Preservative-free fixed combination of tafluprost 0.0015% and timolol 0.5% in patients with open-angle glaucoma and ocular hypertension: results of an open-label observational study

Abstract

BackgroundEfficacy, tolerability and safety of the novel preservative-free fixed combination of tafluprost 0.0015%/timolol 0.5% (Taptiqom®) were investigated in an observational study in Germany.ObjectiveTo assess efficacy, tolerability and safety of the preservative-free fixed combination of tafluprost 0.0015%/timolol 0.5% in a real-life setting.MethodsIntraocular pressure (IOP) was recorded for each eye at baseline (any previous therapy or untreated) and 4–16 weeks after changing medical treatment to or initiating treatment with the preservative-free fixed combination of tafluprost 0.0015%/timolol 0.5%. Change in IOP was evaluated over the study period for all patients and for specific pretreatment subgroups. Clinical signs such as conjunctival hyperemia and lid-parallel conjunctival folds (LIPCOF) were recorded using standardized comparative photographs. Corneal staining, subjective symptoms and local comfort were measured using a four-step scale. All adverse events were recorded.ResultsAmong 1,157 patients enrolled, 1,075 patients were treated with the preservative-free fixed combination as the only medication at the final visit. Medical treatment was initiated in 741 patients because of an insufficient IOP-lowering effect of the prior medication. In 343 patients, medication was changed because of tolerability issues. The preservative-free fixed combination lowered IOP significantly in the subgroup of naïve patients, all subgroups with prior monotherapy and patients with prior fixed combinations: naïve patients: −8.9 mmHg, alpha- 2-agonists: −6.4 mmHg, beta-blockers: −5.7 mmHg, carbonic anhydrase inhibitors: −5.2 mmHg, prostaglandins: −4.7 mmHg, fixed-combination prostaglandins/timolol: −2.4 mmHg. At the final visit, clinical signs and subjective symptoms were improved in patients with prior medical therapy. Local comfort was rated as “very good” or “good” by 89.1% of patients at the final visit. Only few adverse events occurred during the treatment period.ConclusionThe preservative-free fixed combination of tafluprost 0.0015%/timolol 0.5% was effective, well tolerated and showed a good safety profile.

Switching to Preservative-Free Tafluprost/Timolol Fixed-Dose Combination in the Treatment of Open-Angle Glaucoma or Ocular Hypertension: Subanalysis of Data from the VISIONARY Study According to Baseline Monotherapy Treatment

“…Regardless of the prior monotherapy subgroup, statistically and clinically significant IOP reductions were present from Week 4 and sustained over the 6-month study period. These data are reflective of the primary VISIONARY publication and of other real-world data concerning IOP-lowering efficacy with PF tafluprost/timolol FC following a switch away from different topical glaucoma medications [ 22 , 23 ]. Emerging country-level data from the VISIONARY study has revealed differences in baseline IOP, with clinicians in some countries selecting patients with higher IOPs for inclusion in the study [ 31 – 34 ].…”

Efficacy and Safety of Switching from Tafluprost to a Tafluprost/Timolol Fixed Combination in Patients With Primary Open-Angle Glaucoma

“…Again, there was no significant difference between our findings and those of the above-mentioned studies [ 5 , 6 ]. However, the previous studies that investigated in patients with glaucoma and OH reported that the width and rate of IOP reduction were 3.6–5.1 mmHg and 18.0–24.0% during 4–16 weeks of follow-up [ 7 ] and 2.5 mmHg and 15.0% during 3 months of follow-up [ 8 ].…”

“…TTFC has demonstrated efficacy and safety in reducing IOP in some studies [ 5 - 11 ]. However, with the exception of some studies in Japan [ 5 , 6 , 8 ] and one study in Germany [ 7 ], direct comparisons of switching from tafluprost to TTFC are limited. The efficacy and safety of TTFC have been investigated in patients with all types of glaucoma and Ocular Hypertension (OH) [ 7 , 8 ], but there are no reports on the efficacy and safety of TTFC in Japanese patients with primary open-angle glaucoma (POAG).…”

“…However, with the exception of some studies in Japan [ 5 , 6 , 8 ] and one study in Germany [ 7 ], direct comparisons of switching from tafluprost to TTFC are limited. The efficacy and safety of TTFC have been investigated in patients with all types of glaucoma and Ocular Hypertension (OH) [ 7 , 8 ], but there are no reports on the efficacy and safety of TTFC in Japanese patients with primary open-angle glaucoma (POAG). Furthermore, the previous studies of TTFC in Japan [ 5 , 6 ] were conducted as clinical trials, and there have been no direct comparisons of the efficacy and safety of tafluprost and TTFC in patients with POAG and OH in routine clinical practice.…”

Terapi Pseudoexfoliation Glaucoma

“…7 Suatu studi observasional juga menunjukkan hasil serupa yaitu kombinasi tanpa pengawet terfiksir dari tafluprost 0,0015% dan timolol 0,5% sangat efektif dan aman bagi pasien glaukoma sudut terbuka. 21 Kedua, bimatoprost yang diadministrasi QOD-HS lebih efektif untuk mengontrol TIO pada pasien PEG yang memiliki masalah efek samping dengan bimatoprost 0,03% QHS. Belum ada studi lain dengan topik serupa untuk dilakukan komparasi.…”