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Drug Safety Evaluation

Safety and tolerability of the tafluprost/timolol fixed combination for the treatment of glaucoma

, MD PhD DSc & , MD PhD
 

Abstract

Introduction: The preservative-free (PF) fixed combination (FC) of tafluprost 0.0015%/timolol 0.5% is the newest member of the prostaglandin analogue/timolol FC class.

Areas covered: In this review, we summarize data on safety and tolerability of this FC.

Expert opinion: The intraocular pressure-lowering effect of the tafluprost/timolol FC is approximately 30 – 35%, which is similar to that of the other members of the class. However, in contrast to most similar eye drops the tafluprost/timolol FC is manufactured in a PF, unit-dose pipette formulation. The PF nature eliminates preservative-related ocular surface changes, and improves tolerability. In clinical studies, the tafluprost/timolol FC was well tolerated. The side effects represented the typical side effects of the topical prostaglandin analogue class. The most common side effect, conjunctival hyperemia was mild, and occurred in only 6.4 – 8% of patients during 6 months of treatment. The figures for ocular irritation were also low (7.0 – 12.7%). The other side effects occurred only in very few patients. The frequency and severity of conjunctival hyperemia was lower than those published for most prostaglandin/timolol FCs. Thus, the main clinical advantage of this PF FC is improved tolerability, which may support treatment adherence of glaucoma patients.

Declaration of interest

G Holló is a consultant of Alcon, Inc. and Santen Oy. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending or royalties. A Katsanos declares no commercial relationship.

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