Positive topline phase III results evaluating investigational twice-daily administration of Vuity.
Positive topline phase III results evaluating investigational twice-daily administration of Vuity in adults with age-related blurry near vision (presbyopia).
Allergan, an AbbVie company, announced that the Phase III 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 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."
In the VIRGO Phase III trial, a total of 230 participants aged 40 to 55 years old with presbyopia were randomized in a one-to-one ratio of vehicle (placebo) to Vuity, receiving two drops in each eye per day for 14 days, with the second drop at Hour 6 (6 hours after the first drop). The study met its primary endpoint, showing a statistically significant proportion of participants treated with Vuity twice daily gained three lines (the ability to read three additional lines on a near vision chart) or more in mesopic (low light), high contrast, binocular Distance Corrected Near Visual Acuity (DCNVA) with no more than 5-letter loss in low light Corrected Distance Visual Acuity (CDVA) at Day 14, Hour 9 (3 hours after the second drop) versus the vehicle (placebo). The safety profile was similar to that observed in studies with once-daily administration of Vuity; the most common adverse events occurring at a frequency of greater than 5% were headache and eye irritation. The twice-daily use of Vuity is not approved and its safety and efficacy have not been evaluated by the FDA.
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