Combined analysis of five observational studies evaluating the efficacy and tolerability of bimatoprost/timolol fixed combination in patients with primary open-angle glaucoma or ocular hypertension

Purpose To evaluate the efficacy and tolerability of a fixed combination (FC) of bimatoprost 0.3 mg/ml and timolol 5.0 mg/ml (BTFC; Ganfort®) in patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT). Methods This was a combined analysis of five prospective, observational studies involving 5556 patients from 830 centres in Germany, Switzerland, Netherlands, Austria and France. All treatment decisions were at the physician’s discretion. Results In the study population, 78% had POAG and the remainder had OHT. Patients were monitored for a median of 14 weeks. Overall, 93% (n = 5164) had received prior therapy; 47% receiving timolol. The most frequent reason for switching to BTFC (in 81% of patients with prior therapy) was insufficient intraocular pressure (IOP) control. Over the treatment period, mean IOP decreased from 21.5 to 16.1 mmHg with BTFC (25% reduction). BTFC reduced IOP in patients previously receiving prostaglandin monotherapy, β-blocker, carbonic anhydrase inhibitor (CAI) and FCs containing a prostaglandin or CAI plus β-blocker. In categorical analyses, physicians rated BTFC efficacy as ‘very good’ or ‘good’ in 86% of patients. BTFC tolerability was rated ‘very good’ or ‘good’ by 70% of physicians and 65% of patients. Adverse events were recorded for 9.7% (n = 541) of patients: the most common were eye irritation (2.8%) and ocular hyperaemia (2.2%). Conclusion When used in a real-life clinical setting, BTFC was well tolerated and effective in the management of POAG and OHT. Commercial interest