Patients treated with topical preservative-free tafluprost and timolol fixed-dose combination experienced a statistically and clinically significant IOP reduction, according to preliminary results of Santen’s real-world evidence VISIONARY study at the European Society of Ophthalmology congress.
The recently completed noninterventional European prospective study evaluated the effectiveness, tolerability and safety of topical preservative-free tafluprost 0.0015% and timolol 0.5% fixed-dose combination treatment in adults with open-angle glaucoma and ocular hypertension, according to a Santen press release. All patients demonstrated an insufficient response to previous monotherapy treatment with topical beta-blockers or prostaglandin analogues.
The treatment demonstrated statistically and clinically significant IOP reduction in 161 patients at both 4 and 12 weeks after initiation. The cohort experienced a mean IOP reduction from baseline of 5.32 mm Hg at week 4 and 5.73 mm Hg at week 12 (both P < .001). At week 12, 71.4% of 161 patients experienced an IOP reduction from baseline of 20% or more (P < .0001).
Conjunctival hyperemia decreased in 43.6% of 149 patients at week 12 (P < .001). Additionally, 34.6% of 130 patients experienced overall improvement in dry eye-related symptoms (P < .001), 34.1% of 129 patients reported overall improvement in irritation (P < .001), and 31.8% of 129 patients reported overall improvement in foreign body sensation (P = .005). Corneal fluorescein staining was reduced in 49.2% of 63 patients at week 12 (P < .0001), according to the release.
Eighty-seven percent of patients rated tolerability as good or very good.
Full study results will be submitted later this year.