S. Melamed and S. Rothberg

The efficacy, safety and tolerability profile of brimonidine 0.2% was gathered from clinical comparison trials and from four years of practical use as therapy for ocular hypertension and glaucoma. The results from clinical trials including an ongoing multi-year, multi-center, double-masked study comparing brimonidine b.i.d. with timolol 0.5% b.i.d. 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. 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 b.i.d. was also more effective (p=.006) than dorzolamide t.i.d. (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. After approximately four years of clinical study and practical use, brimonidine 0.2% b.i.d. 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.