24-Hour IOP Control with BBFC in OHT patients

PURPOSE

• To determine the intraocular pressure (IOP)-lowering effect of fixed-combination brinzolamide 1%/brimonidine 0.2% (BBFC) over a 24-hour period.

Prospective, multicenter, double-masked, parallel-group clinical trial

MAIN OUTCOME MEASURE

• Mean change from baseline in 24-hour IOP at week 4

RESULTS

• Of 125 participants randomized, 123 (98%; BBFC, n = 62; vehicle, n = 61) completed the study.
• At week 4, BBFC-treated eyes had significantly reduced mean 24-hour IOP vs. vehicle (least squares mean difference [95% confidence interval]: -2.5 [-3.3, -1.7]; P < 0.001); daytime (-3.4 [-4.3, -2.6]; P < 0.001) and nocturnal (-1.2 [-2.3, 0.0]; P = 0.053) reductions were observed.
• Mean change from baseline was significantly different between BBFC- and vehicle-treated eyes at all daytime points and 3 of 5 nocturnal time points (10 pm, 12 am, and 6 am; secondary end point).
• The frequency of adverse events was similar between treatment groups.

CONCLUSION

This large, multicenter study of 24-hour IOP control with BBFC met its primary end point; BBFC demonstrated significantly superior 24-hour IOP-lowering efficacy versus vehicle after 4 weeks of 3-times-daily treatment in subjects with OAG or OHT.

 TAKE AWAY MESSAGE

• In a cohort of patients with open-angle glaucoma or ocular hypertension, the authors found that a fixed-dose combination of brinzolamide 1%/ brimonidine 0.2% administered three times daily for 4 weeks was significantly more effective at lowering intraocular pressure (IOP) over a 24-hour period than vehicle alone.
• These are significant findings with respect to managing nocturnal IOP peaks in patients with open-angle glaucoma.

REFERENCE

Ophthalmology 2019 Aug 01;126(8)1095-1104, RN Weinreb, J Bacharach, RD Fechtner, MY Kahook, D Wirta, S Burmaster, X Meng, DA Hubatsch