Combigan® is a fixed combination made up of brimonidine tartrate (0.2%) and timolol (0.5%, as maleate), two commonly used intraocular pressure (IOP)-lowering agents with complementary mechanisms of action. This paper describes Combigan safety and efficacy studies undertaken for US and European regulatory approval. The studies show that Combigan produces no unexpected adverse effects and that the fixed combination has non-inferiority to the unfixed combination of the same two agents. Phase III trials in the United States and Europe have demonstrated that Combigan lowers IOP more effectively than either of the two agents alone. Allergic conjunctivitis seems to occur less frequently (half the incidence) with Combigan than with brimonidine (Alphagan®) alone. Overall, Combigan shows similar efficacy and safety to concomitant brimonidine and timolol, and superior efficacy to either agent alone, with a favorable benefit-to-risk ratio.
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