Efficacy and safety of brinzolamide/timolol fixed combination compared with timolol in Japanese patients with open-angle glaucoma or ocular hypertension

Abstract

Keiji Yoshikawa,1 Jun Kozaki,2 Hidetaka Maeda3 1Yoshikawa Eye Clinic, Tokyo, Japan; 2Kozaki Eye Clinic, Osaka, Japan; 3Maeda Eye Clinic, Osaka, Japan Purpose: To evaluate the efficacy and safety of brinzolamide 1%/timolol 0.5% fixed-combination (BRINZ/TIM-FC) therapy compared with timolol 0.5% (TIM) monotherapy in Japanese patients with open-angle glaucoma or ocular hypertension. Methods: This randomized, double-masked, multicenter study included Japanese patients aged ≥20 years. Patients were treated during a 4-week observation period with TIM monotherapy in advance of randomization to treatment with topical BRINZ/TIM-FC or TIM monotherapy twice daily for 8 weeks. The primary endpoint was mean reduction in intraocular pressure (IOP) from baseline to week 8 at 2 hours postinstillation. Adverse events (AEs) were recorded at each visit. Results: A total of 301 patients (BRINZ/TIM-FC, n=150; TIM, n=151; age [mean ± standard deviation], 61±13 years) were enrolled. Mean IOP reductions from baseline were greater with BRINZ/TIM-FC than with TIM at weeks 4 and 8 at 0 and 2 hours postinstillation (all P≤0.0001), with mean reductions of -3.2 mmHg with BRINZ/TIM-FC and -1.4 mmHg with TIM at week 8, 2 hours postinstillation. Although AEs were observed in 19% of all patients (BRINZ/TIM-FC, 20%; TIM, 19%), all AEs were mild or moderate. Conclusion: BRINZ/TIM-FC therapy was associated with significantly greater reductions in IOP compared with TIM, and it was well tolerated in Japanese patients with open-angle glaucoma or ocular hypertension. Keywords: Azarga, intraocular pressure, carbonic anhydrase inhibitor, beta blocker