April 5, 2023
The FDA approved a twice-daily dosing option of VUITY (pilocarpine HCl ophthalmic solution) 1.25% in adults with presbyopia, according to AbbVie, the makers of VUITY.
A second dose (one additional drop in each eye) may be administered 3-6 hours after the first dose. Presbyopia, or age-related blurry near vision, is a common and progressive eye condition that affects an estimated 128 million Americans, or nearly half of the U.S. adult population.
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With the approval of twice-daily dosing, the duration of effect of VUITY may be extended for up to nine hours. The approval is based on results from the double-masked Phase 3 VIRGO trial in which 230 participants aged 40-55 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 six hours apart, for 14 days.
The primary endpoint of the proportion of participants gaining three lines (the ability to read three additional lines on a near vision chart) or more in mesopic (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 9 (three hours after the second drop) versus the vehicle (placebo) was met (35.1 percent vs 7.8 percent, p<0.0001).
The most common adverse reactions reported in >5 percent of participants were headache and eye irritation. Ocular adverse reactions reported in 1-5 percent of participants were visual impairment, eye pain, blurred vision and vitreous floaters.
