Safety and tolerability of brimonidine purite 0.1% and brimonidine purite 0.15%: a meta-analysis of two phase 3 studies

ABSTRACT

Objective: To compare the safety and tolerability of two formulations of brimonidine ophthalmic solution, brimonidine Purite (P) 0.1% and brimonidine P 0.15%, for reducing intraocular pressure in patients with glaucoma or ocular hypertension (OHT).

* Purite is a registered trademark of Allergan, Inc., Irvine, CA, USA

Study design and methods: Meta-analysis of safety and tolerability results from two previously reported prospective, randomized, 12-month, double-masked, multicenter, parallel-group clinical studies with similar entry criteria and protocols. In study 1 (two clinical trials), after washout of previous medications, patients with glaucoma or OHT were randomized to thrice-daily treatment with brimonidine P 0.15% (n = 381), brimonidine P 0.2% (n = 383), or brimonidine 0.2% (n = 383). In study 2 (one clinical trial), the treatment arms were thrice-daily brimonidine P 0.1% (n = 215) and brimonidine 0.2% (n = 218).

Main outcome measure: Treatment-related adverse events (AEs) and discontinuations due to AEs.

Results: Treatment-related AEs were significantly reduced with brimonidine P 0.15% compared with brimonidine 0.2% in study 1 (p < 0.001). Treatment-related AEs and discontinuations due to AEs were significantly reduced with brimonidine P 0.1% compared with brimonidine 0.2% in study 2 (p ≤ 0.014). In the meta-analysis of study 1 and study 2, the overall incidence of treatment-related AEs was lower with brimonidine P 0.1% than with brimonidine P 0.15% (41.4 vs. 49.7%; p = 0.050). Although the incidence of treatment-related ocular AEs was similar with brimonidine P 0.1% and 0.15% (p = 0.461), treatment-related systemic AEs were less frequent with brimonidine P 0.1% than with brimonidine P 0.15% (4.7 vs. 14.2%; p < 0.001), and there were fewer discontinuations due to systemic AEs with brimonidine P 0.1% than with brimonidine P 0.15% (p = 0.025).

Conclusions: Brimonidine P 0.1% has improved systemic safety and tolerability compared with brimonidine P 0.15%. The ocular safety and tolerability of the formulations are similar. The present meta-analysis is based on only two clinical studies, and additional studies further evaluating the safety and tolerability of these medications are warranted.

Key words: :

• Alpha-adrenergic agonist
• Brimonidine
• Glaucoma
• Intraocular pressure
• Ocular hypertension

Transparency

Declaration of funding

This study was sponsored by Allergan, Inc.

Declaration of financial/other relationships

C.L., A.L.B. and D.A.H. have disclosed that they are employees of Allergan. L.B.C. has disclosed that he has no proprietary interest in the study drug, but he has received research funding and travel honoraria from, and serves as a consultant for, Allergan.

All peer reviewers receive honoraria from CMRO for their review work. Peer Reviewer 1 and Peer Reviewer 2 have disclosed that they have no relevant financial relationships.

Acknowledgment

The authors thank Kate Ivins, PhD, for her writing/editorial assistance.

Notes

* Purite is a registered trademark of Allergan, Inc., Irvine, CA, USA

* Alphagan and Purite are registered trademarks of Allergan, Inc., Irvine, CA, USA