FDA approves twice-daily dosing option of Vuity for presbyopia
Click Here to Manage Email Alerts
Key takeaways:
- A second dose of Vuity 3 to 6 hours after the first dose may extend the effect for up to 9 hours.
- The most commonly reported adverse events were headache and eye irritation.
The FDA approved a twice-daily dosing option for Vuity for the treatment of presbyopia, AbbVie announced.
“In the VIRGO trial, Vuity improved near vision without compromising distance vision for up to 9 hours at day 14,” Sarika Sood, therapeutic area head of U.S. medical affairs, eye care, AbbVie, told Healio/OSN. “The approval of the second dosing option helps eye care professionals tailor presbyopia management for their patients to address individual lifestyle needs.”
Image: Adobe Stock
The approval allows for a second dose of the drop 3 to 6 hours after the first dose, which may extend the drop’s duration of effect for up to 9 hours.
The approval is supported by data from the phase 3 VIRGO trial in which 114 participants with presbyopia were randomly assigned to receive treatment with Vuity (pilocarpine HCl ophthalmic solution) 1.25% and 116 received placebo. Each dose was administered 6 hours apart for 14 days.
The primary endpoint of the study — the proportion of participants who gained three lines or more in mesopic, high-contrast, binocular distance corrected near visual acuity with no more than a loss of five letters in low light corrected distance visual acuity at day 14, hour 9 — was achieved by 35.1% of participants in the Vuity group vs. 7.8% in the placebo group (P < .0001), according to company correspondence.
Headache and eye irritation were the most commonly reported adverse events, occurring in more than 5% of participants. Visual impairment, eye pain, blurred vision and vitreous floaters were reported in 1% to 5% of participants.
The FDA initially approved Vuity in 2021.
Editor’s note: This article was updated on April 4, 2023, to include comments from Sarika Sood.
Collapse
Press Release
Read more about
Click Here to Manage Email Alerts