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TFC-003-R1 is a fixed-dose combination ophthalmic solution containing brimonidine tartrate and timolol maleate. It serves as the reference drug (specifically the brand-name product Combigan) in clinical trials, such as the Phase 3 study KJ-TFC-005 conducted by Kukje Pharma, to evaluate the therapeutic equivalence of generic candidates like TFC-003. Brimonidine is a selective alpha-2 adrenergic receptor agonist that lowers intraocular pressure (IOP) by reducing the production of aqueous humor and increasing its outflow through the uveoscleral pathway. Timolol is a non-selective beta-adrenergic receptor antagonist that reduces IOP primarily by decreasing aqueous humor secretion from the ciliary body. This combination is indicated for the reduction of elevated IOP in patients with primary open-angle glaucoma or ocular hypertension who are insufficiently controlled by monotherapy.
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