Additive effects of brimonidine tartrate 0.1%/brinzolamide 1% fixed-dose combination in prostaglandin analog-treated Japanese glaucoma patients

• Published in: Japanese journal of ophthalmology Vol. 67; no. 6; pp. 668 - 677
• Main Authors: Sakata, Rei, Mizoue, Shiro, Yoshikawa, Keiji, Adachi, Misato, Ohkubo, Shinji, Hamada, Naoki, Naito, Tomoko, Muramatsu, Tomoyuki, Hara, Takeshi, Asato, Ryo, Aihara, Makoto
• Format: Journal Article
• Language: English
• Published: Tokyo Springer Japan 01-11-2023; Springer Nature B.V
• Subjects: Acuity; Clinical Investigation; Complications; Glaucoma; Hypertension; Intraocular pressure; Medicine; Medicine & Public Health; Ophthalmology; Safety; Visual acuity; Prostaglandin analogs; Brimonidine tartrate 0.1%/brinzolamide 1% fixed-dose combination; Prostaglandin analogs/beta-blocker fixed-dose combination; Primary open-angle glaucoma; Intraocular pressure
• ISSN: 0021-5155; 1613-2246
• DOI: 10.1007/s10384-023-01022-6

Purpose
A brimonidine tartrate 0.1%/brinzolamide 1% fixed-dose combination (BBFC) was recently approved for glaucoma and ocular hypertension treatment in Japan. We investigated the efficacy and safety of BBFC used concomitantly with prostaglandin analogs (PG) or a PG/beta-blocker fixed-dose combination (PG/beta FC).
Study design
This was a prospective, open-label, multicenter study.
Patients and methods
We enrolled Japanese patients with open-angle glaucoma. BBFC (Ailamide) was concomitantly administered to either the PG or the PG/beta FC group, and intraocular pressure (IOP) and safety were evaluated at 4 and 12 weeks. The groups were stratified into low and high IOP baseline groups based on the median baseline IOP.
Results
We enrolled 100 patients, 91 of whom completed the 12-week follow-up. The mean ages were 67.1 and 65.7 years in the PG group (n = 45, baseline IOP of 15.7 ± 2.3 mmHg) and the PG/beta FC group (n = 46, baseline IOP of 16.3 ± 2.3 mmHg), respectively. After BBFC administration, IOPs at 4 and 12 weeks were 13.0 ± 2.0 and 13.0 ± 2.6 mmHg (
P
< 0.0001) in the PG group, respectively, and 13.7 ± 2.4 and 13.7 ± 2.2 mmHg (
P
< 0.0001) in the PG/beta FC group, respectively. IOP decreased by – 2.0 ± 1.8 mmHg (
P
< 0.0001) and –1.9 ± 1.4 mmHg (
P
< 0.0001) in the low baseline PG group (14.1 mmHg) and low baseline PG/beta FC group (14.8 mmHg) at 12 weeks, respectively. Sixteen adverse events were identified, all of which were common and did not affect visual acuity.
Conclusions
BBFC can be used concomitantly with PG or PG/beta FC to reduce IOP without serious complications.