Comparison of the Intraocular Pressure-Lowering Efficacy and Safety of the Brinzolamide/Brimonidine Fixed-Dose Combination versus Concomitant Use of Brinzolamide and Brimonidine for Management of Open-Angle Glaucoma or Ocular Hypertension
Authors Wang N, Lu DW, Pan Y, Astakhov Y, Iureva T, Adewale A, Walker TM
Received 17 September 2019
Accepted for publication 31 December 2019
Published 23 January 2020 Volume 2020:14 Pages 221—230
Checked for plagiarism Yes
Review by Single-blind
Peer reviewer comments 2
Editor who approved publication: Dr Scott Fraser
Ningli Wang,1 Da-Wen Lu,2 Yingzi Pan,3 Yury Astakhov,4 Tatyana Iureva,5 Adeniyi Adewale,6 Thomas M Walker6
1Beijing Tongren Eye Center, Beijing, People’s Republic of China; 2Tri-Service General Hospital, Taipei, Taiwan; 3Peking University First Hospital, Beijing, People’s Republic of China; 4Pavlov First Saint Petersburg State Medical University, Saint Petersburg, Russia; 5Irkutsk Branch of the Academician S.N. Fyodorov Eye Microsurgery Federal State Institution, Irkutsk, Russia; 6Novartis Pharmaceuticals Corporation, Fort Worth, TX, USA
Correspondence: Ningli Wang
Beijing Tongren Eye Center, No. 1 Dongjiaomin Str., Dongcheng District, Beijing 100041, People’s Republic of China
Objective: To demonstrate that the intraocular pressure (IOP)-lowering efficacy of a twice-daily brinzolamide 10 mg/mL (BRINZ)/brimonidine 2 mg/mL (BRIM) fixed-dose combination (BBFC) was non-inferior to its individual components (BRINZ+BRIM) dosed concomitantly in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). Safety was also evaluated.
Methods and Analysis: This was a Phase III, multicenter, observer-masked study in patients from China, Russia and Taiwan. Patients aged ≥ 18 years with a mean IOP ≥ 21 mmHg and ≤ 36 mmHg in the same eye after washout of other IOP-lowering medications were included. Eligible patients were randomized (1:1) to receive BBFC or BRIZ+BRIM eye drops twice daily for 3 months. The primary endpoint was the mean change in diurnal IOP (averaged over 09:00, +2 h, and +7 h) from baseline to Month 3. Adverse events (AEs) were recorded throughout the study.
Results: The per-protocol set included 349 patients (BBFC, n=172; BRINZ+BRIM, n=177). The mean±standard deviation diurnal IOP at baseline was 24.6± 2.66 mmHg in both groups. At Month 3, the least square mean±standard error change in diurnal IOP from baseline was − 7.2± 0.34 mmHg and − 7.3± 0.34 mmHg with BBFC and BRINZ+BRIM, respectively (between-group difference: 0.1 mmHg [95% CI − 0.5, 0.7]). In the BBFC and BRINZ+BRIM groups, 53.3% and 55.0% of patients achieved a diurnal IOP < 18 mmHg, and 43.2% and 37.4% of patients, respectively, achieved a mean diurnal IOP reduction > 30% from baseline at Month 3. Ocular AEs were reported in 28.7% (BBFC) and 22.5% (BRINZ+BRIM) of patients; conjunctival hyperemia was the most frequent ocular AE (BBFC, 6.4%; BRINZ+BRIM, 6.8%). Non-ocular AEs were reported in 32.4% (BBFC) and 30.4% (BRINZ+BRIM) of patients.
Conclusion: The study findings demonstrate that the efficacy of twice-daily BBFC was non-inferior to BRINZ+BRIM in patients with OAG/OHT. The safety profile of BBFC was similar to that of BRINZ+BRIM.
Keywords: brinzolamide/brimonidine fixed-dose combination, intraocular pressure reduction, ocular hypertension, open-angle glaucoma
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