Purpose: To evaluate the efficacy, safety and
tolerability profile of brimonidine 0.2% gathered from clinical comparison
trials and from four years of practical use as therapy for ocular hypertension
and glaucoma. Methods: Results from clinical trials including an ongoing
multi-year, multi-center, double-masked study comparing brimonidine BID with
timolol 0.5% BID will be presented, in addition to current post-market
surveillance. Reduction of IOP from baseline, visual fields, ocular and systemic
safety, and AE reports were monitored.
Results: In clinical trials, brimonidine provided
mean IOP lowering and individual clinical success rates superior to betaxolol
and comparable to timolol. In year 3, brimonidine and timolol produced
equivalent IOP-lowering at trough and preserved visual fields in 95% of
patients; ocular allergy occurred in 4.2% (2/48) of brimonidine-treated
patients. Brimonidine BID was also more effective (p=.006) than dorzolamide TID
(n=106), and similarly effective as latanoprost QD, when used as adjunctive
agents. Post market surveillance revealed no published reports of serious
drug-related adverse events in adults.
Conclusions: After approximately four years of clinical
study and practical use, brimonidine 0.2% BID continues to appear safe,
well-tolerated and highly effective as long-term therapy for ocular
hypertension and glaucoma, warranting its use as a first-line and adjunctive
regimen.