A 12-week Study Evaluating the Efficacy of Bimatoprost 0.03% in Patients with Pseudoexfoliative and Open-Angle Glaucoma

Abstract

Purpose

To evaluate the control of diurnal intraocular pressure (IOP) and the safety profile of bimatoprost in pseudoexfoliative glaucoma (PXG) compared to primary open angle glaucoma (POAG).

Methods

A prospective, observer-masked, nonrandomized study was performed. Seventy consecutive patients with either POAG (35 eyes) or PXG (35 eyes) drug-naive for glaucoma were assigned to receive bimatoprost 0.03% once daily for 12 weeks. Diurnal IOP was measured at baseline and after 12 weeks at three time points (8 AM, noon, and 4 PM). Main outcomes were diurnal IOP control and achievement of target IOP (CIGTS criteria). Mean diurnal IOP, hour-by-hour IOP measurements, and safety, including serious adverse events, were also evaluated.

Results

A significant IOP reduction from baseline was found in both groups (p<0.001). Mean and hour-by-hour IOP differences between groups were not statistically significant (NS). The observed IOP values and percentages of IOP reduction were 17.0 mmHg (31.5%) and 16.4 mmHg (31.9%) in PXG and POAG eyes, respectively; the differences were not statistically significant. Six eyes (1 POAG and 5 PXG, respectively) responded with a <20% IOP reduction (NS). Twenty-seven POAG (77.1%) and 23 PXG (65.7%) eyes achieved target IOP. Consequently, 20 eyes (8 POAG and 12 PXG, respectively) were classified as unable to achieve the IOP target values (NS).

Conclusions

Bimatoprost was effective and safe in lowering IOP both in open angle and pseudoexfoliative glaucoma, achieving target pressure in most patients. However, long-term efficacy in PXG must be evaluated.