Brimonidine/timolol, sold under the brand name Combigan, is a fixed-dose combination medication eye drop indicated for the treatment of glaucoma. It is a combination of brimonidine (an α2 adrenergic agonist) and timolol (a β adrenergic blocker), in concentrations of 0.2% and 0.5% respectively. Both substances work by decreasing the synthesis of aqueous humor. Combigan is marketed and sold by Allergan. It has been approved by regulatory authorities in Europe, Canada, and the United States for reduction of intraocular pressure (IOP) in patients with glaucoma or ocular hypertension. Although clinical studies showed that the IOP-lowering effect was slightly greater (1-2 mmHg) with concomitant administration of 0.5% timolol twice daily and 0.2% brimonidine tartrate three times daily than with Combigan twice daily, the safety profile of latter was more favorable. Medical uses
Combigan (brimonidine tartrate/timolol maleate) 0.2%/0.5% is used to reduce IOP in patients with glaucoma or ocular hypertension who need adjunctive or replacement therapy. The recommended dosage is one drop administered to the affected eye(s) twice a day, approximately every 12 hours.Both brimonidine 0.2% and timolol 0.5% are commonly used ophthalmic solutions for lowering IOP. Timolol 0.5% is dosed one drop once or twice daily, while brimonidine 0.2% is dosed one drop three times daily. For patients who need more than one medication to lower IOP, the fixed combination product offers the advantages of reducing the number of drops and medication bottles, improving patient compliance, and decreasing ocular exposure to preservatives in ophthalmic solutions.
Similar efficacy results were reported during 12-month follow-up: mean IOP decrease from baseline was 4.4-7.6 mmHg with brimonidine/timolol combination, compared to 2.7-5.5 mmHg with brimonidine and 3.9-6.2 mmHg with timolol. The incidence of treatment-related adverse events with the brimonidine/timolol combination was lower than that with brimonidine monotherapy but higher than that with timolol monotherapy.A 12-week prospective, randomized, double-blinded study in 371 glaucoma and ocular hypertension patients with inadequate IOP control on monotherapy compared the efficacy and safety of 0.2% brimonidine tartrate/0.5% timolol fixed combination twice daily with the concomitant use of 0.2% brimonidine tartrate twice daily and timolol 0.5% twice daily. The IOP-lowering effect of the fixed combination group was shown to be non-inferior to that of concomitant therapy. Incidence of adverse events was similar between groups. Society and culture
Commercial aspects
Allergan is the New Drug Application (NDA) holder of brimonidine tartrate/timolol maleate ophthalmic solution 0.2%/0.5%, which is sold under the COMBIGAN® trademark. The New Drug Application (NDA) for Combigan was approved by the US Food and Drug Administration (FDA) in October 2007. Allergan, Plc is a global specialty pharmaceutical company which develops, manufactures, markets and distributes branded pharmaceutical products, aesthetic products, biosimilar and over-the-counter pharmaceutical products. In 2015, Actavis, Plc acquired Allergan, Inc. for approximately $77 billion and subsequently changed its name to Allergan, Plc. In 2015, the global revenues for Alphagan and Combigan totaled $411.1 million ($285 million from the US market), which accounted for 2.7% of Allergans total net revenues.Allergan holds at least six active patents protecting Combigan from generic competition.