Efficacy of a preservative-free fixed combination of bimatoprost and timolol in treatment-naïve versus previously treated patients

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Abstract

Purpose

To evaluate the intraocular pressure (IOP)-lowering efficacy of a preservative-free formulation of fixed-combination bimatoprost/timolol (FCBT PF) in treatment (tx)-naïve vs previously treated patients.

Methods

A double-masked, randomized, parallel-group study compared FCBT PF with preserved FCBT (Ganfort) in 561 patients diagnosed with glaucoma or ocular hypertension who were tx naïve or had inadequate IOP lowering with previous tx. IOP was measured at 0, 2, and 8 hours at baseline and weeks 2, 6, and 12. Subgroup analysis evaluated average IOP change from baseline in tx-naïve vs previously treated, washed out patients.

Results

FCBT PF was equivalent to Ganfort, producing numerically greater (0.2 to 0.5 mmHg) IOP lowering than Ganfort during follow-up. With FCBT PF, IOP mean changes from baseline (mmHg) ranged from −8.7 to –9.8 in tx-naïve patients (n=50) and –7.3 to –8.5 in previously treated patients (n=228). Baseline IOP, age, diagnosis, and corneal pachymetry were significant covariates of IOP lowering. In an analysis of covariance model with these factors as covariates, differences between tx-naïve and previously treated patients ranged from 0.8 to 1.7 mm Hg favouring tx-naive patients and were significant (p≤0.018) at 7 of 9 timepoints.

Conclusion

FCBT PF had a favourable IOP-lowering effect compared with Ganfort and reduced IOP more effectively in tx-naïve than previously treated patients. This can be attributed in part to the removal of preservative (BAK) optimizing the efficacy of timolol in FCBT PF.

Conclusion

Commercial interest

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