Adjunctive use of tafluprost with timolol provides additive effects for reduction in intraocular pressure in patients with glaucoma

Purpose: Beta-blockers and prostanoid F2α (PF2α) analogues reduce intraocular pressure (IOP) by complementary mechanisms. A combination of treatments with additive effects may be beneficial to further reduce IOP in patients not sufficiently controlled with a single agent. This study aimed to investigate the efficacy and safety of tafluprost, a new PF2α derivative in development, as adjunctive therapy to timolol. Methods: In this multi-national, multi-centre, parallel-group, double-masked, phase III study, 185 patients with open-angle glaucoma or ocular hypertension and with IOP between 22-30 mmHg on timolol, were randomised to tafluprost 0.0015% eye drops (n=96) or vehicle (n=89) as adjunctive therapy with timolol 0.5% eye drops for 6 weeks. The primary endpoint was change from baseline in the overall diurnal IOP at 6 weeks. Safety parameters were also analysed. Results: At week 6, the additional effect of tafluprost, as compared to timolol baseline, was between 22-24%. This additional effect was consistently larger than in the vehicle group. There were more ocular events, including conjunctival redness, iris colour and eyelash changes with tafluprost compared with the vehicle (overall 42% vs 29%), but most were mild in severity. Conclusions: Tafluprost, when administered as adjunctive therapy to timolol, is effective and well tolerated for the treatment of glaucoma and ocular hypertension.