Preservative-Free Fixed Combination of Tafluprost 0.0015% and Timolol 0.5% for Treatment-Naive Patients with Open-Angle Glaucoma.

PURPOSE: To assess efficacy, safety, and tolerability of the preservative-free fixed-dose combination of tafluprost 0.0015%/timolol 0.5% (PF tafluprost/timolol FC) in treatments-naïve patients with primary open-angle glaucoma (POAG).

METHODS: This was a retrospective, real-world clinical practice setting study that included 107 eyes of 107 subjects with POAG who had never been treated for glaucoma. All subjects were received PF tafluprost/timolol FC once daily. Intraocular pressure (IOP) levels were documented for each eye at the untreated baseline and up to six months after the initiation of medical treatment. All adverse events, including ocular and systemic adverse reactions, were recorded. Additionally, the reasons for medication discontinuations were thoroughly documented.

RESULTS: A total of 32 POAG patients with high-baseline IOP (> 21 mmHg) and 75 with normal-baseline IOP were included in the study. The subjects' baseline mean age was 62.4 ± 8.7 (range: 26 - 85 years); among them, 42 were women (39.3%). Mean IOP at baseline for all patients was 18.6 ± 4.3 mmHg. The mean IOP at six months was 12.6 ± 4.7 mmHg, representing a significant decrease compared to the baseline (-32%; P< 0.001). In POAG patients with high-baseline IOP, mean IOP was significantly lowered from 28.0 ± 5.7 mmHg at baseline to 18.0 ± 5.5 mmHg (-35%; P< 0.001); in patients with normal-baseline IOP, from 14.6 ± 3.4 mmHg to 10.3 ± 4.1 mmHg (-29%; P< 0.001). PF tafluprost/timolol FC was well tolerated and safe. After 6 months, 97.2% of all patients remained on therapy.

CONCLUSIONS: In this real-world observational study, once-daily treatment with PF tafluprost/timolol FC demonstrated clinically relevant and statistically significant efficacy, as well as safety and good tolerability, in treatment-naive patients diagnosed with POAG.