Tafluprost 15micrograms/ml / Timolol 5mg/ml eye drops 0.3ml unit dose preservative free

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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Purpose: This review aims to consolidate and evaluate the clinical evidence on the efficacy and safety of benzalkonium chloride (BAK)-preserved and BAK-free latanoprost in the treatment of primary open-angle glaucoma (POAG) and ocular hypertension (OHT). The primary research question addresses whether BAK-free formulations offer comparable efficacy with improved safety profiles compared to BAK-preserved formulations. Methods: An extensive literature search was conducted using PubMed up to February 2025. Keywords included "latanoprost", "primary open-angle glaucoma", "ocular hypertension", "efficacy", and "safety". Inclusion criteria were peer-reviewed clinical trials and meta-analyses comparing latanoprost with placebo or other treatments (eg. bimatoprost, travoprost, tafluprost, latanoprostene bunod). Exclusion criteria included observational studies, review articles, and studies comparing preservative-free prostaglandin analogues and omidenepag. Results: Thirty-two studies (17 randomized clinical trials and 7 meta-analyses) were reviewed. Latanoprost, the first FDA-approved prostaglandin analogue, primarily increases uveoscleral outflow. Comparative studies indicate that latanoprost achieves a good balance between IOP reduction and tolerability compared to bimatoprost, travoprost, tafluprost, and unoprostone. Latanoprost also reduces visual field progression and maintains central corneal thickness (CCT). It improves ocular perfusion pressure (OPP), reducing the risk of glaucomatous optic neuropathy. Safety profiles show fewer side effects, such as conjunctival hyperemia, hypertrichosis, and periocular pigmentation, compared to other PGAs. BAK-free formulations demonstrate improved corneal health and patient compliance due to reduced ocular surface toxicity. Conclusion: Latanoprost remains a first-line therapy for POAG and OHT due to its efficacy, safety, and patient adherence. The availability of BAK-free formulations enhances its therapeutic profile, with reduced corneal toxicity making it a preferred choice for long-term glaucoma management.

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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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Purpose: The effectiveness, safety and tolerability of the preservative-free fixed combination of tafluprost and timolol (PF-TTFC) were evaluated over the 24-h in patients with open-angle glaucoma or ocular hypertension showing signs and symptoms of Ocular Surface Disease (OSD) and uncontrolled intraocular pressure (IOP) on prior benzalkonium chloride (BAK) - Latanoprost monotherapy. Methods: In this multi-center, prospective, interventional, non-comparative clinical trial, patients treated with BAK-Latanoprost underwent 24-h IOP measurements (8 am, 11 am, 2 pm, 5 pm, 8 pm, 11 pm, 2 am, 5 am) at baseline and after 3 months from switch to PF-TTFC. Mean 24-h IOP and daytime (8 am-8 pm) vs nighttime (11 pm - 5 am) IOP were compared. Changes in OSD signs and symptoms, quality of life (QoL) and in-vivo corneal confocal microscopy (IVCM) were also evaluated. Results: Thirty-eight patients were analyzed. The mean 24-h IOP significantly decreased after 3 months from 17.8 mmHg (95% CI: 17.1-18.6) to 15.3 mmHg (95% CI: 14.6-16.1, p < 0.001). IOP was significantly reduced both at daytime (p < 0.001) and nighttime (p < 0.001), with better IOP control at night [-2.9 (95% CI: -3.5 to -2.1) mmHg vs -2.3 (95% CI: -2.9 to -1.6) mmHg]. In 20 patients (52.6%), corneal fluorescein staining improved, whereas in 4 patients (10.5%) it worsened. Hyperemia has improved in 24 (63.3%) patients and worsened in 2 (5.3%). Breakup time, Schirmer test and QoL scores showed no changes. At IVCM, the mean corneal wing-cell size was found significantly decreased (p < 0.005). Conclusion: The switch from BAK-Latanoprost to PF-TTFC significantly reduced IOP over the 24-h and improved OSD signs and symptoms.

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BACKGROUND/AIMS: To compare the efficacy and safety of a new preservative-free bimatoprost 0.01%/timolol 0.1% fixed combination (BTFC) eye gel with those of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (BTFC eye drops) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). METHODS: In this phase III, international, multi-centre, randomised, parallel group, investigator-masked study, patients receiving a first-line monotherapy, having insufficiently controlled intraocular pressure (IOP) and requiring dual therapy were randomised to receive either BTFC eye gel or BTFC eye drops once daily for 12 weeks. The primary efficacy endpoint was the change in IOP from baseline to week 12 at 08:00 in the assessed eye. Further efficacy and safety endpoints were assessed as secondary outcomes. RESULTS: The mean±SD change in IOP from baseline to week 12 at 08:00 was -10.96±3.43 mmHg for the BTFC eye gel group and -11.14±3.56 mmHg for the BTFC eye drop group. The least-squares mean difference (BTFC eye gel minus BTFC eye drops) was -0.04±0.24 mmHg (95% CI -0.51 to 0.43 mmHg), with the upper bound of the 95% CI lower than the predefined margin of +1.5 mmHg at week 12 at 08:00. Similar IOP-lowering efficacy was demonstrated at all other timepoints. The safety profile was comparable between the treatment groups. No patients in the BTFC eye gel group discontinued the study due to a treatment-related adverse event compared with 8 (2.9%) patients in the BTFC eye drop group. CONCLUSION: Low-concentration BTFC eye gel can be considered as a safe and effective treatment in the therapeutic management of glaucoma and OHT.

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Objective The objective of this study is to evaluate the effectiveness, safety, and tolerability of a preservative-free fixed-dose combination of tafluprost (0.0015%) and timolol (0.5%) (PF tafluprost/timolol FC) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). Methodology This real-world, prospective, noninterventional study was conducted in Taiwanese patients with OAG or OHT who had an inadequate response or intolerance to topical prostaglandin analogue (PGA) monotherapy and were therefore switched to PF tafluprost/timolol FC. The primary endpoint was the mean change in intraocular pressure (IOP) from baseline to six months after initiating treatment. Changes in clinical signs and subjective symptoms were also evaluated, and adverse events (AEs) were recorded. Results A total of 49 patients were enrolled, and 42 completed the study. The mean ± SD IOP at baseline was 16.5 ± 3.5 mmHg, which significantly decreased to 15.4 ± 3.4 mmHg at six months (absolute reduction: 1.1 ± 2.6 mmHg; p < 0.001). The number of patients with a tear break-up time >10 seconds increased significantly from three (7.5%) at baseline to 22 (52.5%) at six months (p < 0.001). However, a nonsignificant increase was observed in subjective symptoms. Six treatment-related AEs were reported, all of which were nonserious and mild to moderate in severity, including contact dermatitis, redness and itchiness, and blurred vision. Conclusions This real-world, prospective study in Taiwan demonstrated that switching patients with OAG or OHT from PGA monotherapy to PF tafluprost/timolol FC was effective and safe for reducing IOP.

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