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VUITY topline phase 3 results announced
Study evaluated twice-daily administration of VUITY (pilocarpine HCI ophthalmic solution) 1.25% in adults with age-related blurry near Vision
Allergan announced positive topline results from its ongoing VUITY trial, which evaluated the safety and efficacy of twice-daily VUITY for the treatment of mild to moderate presbyopia in adults.
In the VIRGO Phase 3 trial, 230 adults with presbyopia were randomly assigned to receive two drops of VUITY twice a day for 14 days.
The trial met its primary endpoint, which was improving near vision without compromising distance vision at hour 9 and 3 hours after the second drops, on day 14.
Additional details of the trial will be presented at medical congresses and submitted for approval of a twice-daily administration of VUITY in 2022.
The study also showed that a significant portion of participants gained 3 lines of vision.
The safety of the trial was similar to studies that have shown that once-daily administration of VUITY can improve near vision. However, the twice-daily use of VUITY is not approved by the FDA.
