Vuity Approval Expanded to Allow for Second Dose of Presbyopia Treatment

The Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Vuity (pilocarpine hydrochloride ophthalmic solution) to allow for a second dose of the treatment for presbyopia in adults.

The new dosing option allows for a second dose (1 additional drop in each eye) that may be administered 3 to 6 hours after the first dose. The sNDA approval was based on data from the 14-day, randomized, double-masked, vehicle-controlled VIRGO study (ClinicalTrials.gov Identifier: NCT04983589), which included 230 patients 40 to 55 years of age with presbyopia. Patients were randomly assigned 1:1 to receive 1 drop of Vuity or vehicle twice daily in each eye, with each dose administered 6 hours apart.

Results demonstrated that 35% of patients treated with Vuity met the primary endpoint gaining 3-lines or more in mesopic, high contrast, binocular distance corrected near visual acuity, without losing more than 1 line (5 letters) of corrected distance visual acuity with the same refractive correction on day 14 at hour 9 (3 hours after the second dose) compared with 8% of patients in the vehicle group (P <.01). 

The most common adverse reactions reported among patients receiving 2 doses of Vuity were headache and eye irritation. Ocular adverse reactions included visual impairment, eye pain, blurred vision, and vitreous floaters.

Vuity is supplied as a sterile ophthalmic solution containing pilocarpine hydrochloride 1.25%.