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Preservative-Free Latanoprost Eye Drops in Patients with Primary Open-Angle Glaucoma/Ocular Hypertension

Clinical Drug Investigation volume 34, pages 521–528 (2014)Cite this article

Abstract

Latanoprost is an ester prodrug prostaglandin F2α analogue that is a selective agonist of endogenous prostanoid FP receptors and that reduces intraocular pressure (IOP) by increasing the uveoscleral outflow of aqueous humour. Preservative-free (PF) latanoprost [Monoprost®] is a new formulation of latanoprost that is approved for use in the EU in patients with primary open-angle glaucoma (POAG)/ocular hypertension. This article reviews the clinical pharmacology of this new formulation, focussing on its efficacy and tolerability in this indication. PF latanoprost was efficacious in reducing IOP in a randomized, investigator-masked, multinational trial in patients with POAG/ocular hypertension (n = 404). At days 15, 42 and 84 of follow-up, PF latanoprost was noninferior to benzalkonium chloride-preserved (BAK) latanoprost in terms of reductions in IOP. In this trial, at days 42 and 84 the proportions of patients with conjunctival hyperaemia were significantly lower with PF latanoprost than with BAK latanoprost. Patient subjective ratings of ocular symptoms were also significantly lower with PF latanoprost than with BAK latanoprost. In the absence of head-to-head comparisons with other anti-glaucoma drugs, an adjusted, indirect comparison meta-analysis was performed using data from 21 randomized clinical trials in patients with POAG/ocular hypertension. Based on this analysis, PF latanoprost had similar efficacy to different formulations of three comparator prostaglandin analogues in reducing the patient’s IOP and was associated with a significantly lower risk of developing hyperaemia/ocular redness than these comparators. PF latanoprost offers a useful alternative to the available preserved prostaglandin analogues for the treatment of POAG/ocular hypertension.

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References

  1. Boland MV, Ervin A-M, Friedman DS, et al. Comparative effectiveness of treatments for open-angle glaucoma: a systematic review for the US Preventive Services Task Force. Ann Intern Med. 2013;158(4):271–9.

    PubMed  Article  Google Scholar 

  2. Perry CM, McGavin JK, Culy CR, et al. Latanoprost: an update of its use in glaucoma and ocular hypertension. Drugs Aging. 2003;20(8):597–630.

    CAS  PubMed  Article  Google Scholar 

  3. American Academy of Ophthalmology. Primary open-angle glaucoma preferred practice pattern. 2010. http://one.aao.org/preferred-practice-pattern/primary-openangle-glaucoma-ppp–october-2010. Accessed 16 Apr 2014.

  4. European Glaucoma Society. Terminology and guidelines for glaucoma (3rd Edition). 2008. http://www.eugs.org/eng/EGS_guidelines.asp. Accessed 16 Apr 2014.

  5. National Institute for Health and Care Excellence. Glaucoma: diagnosis and management of chronic open angle glaucoma and ocular hypertension (NICE clinical guideline 85). 2009. http://www.nice.org.uk/nicemedia/live/12145/43839/43839.pdf. Accessed 16 Apr 2014.

  6. American Academy of Ophthalmology. Primary open-angle glaucoma summary benchmark. 2013. http://one.aao.org/summary-benchmark-detail/primary-openangle-glaucoma-summary-benchmark–octo. Accessed 16 Apr 2014.

  7. Honrubia F, Garcia-Sanchez J, Polo V, et al. Conjunctival hyperaemia with the use of latanoprost versus other prostaglandin analogues in patients with ocular hypertension or glaucoma: a meta-analysis of randomised clinical trials. Br J Ophthalmol. 2009;93(3):316–21.

    CAS  PubMed Central  PubMed  Article  Google Scholar 

  8. Arias A, Schargel K, Ussa F, et al. Patient persistence with first-line antiglaucomatous monotherapy. Clin Ophthalmol. 2010;4:261–7.

    PubMed Central  PubMed  Google Scholar 

  9. Baudouin C, Labbe A, Liang H, et al. Preservatives in eyedrops: the good, the bad and the ugly. Prog Retin Eye Res. 2010;29(4):312–34.

    CAS  PubMed  Article  Google Scholar 

  10. 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):418–23.

    CAS  PubMed Central  PubMed  Article  Google Scholar 

  11. Jaenen N, Baudouin C, Pouliquen P, et al. Ocular symptoms and signs with preserved and preservative-free glaucoma medications. Eur J Ophthalmol. 2007;17(3):341–9.

    CAS  PubMed  Google Scholar 

  12. Anwar Z, Wellik SR, Galora A. Glaucoma therapy and ocular surface disease: current literature and recommendations. Curr Opin Ophthalmol. 2013;24(2):136–43.

    PubMed  Article  Google Scholar 

  13. Spectrum Thea Pharmaceuticals, Ltd. Monoprost 50 micrograms/ml eyedrops in a single-dose container: UK summary of product characteristics. http://www.medicines.org.uk/emc/medicine/27436/SPC/MONOPROST+latanoprost+50+mcg+ml+eye+drops%2c+solution+in+single-dose+container. Accessed 6 May 2014.

  14. Alm A, Nilsson SF. Uveoscleral outflow—a review. Exp Eye Res. 2009;88(4):760–8.

    CAS  PubMed  Article  Google Scholar 

  15. Liang H, Pauly A, Riancho L, et al. Toxicological evaluation of preservative-containing and preservative-free topical prostaglandin analogues on a three-dimensional-reconstituted corneal epithelium system. Br J Ophthalmol. 2011;95(6):869–75.

    PubMed Central  PubMed  Article  Google Scholar 

  16. Pauly A, Roubeix C, Liang H, et al. In vitro and in vivo comparative toxicological study of a new preservative-free latanoprost formulation. Invest Ophthalmol Vis Sci. 2012;53(13):8172–80.

    CAS  PubMed  Article  Google Scholar 

  17. Inoue K, Shiokawa M, Wakakura M, et al. Deepening of the upper eyelid sulcus caused by 5 types of prostaglandin analogs. J Glaucoma. 2013;22(8):626–31.

    PubMed  Article  Google Scholar 

  18. Sakata R, Shirato S, Miyata K, et al. Recovery from deepening of the upper eyelid sulcus after switching from bimatoprost to latanoprost. Jpn J Ophthalmol. 2013;57(2):179–84.

    PubMed  Article  Google Scholar 

  19. Aihara M, Shirato S, Sakata R. Incidence of deepening of the upper eyelid sulcus after switching from latanoprost to bimatoprost. Jpn J Ophthalmol. 2011;55(6):600–4.

    PubMed  Article  Google Scholar 

  20. Hariharan S, Minocha M, Mishra GP, et al. Interaction of ocular hypotensive agents (PGF2 analogs - bimatoprost, latanoprost, and travoprost) with MDR efflux pumps on the rabbit cornea. J Ocul Pharmacol Ther. 2009;25(6):487–97.

    CAS  PubMed Central  PubMed  Article  Google Scholar 

  21. Sjoquist B, Stjernschantz J. Ocular and systemic pharmacokinetics of latanoprost in humans. Surv Ophthalmol. 2002;47(Suppl 1):S6–12.

    PubMed  Article  Google Scholar 

  22. Rouland J-F, Traverso CE, Stalmans I, et al. Efficacy and safety of preservative-free latanoprost eyedrops, compared with BAK-preserved latanoprost in patients with ocular hypertension or glaucoma. Br J Ophthalmol. 2013;97(2):196–200.

    PubMed  Article  Google Scholar 

  23. Cucherat M, Stalmans I, Rouland JF. Relative efficacy and safety of preservative-free latanoprost (T2345) for the treatment of open-angle glaucoma and ocular hypertension: an adjusted indirect comparison meta-analysis of randomized clinical trials. J Glaucoma. 2013;. doi:10.1097/IJG.0b013e3182a075e6.

    Google Scholar 

  24. PRISMA, transparent reporting of systematic reviews and meta-analyses. The PRISMA statement. http://prisma-statement.org/statement.htm. Accessed 16 Apr 2014.

  25. Bucher HC, Guyatt GH, Griffith LE, et al. The results of direct and indirect treatment comparisons in meta-analyses of randomized, controlled trials. J Clin Epidemiol. 1997;50(6):683–91.

    CAS  PubMed  Article  Google Scholar 

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Disclosure

The preparation of this review was not supported by any external funding. During the peer review process, the manufacturer of the agent under review was offered an opportunity to comment on this article. Changes resulting from comments received were made by the author on the basis of scientific and editorial merit. Mark Sanford is a salaried employee of Adis/Springer.

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  1. Adis, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, North Shore, 0754, Auckland, New Zealand

    Mark Sanford

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  1. Mark Sanford
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Correspondence to Mark Sanford.

Additional information

The manuscript was reviewed by: Y. Catoira-Boyle, Department of Ophthalmology, Eugene and Marilyn Glick Eye Institute, Indiana University School of Medicine, Indianapolis, IN, USA; C.A.B. Webers, Department of Ophthalmology, Maastricht University Medical Center, Maastricht, The Netherlands.

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Sanford, M. Preservative-Free Latanoprost Eye Drops in Patients with Primary Open-Angle Glaucoma/Ocular Hypertension. Clin Drug Investig 34, 521–528 (2014). https://doi.org/10.1007/s40261-014-0203-4

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  • DOI: https://doi.org/10.1007/s40261-014-0203-4

Keywords

  • Glaucoma
  • Latanoprost
  • Bimatoprost
  • Benzalkonium Chloride
  • Travoprost