Preservative-free latanoprost eye drops in patients with primary open-angle glaucoma/ocular hypertension.

Abstract

Latanoprost is an ester prodrug prostaglandin F2α analogue that is a selective agonist of endogenous prostanoid FP receptors and that reduces intraocular pressure (IOP) by increasing the uveoscleral outflow of aqueous humour. Preservative-free (PF) latanoprost [Monoprost(®)] is a new formulation of latanoprost that is approved for use in the EU in patients with primary open-angle glaucoma (POAG)/ocular hypertension. This article reviews the clinical pharmacology of this new formulation, focussing on its efficacy and tolerability in this indication. PF latanoprost was efficacious in reducing IOP in a randomized, investigator-masked, multinational trial in patients with POAG/ocular hypertension (n = 404). At days 15, 42 and 84 of follow-up, PF latanoprost was noninferior to benzalkonium chloride-preserved (BAK) latanoprost in terms of reductions in IOP. In this trial, at days 42 and 84 the proportions of patients with conjunctival hyperaemia were significantly lower with PF latanoprost than with BAK latanoprost. Patient subjective ratings of ocular symptoms were also significantly lower with PF latanoprost than with BAK latanoprost. In the absence of head-to-head comparisons with other anti-glaucoma drugs, an adjusted, indirect comparison meta-analysis was performed using data from 21 randomized clinical trials in patients with POAG/ocular hypertension. Based on this analysis, PF latanoprost had similar efficacy to different formulations of three comparator prostaglandin analogues in reducing the patient's IOP and was associated with a significantly lower risk of developing hyperaemia/ocular redness than these comparators. PF latanoprost offers a useful alternative to the available preserved prostaglandin analogues for the treatment of POAG/ocular hypertension.