n=2,593) were recruited from 328 sites in Austria, Belgium, Switzerland, and the Netherlands. Assessments were at study entry (baseline) and after 10–14 weeks. Results Bimatoprost 0.01% lowered mean IOP by 5.0 mmHg from baseline to final visit ( P <0.0001). Individual IOP goals were achieved in 75.5% of patients. Results were similar in right and left eyes; right-eye data are presented here for brevity. The greatest mean IOP reduction was 6.7±4.7 mmHg (28.8% reduction from baseline to final visit, P <0.0001) in treatment-naïve patients. Switching to bimatoprost 0.01% monotherapy from previous monotherapy reduced mean IOP by a further 3.2±3.6 mmHg (17.2%, P <0.0001). Switching to bimatoprost 0.01% from previous prostaglandin monotherapy reduced mean IOP by 2.9±3.5 mmHg (15.5%), including by 3.1±3.4 mmHg (15.8%) and 3.3±4.1 mmHg (16.9%) for previous latanoprost and travoprost treatment, respectively (all P <0.0001). IOP reduction in patients previously treated with a fixed combination was 2.7±4.0 mmHg (14.2%, P <0.0001). The most commonly reported adverse events were conjunctival hyperemia (5.2%) and eye irritation (4.7%). Tolerability was rated as “very good” or “good” by 90.1% of patients. Adherence was rated by physicians as “better than” or “equal to” previous treatment in 97.2% of patients. Conclusion The combined studies demonstrated in a clinical practice setting, bimatoprost 0.01% lowered IOP effectively in treatment-naïve and previously treated ocular hypertension and primary open-angle glaucoma patients, and was associated with good tolerability and patient adherence over 12 weeks.

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“…The efficacy observed in the topical treatment arm was consistent with the 30%-35% IOP lowering typically reported in studies of topical bimatoprost 0.03%. 21 A bimatoprost 0.01% formulation that demonstrates the same efficacy and improved tolerability 22,23 is now the only topical ophthalmic formulation of bimatoprost available for use in the United States.…”

Section: This Is the First Report Of The Iop-lowering Efficacymentioning

confidence: 99%

Bimatoprost Sustained-Release Implants for Glaucoma Therapy: 6-Month Results From a Phase I/II Clinical Trial

Lewis¹,

Christie²,

Day³

et al. 2017

American Journal of Ophthalmology

105

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Bimatoprost 0.01% vs bimatoprost 0.03%: a 12-month prospective trial of clinical and in vivo confocal microscopy in glaucoma patients

Cited by 27 publications

References 44 publications

Ocular pharmacokinetics and tolerability of bimatoprost ophthalmic solutions administered once or twice daily in rabbits, and clinical dosing implications

Ocular pharmacokinetics and tolerability of bimatoprost ophthalmic solutions administered once or twice daily in rabbits, and clinical dosing implications

A combined analysis of four observational studies evaluating the intraocular pressure-lowering ability and tolerability of bimatoprost 0.01% in patients with primary open-angle glaucoma or ocular hypertension

Bimatoprost Sustained-Release Implants for Glaucoma Therapy: 6-Month Results From a Phase I/II Clinical Trial

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