Viatris Inc. (NASDAQ: VTRS), a US-based global healthcare company, announced on Monday the United States commercial launch of RYZUMVI (Phentolamine ophthalmic solution) 0.75%.
RYZUMVI is intended for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic (e.g., tropicamide) agents in the United States. It is now the only United States commercially available FDA-approved eye drop to reverse dilation.
RYZUMVI received United States Food and Drug Administration (FDA) approval in September 2023. It was evaluated across 2 randomised, vehicle-controlled, double-masked MIRA-2 and MIRA-3 clinical trials in which patients (N=553) aged 12 to 80 years who had mydriasis induced by instillation of phenylephrine, tropicamide, or PAREMYD (hydroxyamphetamine hydrobromide and tropicamide) were administered 2 drops (in the study eye) or 1 drop (in the fellow eye) of either RYZUMVI or placebo one hour after instillation of the mydriatic agent. The onset of action of RYZUMVI generally occurs in 30 minutes.
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