Brinzolamide/brimonidine fixed-dose combination bid as an adjunct to a prostaglandin analog for open-angle glaucoma/ocular hypertension. Issue 1 (January 2021)

• Record Type: Journal Article
• Authors: Topouzis, Fotis; Goldberg, Ivan; Bell, Katharina; Tatham, Andrew J; Ridolfi, Antonia; Hubatsch, Douglas; Nicolela, Marcelo; Denis, Phillipe; Lerner, S Fabian
• Is Part Of: European journal of ophthalmology. Volume 31:Issue 1(2021)
• Page Start: 103
• Page End: 111
• Publication Date: 2021-01
• Subjects: Brinzolamide/brimonidine fixed-dose combination -- open-angle glaucoma -- ocular hypertension -- prostaglandin analogs -- intraocular pressure reduction; Ophthalmology -- Periodicals; Eye -- Diseases -- Periodicals; 617.7005
• DOI: 10.1177/1120672119878044
• Languages: English
• ISSNs: 1120-6721

Abstract

Purpose: To evaluate the additive intraocular pressure–lowering effect of twice-daily brinzolamide 1%/brimonidine 0.2% fixed-dose combination (BBFC) as an adjunct to a prostaglandin analog (PGA) in patients with open-angle glaucoma or ocular hypertension insufficiently controlled with PGA monotherapy. Methods: In this Phase 4, double-masked trial, patients aged ⩾18 years, with a mean intraocular pressure of ⩾19 and <32 mm Hg in at least one eye were randomized (1:1) to receive BBFC + PGA ( n = 96) or vehicle + PGA ( n = 92) for 6 weeks. The primary endpoint was the mean change in diurnal intraocular pressure from baseline (averaged over 09:00 and 11:00 h) at Week 6. Results: The mean diurnal intraocular pressure at baseline was similar in the BBFC + PGA (22.8 mm Hg) and vehicle + PGA (22.9 mm Hg) groups. The least squares mean change in diurnal intraocular pressure from baseline at Week 6 was greater with BBFC + PGA (−5.59 mm Hg (95% confidence interval: −6.2 to −5.0)) than with vehicle + PGA (−2.15 mm Hg (95% confidence interval: −2.7 to −1.6)); the treatment difference was statistically significant in favor of BBFC + PGA (−3.44 mm Hg, (95% confidence interval: −4.2 to −2.7); p < 0.001). Ocular adverse events were reported in 21.1% and 8.7% of patients in the BBFC + PGA and vehicle + PGA groups, respectively. The most frequent ocular adverse event was ocular hyperemia (5.3%) in the BBFC + PGA group and blurred vision (2.2%) in the vehicle + PGA group. Conclusion: BBFC + PGA significantly reduced mean diurnal intraocular pressure than PGA alone in patients with open-angle glaucoma or ocular hypertension. The safety findings with BBFC + PGA were consistent with the known safety profile of the individual medications.