April 11, 2023
NORTH CHICAGO, Ill. – AbbVie, the parent company of Allergan, has announced that the FDA has approved a twice-daily dosing option of Vuity (pilocarpine HCl ophthalmic solution) 1.25% in adults with presbyopia. Vuity is the first and only eye drop to treat presbyopia. The FDA had approved Vuity for once-daily dosing in October 2021. With this latest approval, a second dose (one additional drop in each eye) may be administered three to six hours after the first dose. With twice-daily dosing, the duration of effect of Vuity may be extended for up to nine hours.
The approval for twice-daily dosing in adults with presbyopia is based on results from the double-masked Phase 3 VIRGO trial in which 230 participants ages 40 to 55 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 six hours apart, for 14 days. The primary endpoint of the proportion of participants gaining three lines or more in low light, high contrast, binocular Distance Corrected Near Visual Acuity (DCNVA) with no more than five-letter loss in low light Corrected Distance Visual Acuity (CDVA) at Day 14, hour nine (three 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.
