Reviewing the evidence surrounding preservative-free tafluprost/timolol fixed-dose combination therapy in open-angle glaucoma and ocular hypertension management: a focus on efficacy, safety, and tolerability

Oddone, Francesco

doi:10.1080/14740338.2022.2135701

Cited by 2 publications

(2 citation statements)

References 57 publications

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“…The initiation of medical treatment was determined by a sole glaucoma specialist. Patients with contraindications (e.g., diagnosed with asthma or arrhythmia) were excluded in accordance with the summary of product characteristics for PF tafluprost/timolol FC [ 1 ].…”

Section: Methodsmentioning

confidence: 99%

“…The preservative-free (PF) fixed-dose combination (FC) of 0.0015% tafluprost and 0.5% timolol (PF tafluprost/timolol FC; Santen Oy, Tampere, Finland) has been accessible in Korea since 2020. It is primarily indicated for reducing intraocular pressure (IOP) in adult patients with open-angle glaucoma (OAG) or ocular hypertension (OHT) who exhibit insufficient responsiveness to topical monotherapy with beta-blockers or prostaglandin analogs (PGAs) [1]. Therefore, this combination therapy, PF tafluprost/timolol FC, is recommended for individuals in need of multiple IOP lowering medications and who would derive advantages from PF eye drops.…”

Section: Introductionmentioning

confidence: 99%

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

Rhee,

Kim,

2024

Korean J Ophthalmol

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Purpose: To assess efficacy, safety, and tolerability of the preservative-free (PF) fixed-dose combination (FC) of tafluprost 0.0015%/timolol 0.5% (PF tafluprost/timolol FC) in treatments-naive 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 6 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 years (range, 26.0–85.0 years); among them, 42 were female (39.3%). Mean IOP at baseline for all patients was 18.6 ± 4.3 mmHg. The mean IOP at 6 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 at baseline 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.

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Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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

Rhee,

Kim,

2024

Korean J Ophthalmol

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Evidence in Practice: A Review of Real-Life Studies and Clinical Experience with the Preservative-Free Tafluprost (0.0015%) and Timolol (0.5%) Fixed-Dose Combination

Hollo

2024

OPTH

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The preservative-free fixed-dose combination formulation of 0.0015% tafluprost and 0.5% timolol (PF tafluprost/timolol FC) is among the topical intraocular pressure (IOP)-lowering therapies commonly used second-line for the management of ocular hypertension (OHT) and open-angle glaucoma (OAG), according to recommended treatment pathways. A growing body of evidence has developed in recent years regarding efficacy, safety and tolerability outcomes with PF tafluprost/timolol FC in both randomized controlled trials (RCTs) and real-life studies. This review aims to summarize key evidence from published Phase IV trials and real-life studies to highlight those data that complement RCT findings and support implementation of evidence-informed clinical practice. Real-life efficacy and safety outcomes are discussed through the lens of common clinical scenarios that ophthalmologists may encounter in the management of OHT/OAG. Phase IV studies conducted to date have demonstrated that the majority of OHT/OAG patients insufficiently controlled on topical prostaglandin or beta-blocker monotherapy may achieve IOP reductions of ≥20% following a switch to PF tafluprost/timolol FC therapy. Statistically significant IOP reductions were reported from 4 weeks and maintained through 6 months. Real-life studies and case series data also indicated that patients with poor IOP control on maximal/complex topical regimens benefited from a step down to PF tafluprost/timolol FC therapy, achieving significant and sustained IOP reductions. A number of studies have shown improvements in tolerability and the signs and symptoms of ocular health with PF tafluprost/timolol FC therapy, both in patients stepping up from monotherapy and in those simplifying their topical regimen. Clinicians reported better treatment adherence with PF tafluprost/timolol FC compared with prior treatments, which may have been associated with enhanced patient experience regarding treatment tolerability and is likely to have contributed to the long-term IOP-lowering efficacy outcomes observed. Real-life safety data for PF tafluprost/timolol FC reflect outcomes reported in published RCTs.

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Reviewing the evidence surrounding preservative-free tafluprost/timolol fixed-dose combination therapy in open-angle glaucoma and ocular hypertension management: a focus on efficacy, safety, and tolerability

Cited by 2 publications

References 57 publications

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

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

Evidence in Practice: A Review of Real-Life Studies and Clinical Experience with the Preservative-Free Tafluprost (0.0015%) and Timolol (0.5%) Fixed-Dose Combination

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