Multicenter, prospective, open-label, observational study of bimatoprost 0.01% in patients with primary open-angle glaucoma or ocular hypertension

Bimatoprost 0.01% was developed for improved tolerability over bimatoprost 0.03%, while maintaining efficacy in lowering intraocular pressure (IOP). This multicenter, prospective, open-label, observational study was designed to investigate the efficacy and tolerability of bimatoprost 0.01% in routine clinical practice. Data were collected from 10,337 patients with primary open-angle glaucoma or ocular hypertension attending 1334 centers in Germany. The primary efficacy outcome was mean change in IOP in each eye from baseline to 10-14 weeks after initiation of bimatoprost 0.01%. Target IOP, prior therapies, additional treatments, and adverse events were also assessed. All treatment decisions were at the physicians' discretion. Bimatoprost 0.01% significantly lowered mean IOP from baseline by -4.1 mmHg (P < 0.0001) in all patients after a mean of 10.45 weeks. In patients without previous treatment, bimatoprost 0.01% reduced mean IOP from baseline by -6.5 mmHg (P < 0.0001). Bimatoprost 0.01% also significantly reduced IOP in patients previously treated with monotherapy of β-blockers, prostaglandin analogs, carbonic anhydrase inhibitors or bimatoprost 0.03%. No adverse events were reported by 93.9% of patients during treatment with bimatoprost 0.01%; the most commonly reported adverse events were eye irritation (2.0%), ocular hyperemia (1.4%), and conjunctival hyperemia (1.2%). Physicians and patients rated tolerability and adherence as high, and most patients said they would continue with bimatoprost 0.01% treatment. Bimatoprost 0.01% can produce additional IOP-lowering effects when used in routine clinical practice in patients who have received prior therapy, in addition to lowering IOP in previously untreated patients. A high rate of continuation of therapy with bimatoprost 0.01% was observed in patients who switched from a variety of different medications. The results suggest that bimatoprost 0.01% is a suitable first-choice therapy in patients with primary open-angle glaucoma or ocular hypertension.