A multicenter, real-world, observational study showed safety and efficacy of a fixed-dose combination of preservative-free tafluprost and timolol in clinical practice. Patients who did not sufficiently respond to previous therapies achieved significant IOP reduction at 6 months, with the added benefit of decreased ocular surface side effects.
The VISIONARY study included 577 patients with open-angle glaucoma or ocular hypertension who did not respond or were not tolerant to monotherapy with beta-blockers or prostaglandin analogues. Patients were switched to single daily administration of the preservative-free tafluprost/timolol combination. Sixty-six centers across Europe participated in the study.
The treatment had a high response rate, with 70% of responders having a more than 20% IOP reduction at 6 months. Mean IOP reduction from baseline was 5.7 mm Hg (24%) and was significant at all study visits. Full reduction was achieved at week 4 and maintained over 6 months.
The preservative-free formulation had a positive impact on the reduction of corneal fluorescein staining score, conjunctival hyperemia, dry eye severity, irritation, itching and foreign body sensation. Tolerability was rated as good or very good by 88% of the patients at week 4, progressively increasing up to 91% at 6 months.
On the basis of clinical evaluation, 84.7% of investigators considered IOP better controlled with the treatment and reported overall better compliance. They also observed reduced ocular signs in 63% of patients.
The real-world setting of the study gave a good indication of how this option might work in everyday practice in patients with different types of glaucoma, with various degrees of ocular surface disease and without a washout period. The good results provided evidence in support of both fixed-dose combinations and preservative-free formulations.
“The VISIONARY study addresses two questions important in clinical glaucoma management: the usefulness of changing topical medication from a prostaglandin analogue or a beta receptor blocker monotherapy to the [fixed combination] tafluprost and timolol and the clinical benefits offered by the preservative-free formulation of this [fixed combination],” Gábor Hóllo, MD, PhD, DSc, one of the study authors, told Healio/OSN. “These results show that open-angle glaucoma and [ocular hypertension] patients considerably benefit from being switched to this new preservative-free fixed combination, both in terms of additional IOP reduction and improved medication tolerance.” – by Michela Cimberle
Disclosure: Hóllo reports he has received consultancy and lecturing fees from Santen and Novartis. Please see the study for all other authors’ relevant financial disclosures.