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Prospective Observational Post-Marketing Study of Tafluprost for Glaucoma and Ocular Hypertension: Short-Term Efficacy and Safety

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Abstract

Introduction

This study investigated the intraocular pressure (IOP)-lowering effects and safety of tafluprost ophthalmic solution 0.0015% in actual clinical practice.

Methods

We started a mandatory prospective 2-year observational study, which collected IOP, conjunctival hyperemia score, corneal staining score, and adverse event data from glaucoma and ocular hypertension (OH) patients not previously treated with tafluprost at 2, 12, and 24 months. This report analyzes the 2-month findings.

Results

Of the 4,180 patients from 553 medical institutions in Japan, most patients had primary open-angle glaucoma (POAG, 38.1%) or normal-tension glaucoma (NTG, 44.2%). After 2 months of tafluprost administration, IOP was significantly reduced by 4.3 ± 5.2 mmHg in POAG, 2.4 ± 2.5 mmHg in NTG, 3.6 ± 5.3 mmHg in primary angle-closure glaucoma, 5.6 ± 7.1 mmHg in other types of glaucoma, and 5.3 ± 4.8 mmHg in OH. IOP was significantly reduced by 4.3 ± 4.0 mmHg in the naïve monotherapy group, 1.9 ± 3.5 mmHg in switching from prior treatment, and 3.7 ± 4.1 mmHg in the add-on therapy group. Among patients switched, the prostaglandin analog (PGA) latanoprost was the previous predominant drug (57.4%), followed by travoprost (13.8%). Significant IOP reductions were observed by 1.5 ± 3.4 mmHg in switching from latanoprost and 1.3 ± 3.7 mmHg in switching from travoprost. The conjunctival hyperemia score peaked at 1 month in the naïve monotherapy and add-on therapy groups, whereas it was significantly decreased in patients switched from another PGA. The corneal staining score showed no particular changes. Incidence of adverse drug reaction (ADR) was 7.70 % (322/4,180 patients), and all major ADRs involved the eyes or skin around the eyes.

Conclusion

Tafluprost showed significant IOP-lowering effects without any safety concerns in patients with various types of glaucoma and OH in daily clinical practice and tafluprost is highly effective in any therapeutic patterns.

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Acknowledgments

All named authors meet the ICMJE criteria for authorship for this manuscript, take responsibility for the integrity of the work as a whole, and have given final approval for the version to be published. We wish to express our gratitude to the physicians at the medical institutions who cooperated in the study. Sponsorship and article processing charges for this study were funded by Santen Pharmaceutical Co., Ltd., Osaka, Japan. English language editing and manuscript preparation for submission for this study were provided by James Eudeikis, Forte Science Communications (Tokyo, Japan) and Hiromi Okubo, Springer Japan (Tokyo, Japan). This support was funded by Santen Pharmaceutical Co. Ltd. (Osaka, Japan).

Conflict of interest

Yasuaki Kuwayama is affiliated with Fukushima Eye Clinic, and has received consulting fees from Bausch & Lomb Japan, Kowa Pharmaceutical, Pfizer Japan, Santen Pharmaceutical and Senju Pharmaceutical, and honoraria from Alcon Japan, MSD and Otsuka Pharmaceutical. Akio Nomura is an employee of Santen Pharmaceutical Co., Ltd.

Compliance with ethics guidelines

This current on-going post-marketing, multicenter, prospective, non-interventional, observational study is being conducted in accordance with the requirements of the regulatory authority in Japan, the Good Post-Marketing Study Practice (MHLW Ordinance No. 171; December 20, 2004). The study began in December 2008 and is scheduled to run through December 2014. Since the research protocol was reviewed and approved by the regulatory authority in Japan prior to beginning the study, approval by the ethics review committees at each participating medical institution is not required. The Japanese regulatory authority does not require informed consent for post-marketing observational studies; this study did not obtain informed consent from the patients.

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Authors and Affiliations

  1. Fukushima Eye Clinic, Fukushima-ku, Osaka, Japan

    Yasuaki Kuwayama

  2. Santen Pharmaceutical Co., Ltd, Osaka, Japan

    Akio Nomura

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  1. Yasuaki Kuwayama
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  2. Akio Nomura
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Corresponding author

Correspondence to Yasuaki Kuwayama.

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Kuwayama, Y., Nomura, A. Prospective Observational Post-Marketing Study of Tafluprost for Glaucoma and Ocular Hypertension: Short-Term Efficacy and Safety. Adv Ther 31, 461–471 (2014). https://doi.org/10.1007/s12325-014-0109-9

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  • DOI: https://doi.org/10.1007/s12325-014-0109-9

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