The FDA has approved a twice-daily dosing option of VUITY® (pilocarpine HCl ophthalmic solution) 1.25% in adults with presbyopia. 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.
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 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 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.
About VUITY
VUITY is an optimized formulation of pilocarpine specifically designed to treat age-related blurry near vision. VUITY, previously FDA-approved for once-daily dosing in October 2021, uses the eye's ability to reduce pupil size, to improve near and intermediate vision while maintaining some pupillary response to light. Please see full Prescribing Information at www.VUITY.com.