Presbyopes who manage their near vision needs with AbbVie's presbyopia drop Vuity (pilocarpine HCl 1.25%) but find themselves frustrated when results wear off mid-day will be glad to hear that the FDA just approved a twice-daily dosing option for the drug. According to the new labeling, a second dose (one additional drop in each eye) may be administered three to six hours after the first one. The company says this can extend the effect of Vuity to up to a total of nine hours between the two doses.
The approval is based on results from the double-masked Phase III 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). Just over one-third of subjects (35.1%) experienced a three-line gain in near vision at hour nine without losing more than one line of distance acuity, AbbVie said in a press release.
The most common adverse reactions reported in >5% of participants were headache and eye irritation. Ocular adverse reactions reported in 1% to 5% of participants were visual impairment, eye pain, blurred vision and vitreous floaters.
|With a newly approved twice-daily dosing option, Vuity users may extend the drug’s effect for up to nine hours. Click image to enlarge.|