FDA approves twice-daily dosing option for Vuity

The U.S. Food and Drug Administration has approved a twice-daily dosing option of Vuity (pilocarpine HCl ophthalmic solution) 1.25% in adults with presbyopia, according to a press release.

The second dose may be administered 3-6 hours after the first dose, extending the duration of effect for up to 9 hours.

Approval was based on the results of a Phase 3 trial involving 230 participants aged 40 to 55 years old. The trial found that Vuity was effective in improving Distance Corrected Near Visual Acuity in low light conditions, with a significantly higher proportion of participants gaining 3 lines or more compared to the placebo group.