FDA Approves Twice-Daily Dosing of Vuity for Adults with Presbyopia

The FDA has approved a twice-daily dosing option of Vuity (pilocarpine HCl ophthalmic solution) 1.25% in adults with presbyopia, according to AbbVie, the parent company of Allergan. A second dose (one additional drop in each eye) may be administered 3-6 hours after the first dose. With the approval of twice-daily dosing, the duration of effect of Vuity may be extended for up to 9 hours.

The approval is based on results from the double-masked phase 3 VIRGO trial in which 230 participants aged 40 to 55 years old with presbyopia were randomized to Vuity (n=114) or placebo (vehicle alone, n=116), receiving one drop in each eye twice daily, with each dose administered 6 hours apart, for 14 days. The primary endpoint of the proportion of participants gaining 3 lines or more in mesopic, high contrast, binocular Distance Corrected Near Visual Acuity (DCNVA) with no more than 5-letter loss in low light Corrected Distance Visual Acuity (CDVA) at Day 14, Hour 9 (3 hours after the second drop) versus the vehicle (placebo) was met (35.1% vs 7.8%, P<0.0001). 

The most common adverse reactions reported in >5% of participants were headache and eye irritation. Ocular adverse reactions reported in 1-5% of participants were visual impairment, eye pain, blurred vision, and vitreous floaters. 

Vuity was FDA-approved for once-daily dosing in October 2021. See full Prescribing Information at www.VUITY.com.