The FDA approved a twice-daily dosing option for Vuity for the treatment of presbyopia, AbbVie announced.
The approval allows for a second dose of the drop 3 to 6 hours after the first dose, which may extend the drop’s duration of effect for up to 9 hours.
The approval is supported by data from the phase 3 VIRGO trial in which 114 participants with presbyopia were randomly assigned to receive treatment with Vuity (pilocarpine HCl ophthalmic solution) 1.25% and 116 received placebo. Each dose was administered 6 hours apart for 14 days.
The primary endpoint of the study — the