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
Author(s)
Cordeiro, M Francesca
Oddone, Francesco
Mermeklieva, Elena Atanasova
Rokicki, Dariusz MD
Nissle, Sylvie
Type
Journal Article
Abstract
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.
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.
Date Issued
2026-04-01
Date Acceptance
2025-10-01
Citation
British Journal of Ophthalmology, 2026, 110 (4), pp.403-409
ISSN
0007-1161
Publisher
BMJ Publishing Group
Start Page
403
End Page
409
Journal / Book Title
British Journal of Ophthalmology
Volume
110
Issue
4
Copyright Statement
© Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.
License URL
Identifier
https://www.ncbi.nlm.nih.gov/pubmed/41093358
PII: bjo-2025-327555
Subjects
Drugs
EFFICACY
FIXED COMBINATION
Glaucoma
INDIVIDUAL COMPONENTS
Intraocular pressure
INTRAOCULAR-PRESSURE
LATANOPROST
Life Sciences & Biomedicine
Ocular Hypertension
Ophthalmology
SAFETY
Science & Technology
Treatment Medical
Publication Status
Published
Coverage Spatial
England
Date Publish Online
2025-10-14