Preservative-free bimatoprost 0.03% in patients with primary open-angle glaucoma or ocular hypertension in clinical practice

Lutz E Pillunat, Peter Eschstruth, Stefan Häsemeyer, Ulrich Thelen, Christian Foja, Richard Leaback, Stefan Pfennigsdorf, Lutz E Pillunat, Peter Eschstruth, Stefan Häsemeyer, Ulrich Thelen, Christian Foja, Richard Leaback, Stefan Pfennigsdorf

Abstract

Background: Intraocular pressure (IOP)-lowering medications for primary open-angle glaucoma and ocular hypertension commonly contain preservatives that can cause ocular surface damage in many patients. The purpose of this study was to evaluate the efficacy and tolerability of, and compliance to, preservative-free (PF) bimatoprost 0.03% in patients with primary open-angle glaucoma or ocular hypertension (IOP ≥18 mmHg) in a clinical practice setting.

Methods: This open-label study observed patients who were switched to PF bimatoprost 0.03% for medical reasons. IOP was measured at baseline and ~12 weeks later at the final visit, and the change in IOP was calculated. Tolerability and continuation of therapy were assessed at two follow-up visits.

Results: A total of 1,830 patients were included in the study, and complete IOP data were available for 1,543 patients. Mean IOP was reduced by 23% from 21.64 mmHg to 16.59 mmHg (P<0.0001). In subgroup analyses, the mean IOP was significantly reduced compared with baseline, regardless of prior therapy, including those previously treated with PF monotherapy. A total of 85.7% of physicians reported the IOP-lowering efficacy of PF bimatoprost 0.03% to be as expected or better than expected. Adverse events (AEs) were experienced by 5.7% of patients, and there were no serious AEs reported. The most common AEs were eye irritation (1.7%) and hyperemia (1.4%). Physician-reported treatment compliance was reported as better than (48.7%) or equal to (43.6%) prior treatment in most patients. Most patients (82%) were expected to continue PF bimatoprost 0.03% after the end of the study.

Conclusion: This observational study showed that, in clinical practice, switching to PF bimatoprost 0.03% was associated with a significant IOP reduction from baseline. There was a low AE rate. PF bimatoprost 0.03% may, therefore, be an effective treatment option for patients who are intolerant of preservatives or have an inadequate response to prior IOP-lowering treatments.

Keywords: benzalkonium chloride free; bimatoprost 0.03%; intraocular pressure; preservative free; prostaglandin.

Figures

Figure 1
Figure 1
Prior intraocular pressure-lowering therapy reported in ≥2% of patients. Notes: Medications as listed by treating physician. The figure includes patients receiving both monotherapy and combination therapy (n=1,620). Abbreviations: NS, not specified; P, preserved; PF, preservative free.
Figure 2
Figure 2
Overall mean ± SD IOP in patients who switched from a prior IOP-lowering therapy to preservative-free bimatoprost 0.03% monotherapy. Notes: Data reported for patients with complete data (n=1,543 at both visits). **P<0.0001. Abbreviation: IOP, intraocular pressure.
Figure 3
Figure 3
Mean ± SD IOP in patients switched from a prior IOP-lowering monotherapy to PF bimatoprost 0.03% monotherapy. Notes: Data reported for patients with complete data. *P<0.0001. Abbreviations: excl, excluding; IOP, intraocular pressure; lat, latanoprost; monopr, monoprost; P, preserved; PF, preservative free; PGA, prostaglandin analog; taf, tafluprost; tim, timolol; trav, travoprost.

References

    1. Freeman EE, Munoz B, West SK, Jampel HD, Friedman DS. Glaucoma and quality of life: the Salisbury eye evaluation. Ophthalmology. 2008;115(2):233–238.
    1. European Glaucoma Society . Terminology and Guidelines for Glaucoma. 4th ed. Savona, Italy: PubliComm; 2014.
    1. Haymes SA, LeBlanc RP, Nicolela MT, Chiasson LA, Chauhan BC. Risk of falls and motor vehicle collisions in glaucoma. Invest Ophthalmol Vis Sci. 2007;48(3):1149–1155.
    1. Ramulu PY, West SK, Munoz B, Jampel HD, Friedman DS. Driving cessation and driving limitation in glaucoma: the Salisbury eye evaluation project. Ophthalmology. 2009;116(10):1846–1853.
    1. van der Valk R, Webers CA, Lumley T, Hendrikse F, Prins MH, Schouten JS. A network meta-analysis combined direct and indirect comparisons between glaucoma drugs to rank effectiveness in lowering intraocular pressure. J Clin Epidemiol. 2009;62(12):1279–1283.
    1. Baudouin C, Labbe A, Liang H, Pauly A, Brignole-Baudouin F. Preservatives in eyedrops: the good, the bad and the ugly. Prog Retin Eye Res. 2010;29(4):312–334.
    1. International Dry Eye Workshop Report of the international dry eye workshop (DEWS) Ocul Surf. 2007;5(2):61–204.
    1. Stalmans I, Megevand SG, Cordeiro F, et al. Preservative-free treatment in glaucoma: who, when, and why. Eur J Ophthalmol. 2013;23(4):518–525.
    1. Hommer A, Kimmich F. Switching patients from preserved prostaglandin-analog monotherapy to preservative-free tafluprost. Clin Ophthalmol. 2011;5:623–631.
    1. Day DG, Walters TR, Schwartz GF, et al. Bimatoprost 0.03% preservative-free ophthalmic solution versus bimatoprost 0.03% ophthalmic solution (Lumigan) for glaucoma or ocular hypertension: a 12-week, randomised, double-masked trial. Br J Ophthalmol. 2013;97(8):989–993.
    1. Allergan Ltd [webpage on the Internet] Lumigan 0.3 mg/ml Summary of Product Characteristics. electronic Medicines Compendium (eMC) 2014. [Accessed August 16, 2015]. Available from:
    1. van der Valk V, Webers CA, Schouten JS, Zeegers MP, Hendrikse F, Prins MH. Intraocular pressure-lowering effects of all commonly used glaucoma drugs: a meta-analysis of randomized clinical trials. Ophthalmology. 2005;112(7):1177–1185.
    1. Aptel F, Cucherat M, Denis P. Efficacy and tolerability of prostaglandin analogs: a meta-analysis of randomized controlled clinical trials. J Glaucoma. 2008;17(8):667–673.
    1. Day D, Walters TR, Schwartz G, et al. Bimatoprost 0.03% preservative-free ophthalmic solution versus bimatoprost 0.03% ophthalmic solution (Lumigan) for glaucoma or ocular hypertension: a 12-week, double-masked trial; Poster presented at: European Glaucoma Society Congress; Copenhagen, Denmark: 2012.
    1. Liang H, Pauly A, Riancho L, Baudouin C, Brignole-Baudouin F. Toxicological evaluation of preservative-containing and preservative-free prostaglandin analogs on the 3D-reconstituted corneal epithelium (SkinEthic) system. Br J Ophthalmol. 2011;95(6):869–875.
    1. Eschstruth P, Pfennigsdorf S. Comparison of the IOP-lowering efficacy of BAK-preserved Travatan versus polyquad-preserved Travatan; German Ophthalmological Society Congress; Berlin: 2013. Abstract PSa09–PSa10.
    1. Labbe A, Terry O, Brasnu E, Van WC, Baudouin C. Tear film osmolarity in patients treated for glaucoma or ocular hypertension. Cornea. 2012;31(9):994–999.
    1. International Dry Eye Workshop The definition and classification of dry eye disease: report of the Definition and Classification Subcommittee of the International Dry Eye WorkShop (2007) Ocul Surf. 2007;5(2):75–92.
    1. Tomlinson A, Khanal S, Ramaesh K, Diaper C, McFadyen A. Tear film osmolarity: determination of a referent for dry eye diagnosis. Invest Ophthalmol Vis Sci. 2006;47(10):4309–4315.
    1. Jaenen N, Baudouin C, Pouliquen P, Manni G, Figueiredo A, Zeyen T. Ocular symptoms and signs with preserved and preservative-free glaucoma medications. Eur J Ophthalmol. 2007;17(3):341–349.
    1. Pisella PJ, Pouliquen P, Baudouin C. Prevalence of ocular symptoms and signs with preserved and preservative free glaucoma medication. Br J Ophthalmol. 2002;86(4):418–423.

Source: PubMed

Sponsorer och medarbetare

Medicinska tillstånd

Läkemedelsinterventioner

3
Prenumerera