Tafluprost / Timolol (1) – Taptiqom®

• Clinical trials
  • This was a randomised, active-controlled, double-blind, multicentre trial in which the preservative-free fixed-dose combination of tafluprost and timolol (hereinafter: tafluprost/timolol) was compared with the preservative-free separate combination of the two individual active substances, tafluprost and timolol (hereinafter: tafluprost + timolol).

a) Reduction of intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension who respond inadequately to topical monotherapy with beta-blockers or prostaglandin analogues and require combination therapy, and who benefit from preservative-free eye drops

• For patients with open-angle glaucoma or ocular hypertension who respond inadequately to topical monotherapy with beta-blockers or prostaglandin analogues and require combination therapy, and who benefit from preservative-free eye drops to lower intraocular pressure (IOP), an additional benefit is not proven.
• In light of these considerations, based on the information in the dossier and the IQWiG’s benefit assessment, the statements and the IQWiG’s addendum to the benefit assessment, the G-BA concludes that the additional benefit of tafluprost/timolol over the appropriate comparator therapy is not proven.
• mortality
  • No data on deaths are available for the study; therefore, the additional benefit for this endpoint is not proven.
• morbidity
  • The endpoint ‘ocular surface disease’ is a composite endpoint; it remains unclear whether the findings for the individual components are associated with symptoms (e.g. results of biomicroscopic examination of the eye) and are therefore patient-relevant. Consequently, the data presented for this endpoint are not usable, and additional benefit is deemed not proven.
  • For the endpoints ‘improvement’ or ‘deterioration’ in visual acuity and the endpoint ‘visual field loss’, no analyses are available for the relevant patient population (previously treated patients on prostaglandin analogue monotherapy). An additional benefit is therefore not proven in each case.
• Health-related quality of life
  • Health-related quality of life was not investigated in the study; an additional benefit is therefore not proven.
• Side effects
  • For the endpoints of serious adverse events (SAEs) and ocular AEs, there was no statistically significant difference between the two treatment groups. Discontinuations due to AEs (and thus also discontinuations due to ocular AEs) or ocular SAEs did not occur. There is no hint that tafluprost/timolol causes greater or minor harm than tafluprost + timolol; greater or minor harm is therefore not proven for any of the above-mentioned endpoints.
• Conclusion
  • Based on the available data, there is no proof of additional benefit from tafluprost/timolol (fixed-dose combination) compared with tafluprost + timolol (open combination). The study compared only preservative-free formulations as fixed-dose versus open combinations. An additional benefit due to the absence of preservatives cannot therefore be assessed on the basis of the available study. A potential additional benefit of the fixed-dose combination, which requires a lower frequency of instillation and a smaller volume of drops compared with the open-label combination, was not considered in the study; possible effects on quality of life were not assessed.

Courtesy translation only, please refer to the German original.