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

AbbVie, the parent company of Allergan, has announced that the FDA has granted approval for the use of Vuity (pilocarpine HCl ophthalmic solution) 1.25% twice a day in adults suffering from presbyopia. The second dose, consisting of an additional drop in each eye, can be administered 3-6 hours after the initial dose. This approval for twice-daily dosing of Vuity may prolong its effectiveness for up to 9 hours.

The basis for approval of Vuity for twice-daily dosing in adults with presbyopia comes from the double-masked phase 3 VIRGO trial. In this trial, 230 participants aged 40 to 55 years old with presbyopia were randomized to receive either Vuity (n=114) or placebo (vehicle alone, n=116) for 14 days. Each participant received one drop in each eye twice daily, with each dose administered 6 hours apart.

The primary endpoint of the trial was the proportion of participants who gained 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) compared to the vehicle (placebo). The results showed that the primary endpoint was met, with 35.1% of participants in the Vuity group achieving the desired improvement in visual acuity, compared to only 7.8% in the placebo group (P<0.0001).

The most frequently reported adverse reactions in the VIRGO trial were headache and eye irritation, occurring in over 5% of the participants. Ocular adverse reactions such as visual impairment, eye pain, blurred vision, and vitreous floaters were reported in 1-5% of the participants.

 Vuity received FDA approval for once-daily dosing in October 2021.