Twice daily pilocarpine HCI eye drops improve age related presbyopia: Phase 3 VIRGO trial

NORTH CHICAGO: New Phase 3 VIRGO trial data evaluating the safety and efficacy of pilocarpine HCI ophthalmic solution 1.25% (VUITY) in adults with age-related presbyopia and meeting its primary efficacy endpoint has been reported.

Allergan, an AbbVie (NYSE: ABBV) company, today announced that the Phase 3 VIRGO trial evaluating the safety and efficacy of investigational twice-daily administration of VUITY™ (pilocarpine HCl ophthalmic solution) 1.25% in adults with presbyopia met its primary efficacy endpoint, improving near vision without compromising distance vision at Hour 9 (3 hours after the second drop) on Day 14. Additional details of this trial will be presented at future medical congresses and will serve as the basis for a supplemental New Drug Application submission for an optional twice-daily administration to the U.S. Food and Drug Administration (FDA) in the second quarter of 2022. Approved by the FDA in October 2021 for once-daily use, VUITY is the first and only eye drop to treat age-related blurry near vision in adults.

"We are encouraged by the results from the VIRGO trial, which suggest that administering VUITY twice daily may provide an additional dosing option for people with presbyopia to improve their near vision without compromising their distance vision," said Christopher Lievens, O.D., clinical trial investigator and professor, Southern College of Optometry. "With similar safety results compared to the previous studies evaluating once-daily administration, VUITY administered twice daily may offer more flexibility in how blurry near vision is managed."