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This phase III international randomised trial evaluated the efficacy and safety of a new low concentration bimatoprost/timolol eye gel (bimatoprost 0.01%/timolol 0.1%). It was compared with the conventional higher-strength fixed combination eye drops (bimatoprost 0.03%/timolol 0.5%) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT) inadequately controlled on monotherapy. The study was investigator-masked and conducted across 83 centres in Europe, India, Russia and Tunisia. A total of 554 adults were randomised after a 4-week washout of previous prostaglandin analogue or β-blocker therapy. Eligible patients had bilateral OAG or OHT with baseline intraocular pressure (IOP) ≥22mmHg in both eyes, corneal thickness between 500–600µm, and mild-to-moderate disease. Participants administered 1 drop in each eye once daily for 12 weeks, with follow-up at weeks 6 and 12. At week 12, mean IOP reductions were -10.96mmHg with the low-concentration gel and -11.14mmHg with the standard drops. The adjusted mean difference between groups was -0.04mmHg (95% CI -0.51 to 0.43), confirming non-inferiority. Both formulations showed similar diurnal IOP control and efficacy across OHT and OAG subgroups. Conjunctival hyperaemia was the most frequent treatment-related ocular event (9.4% with the gel vs. 13.1% with the drops). No serious ocular adverse events occurred. Investigators and patients rated tolerance higher with the gel at both follow-up visits. These findings suggest that the low-concentration bimatoprost/timolol gel offers comparable pressure reduction with better comfort and tolerability, supporting its use in long-term glaucoma management. The authors acknowledge that longer-term studies are needed to confirm whether the improved tolerability of the gel translates into better adherence, sustained IOP control and long-term visual outcomes.

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.
Cordeiro MF, Oddone F, Mermeklieva EA, et al. 
BRITISH JOURNAL OF OPHTHALMOLOGY
2025:bjo-2025-327555. ePub ahead of print.
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Rickvir Sidhu

Royal Berkshire Hospital, Reading, UK.

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