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
'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
In the VIRGO Phase 3 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 >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.
'We know that many people with age-related blurry near vision are interested in the potential use of VUITY beyond once-daily administration to help manage their condition,' said
About Presbyopia
An estimated 128 million people in the
About VUITY
VUITY is an optimized formulation of pilocarpine, an established eye care therapeutic, specifically designed to treat age-related blurry near vision. It is delivered with proprietary pHast technology, which allows VUITY to rapidly adjust to the physiologic pH of the tear film. This was studied in simulated tear film, and the clinical significance is unknown. VUITY uses the eye's own ability to reduce pupil size and improves near and intermediate vision without compromising distance vision.
About Allergan Eye Care
As a leader in eye care, Allergan has discovered, developed, and delivered some of the most innovative products in the industry for more than 70 years. Allergan has launched over 125 eye care products and invested billions of dollars in treatments for the most prevalent eye conditions including glaucoma, ocular surface disease, and retinal diseases such as diabetic macular edema and retinal vein occlusion.
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio.
Forward-Looking Statements
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