Holló Gábor, Katsanos Andreas
Semmelweis University, Department of Ophthalmology , Mária u. 39, 1085 Budapest , Hungary
Expert Opin Drug Saf. 2015 Apr;14(4):609-17. doi: 10.1517/14740338.2015.1010507. Epub 2015 Feb 2.
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.
In this review, we summarize data on safety and tolerability of this FC.
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.
0.0015%他氟前列素/0.5%噻吗洛尔的无防腐剂(PF)固定组合(FC)是前列腺素类似物/噻吗洛尔FC类的最新成员。
在本综述中,我们总结了该FC安全性和耐受性的数据。
他氟前列素/噻吗洛尔FC的降眼压效果约为30%-35%,与该类其他成员相似。然而,与大多数类似滴眼液不同的是,他氟前列素/噻吗洛尔FC采用PF单剂量滴管制剂生产。PF性质消除了与防腐剂相关的眼表变化,并提高了耐受性。在临床研究中,他氟前列素/噻吗洛尔FC耐受性良好。副作用表现为局部前列腺素类似物类的典型副作用。最常见的副作用结膜充血较轻,在6个月治疗期间仅6.4%-8%的患者中出现。眼部刺激的发生率也较低(7.0%-12.7%)。其他副作用仅在极少数患者中出现。结膜充血的频率和严重程度低于大多数前列腺素/噻吗洛尔FC报道的水平。因此,这种PF FC的主要临床优势是耐受性提高,这可能有助于青光眼患者坚持治疗。