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Open-angle glaucoma: Poor data for the fixed combination tafluprost/timolol

Date:
April 7, 2015
Source:
Institute for Quality and Efficiency in Health Care
Summary:
Research that focused on open-angle glaucoma provided study results that are uncertain, claiming that information on important outcomes is lacking. As such, no added benefit can be determined for the fixed combination of tafluprost and timolol.
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The fixed combination of the drugs tafluprost and timolol (trade name: Taptiqom) has been approved in Germany since December 2014 for adults with open-angle glaucoma or increased intraocular pressure (ocular hypertension). The combination therapy is indicated in patients who are insufficiently responsive to topical monotherapy with beta-blockers or prostaglandin analogues, and who would benefit from preservative-free eye drops.

The German Institute for Quality and Efficiency in Health Care (IQWiG) examined in a dossier assessment whether this drug combination offers an added benefit over the appropriate comparator therapy. However, such an added benefit cannot be derived from the dossier, as the study results are very uncertain and evaluable data on important outcomes are lacking.

Incomplete information on patient groups

In its dossier, the drug manufacturer chose the non-fixed combination of a beta-blocker (timolol) plus a prostaglandin analogue (tafluprost) as the appropriate comparator therapy. For the comparison with the fixed combination, the manufacturer presented a randomized controlled trial including not only patients pretreated with prostaglandin analogues or beta-blockers, but also treatment-naive patients.

The study results are very uncertain for several reasons: For instance, it is unclear how high the actual proportion of relevant study participants is who received prior monotherapy (prostaglandin analogues or beta-blockers). In addition, patient characteristics and subgroup analyses are lacking for patients pretreated with prostaglandin analogue monotherapy, and no information at all is available on patients pretreated with beta-blocker monotherapy.

In summary, neither positive nor negative effects were determined

In the manufacturer dossier, evaluable data are lacking for important outcomes such as blind spots in the visual field (scotoma), diseases of the ocular surface, improvement or deterioration in visual acuity, and health-related quality of life.

No statistically significant differences between treatment groups were shown with regard to side effects.

Overall, neither positive nor negative effects can be determined for the fixed combination of tafluprost and timolol compared with the non-fixed combination. No added benefit can therefore be derived.


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Cite This Page:

Institute for Quality and Efficiency in Health Care. "Open-angle glaucoma: Poor data for the fixed combination tafluprost/timolol." ScienceDaily. ScienceDaily, 7 April 2015. <www.sciencedaily.com/releases/2015/04/150407124227.htm>.
Institute for Quality and Efficiency in Health Care. (2015, April 7). Open-angle glaucoma: Poor data for the fixed combination tafluprost/timolol. ScienceDaily. Retrieved May 28, 2017 from www.sciencedaily.com/releases/2015/04/150407124227.htm
Institute for Quality and Efficiency in Health Care. "Open-angle glaucoma: Poor data for the fixed combination tafluprost/timolol." ScienceDaily. www.sciencedaily.com/releases/2015/04/150407124227.htm (accessed May 28, 2017).

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