Preservative-free bimatoprost 0.03%/timolol 0.5% fixed combination in patients with glaucoma in clinical practice

Stefan Pfennigsdorf, Peter Eschstruth, Stefan Häsemeyer, Cord Feuerhake, Gerrett Brief, Ioana Grobeiu, Andrew Shirlaw, Stefan Pfennigsdorf, Peter Eschstruth, Stefan Häsemeyer, Cord Feuerhake, Gerrett Brief, Ioana Grobeiu, Andrew Shirlaw

Abstract

Purpose: The aim of this study was to evaluate the efficacy and tolerability of, and compliance to, preservative-free (PF), fixed-combination (FC) bimatoprost 0.03%/timolol 0.5% in patients with primary open-angle glaucoma or ocular hypertension in a clinical practice setting.

Patients and methods: This open-label study observed patients switched to PF FC bimatoprost 0.03%/timolol 0.5% due to insufficient intraocular pressure (IOP) control on previous therapies. IOP was measured at baseline and at ~12 weeks. Tolerability and continuation of therapy were also assessed.

Results: A total of 1,553 patients were included in the study, and the per-protocol population comprised 1,391 patients. There were some minor deviations from protocol: some patients with no prior therapy and some who switched for reasons other than insufficient IOP control were included in the analysis. The mean IOP was reduced by 27.4%, from 22.2 mmHg to 16.1 mmHg. In subgroup analyses, the mean IOP was significantly reduced from baseline, irrespective of whether previous treatment was monotherapy or combination therapy, and preserved or PF therapy. Physicians mostly (88.1%) reported the IOP-lowering efficacy of PF FC bimatoprost 0.03%/timolol 0.5% to be as expected or better than expected. Switching to PF FC bimatoprost 0.03%/timolol 0.5% resulted in reductions from baseline in the number of patients reporting ocular symptoms. Adverse events were reported by 6.2% of patients, the most common being eye irritation (1.6%) and eye pruritus (1.0%). Physicians reported treatment compliance as better or unchanged compared with prior treatment in almost all patients (93.9%). Most patients were expected to continue PF FC bimatoprost 0.03%/timolol 0.5% after the end of the study.

Conclusion: Switching to PF FC bimatoprost 0.03%/timolol 0.5% was associated with significant IOP reductions from baseline over 12 weeks. Adverse events were uncommon, and compliance was high compared with previous therapy. PF FC bimatoprost 0.03%/timolol 0.5% may be a suitable treatment for patients with inadequately controlled IOP or who are sensitive to preservatives.

Keywords: bimatoprost 0.03%/timolol 0.5%; fixed combination; glaucoma; intraocular pressure; preservative free; prostaglandin.

Figures

Figure 1
Figure 1
Prior intraocular pressure-lowering therapy reported in ≥5% of patients (per-protocol population). Note: The image includes patients receiving monotherapy or combination therapy (n=1,352).
Figure 2
Figure 2
Percentage of patients on previous intraocular pressure-lowering treatment taking different numbers of therapies.
Figure 3
Figure 3
IOP in patients who switched from a prior IOP-lowering monotherapy to PF FC bimatoprost 0.03%/timolol 0.5% (per-protocol population). Notes: Data reported for the study eye in patients with complete data at all visits. *P<0.0001 (paired t-test). Abbreviations: BB, beta blocker; CAI, carbonic anhydrase inhibitor; FC, fixed combination; IOP, intraocular pressure; PF, preservative free; PGA, prostaglandin analog.
Figure 4
Figure 4
IOP in patients who switched from prior IOP-lowering monotherapy or combination therapy to PF FC bimatoprost 0.03%/timolol 0.5% (per-protocol population). Notes: (A) IOP in patients who switched from preserved and nonpreserved prior IOP-lowering monotherapy to PF FC bimatoprost 0.03%/timolol 0.5% (per-protocol population). (B) IOP in patients who switched from preserved and nonpreserved prior IOP-lowering fixed-dose combination therapy to PF FC bimatoprost 0.03%/timolol 0.5% (per-protocol population). Data reported for the study eye in patients with complete data at all visits. *P<0.0001 (paired t-test). #Preservative status not disclosed/PF formulation not available. Abbreviations: Bim, bimatoprost; Bzd, brinzolomide; Dzd, dorzolamide; FC, fixed combination; IOP, intraocular pressure; Lat, latanoprost; P, preserved; PF, preservative free; PGA, prostaglandin; Taf, tafluprost; Trav, travatan.
Figure 5
Figure 5
Effect of PF FC bimatoprost 0.03%/timolol 0.5% on ocular symptoms (per-protocol population). Abbreviations: FC, fixed combination; PF, preservative free.

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