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ObjectiveThe aim of this study was to evaluate the safety and efficacy of a fixed combination of bimatoprost 0.03% and timolol (BTFC) in a clinical setting, in a large sample of patients with primary open-angle glaucoma or ocular hypertension and insufficient intraocular pressure (IOP) lowering on prior therapy.MethodsPatient data were combined (n = 5556) from five multicenter, observational, non-controlled, open-label studies throughout Europe. Patients were identified from 830 sites in Austria, France, Germany, The Netherlands, and Switzerland. Assessments were made at baseline, 6 weeks (in Austrian, German and Swiss centers), and 12 weeks in all centers.ResultsBTFC lowered mean IOP from baseline by 5.4 mmHg over the 12-week duration of the studies (P < 0.0001). At study entry, 92.9% of patients were receiving another ocular hypotensive medication. In patients with no previous treatment (n = 311), BTFC reduced IOP by −9.1 mmHg, corresponding to a reduction from baseline of 36.4% (P < 0.0001). In patients receiving prior therapy of a prostaglandin analog, a β-blocker, or a fixed combination, BTFC reduced IOP by a further 24.5%, 25.9%, and 21.4%, respectively. The majority of patients (90.3%) reported no adverse events. The most common adverse events were conjunctival hyperemia (3.2%) and eye irritation (2.8%). BTFC was rated as “good” or “very good” by 92.5% of physicians and 88.0% of patients. Most patients (96.3%) were equally or more compliant with BTFC than with their previous treatment.ConclusionIn routine clinical practice, BTFC achieved consistent IOP lowering in both previously treated and untreated patients with primary open-angle glaucoma or ocular hypertension. BTFC was associated with significant IOP reductions, good tolerability, and good compliance.

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