IOP-lowering efficacy and tolerability of preservative-free tafluprost 0.0015% among patients with ocular hypertension or glaucoma

Abstract

Objective:

Tafluprost, the first preservative-free prostaglandin analogue for topical ophthalmic use to lower IOP, was introduced in Germany in 2008. After the approval for ophthalmic use, an open-label, multicentre, observational study was conducted between October 2008 and April 2009. Major objectives of this study were to evaluate the real world efficacy, local tolerability and safety of this first in class preservative-free prostaglandin preparation in patients with ocular hypertension and glaucoma.

Methods:

A total of 544 patients were treated with the preservative-free formulation of tafluprost 0.0015%. The majority of these patients had poor IOP control and/or poor local tolerance of their medication prior change of medication. The decision to change the previous therapy or to initiate treatment was made solely by the participating ophthalmologists. IOP readings were recorded at baseline before changing medication or initiating treatment in newly diagnosed patients, 4–6 weeks and 12 weeks after change of medication or initiation of treatment with preservative-free tafluprost. In addition, patient demographics, subjective symptoms (i.e. burning, foreign body sensation, itching and stinging) and objective clinical signs such as conjunctival hyperaemia were collected. Subjective symptoms were evaluated using a 4 point scale ranging from ‘no symptoms’, ‘mild symptoms’, ‘moderate symptoms’ to ‘severe symptoms’. As a clinical sign severity of conjunctival hyperaemia was evaluated. All adverse events were collected.

Results:

Three hundred and sixty patients were switched from monotherapy, 45 patients were naïve to treatment. A total of 139 patients were treated with fixed or non-fixed combinations prior to changing medication. In these patients preservative-free tafluprost was used either as a substitution for the fixed or non-fixed combination, as an add-on to the existing combination therapy or as one agent in a newly initiated treatment regimen. Preservative-free tafluprost provided an IOP decrease in most pre-treatment subgroups, with an overall reduction of IOP in all patients (N = 544) from 19.4 ± 5.0 mmHg at baseline to 15.7 ± 4.1 mmHg after 4 to 6 weeks and to 15.3 ± 3.5 mmHg after 12 weeks. Both values were significantly lower than treated baseline IOP (p < 0.001). An IOP of ≤18 mmHg was achieved in 79.5% of eyes treated with the preservative-free formulation of tafluprost 12 weeks after changing medication. Both subjective symptoms and objective clinical signs improved after changing medication. Only a few adverse events occurred during the follow-up period.

Conclusions:

Although this study was limited by its observational design, the results demonstrate that preservative-free tafluprost is an effective, well tolerated, and safe medication in a patient population with poor IOP control and/or tolerability issues with their medication prior used.

Key words:

• Glaucoma
• Ocular hypertension
• Preservatives
• Prostaglandin
• Tafluprost

Transparency

Declaration of funding

This study was financially supported by Santen Oy, Tampere, Finland.

Declaration of financial/other relationships

A.H. has disclosed that he is a consultant to, and speaker for, Santen Oy. O.M.R. has disclosed that he has no financial or other significant relationships to Santen Oy. F.K. has disclosed that he is a consultant to Santen Oy. M.B. has disclosed that she is an employee of Santen GmbH Germany.

Some peer reviewers receive honoraria from CMRO for their review work. The peer reviewers of this paper have disclosed that they have no relevant financial relationships.

Acknowledgment

Medical writing, data management and statistical analysis of the present study were done by eyecons (F.K.) with financial support by Santen Oy.

Preliminary reports of these data were presented at the 107th congress of the German Ophthalmic Society, Sep 24–29, 2009, Leipzig, Germany and at the 8th International Symposium on Ocular Pharmacology and Therapeutics, December 3–6, 2009, Rome, Italy.

Notes

*Taflotan and Taflotan sine are registered trade names of Santen Oy, Tampere, Finland.

†Tapros is a registered tradename of Santen Pharmaceutical Co. Ltd, Osaka, Japan.

‡Saflutan is a registered trade name of Merck Sharp & Dohme Corp.