Low-concentration bimatoprost 0.01% and timolol 0.1% eye gel versus bimatoprost 0.03% and timolol 0.5% eye drops in open-angle glaucoma or ocular hypertension: a phase III randomised study

Background/Aims To compare the efficacy and safety of a new preservative-free bimatoprost 0.01%/timolol 0.1% fixed combination (BTFC) eye gel with those of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (BTFC eye drops) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). Methods In this phase III, international, multi-centre, randomised, parallel group, investigator-masked study, patients receiving a first-line monotherapy, having insufficiently controlled intraocular pressure (IOP) and requiring dual therapy were randomised to receive either BTFC eye gel or BTFC eye drops once daily for 12 weeks. The primary efficacy endpoint was the change in IOP from baseline to week 12 at 08:00 in the assessed eye. Further efficacy and safety endpoints were assessed as secondary outcomes. Results The mean±SD change in IOP from baseline to week 12 at 08:00 was −10.96±3.43 mmHg for the BTFC eye gel group and −11.14±3.56 mmHg for the BTFC eye drop group. The least-squares mean difference (BTFC eye gel minus BTFC eye drops) was −0.04±0.24 mmHg (95% CI −0.51 to 0.43 mmHg), with the upper bound of the 95% CI lower than the predefined margin of +1.5 mmHg at week 12 at 08:00. Similar IOP-lowering efficacy was demonstrated at all other timepoints. The safety profile was comparable between the treatment groups. No patients in the BTFC eye gel group discontinued the study due to a treatment-related adverse event compared with 8 (2.9%) patients in the BTFC eye drop group. Conclusion Low-concentration BTFC eye gel can be considered as a safe and effective treatment in the therapeutic management of glaucoma and OHT. No data are available.