ABBVIE INC.
Presbyopia, or age-related blurry near vision, can be diagnosed through a basic eye exam by an eye doctor (optometrist or ophthalmologist) and is a common and progressive eye condition that affects 128 million Americans, or nearly half of the
'We are pleased to be able to bring this first-of-its-kind treatment to market sooner than expected for the millions of Americans with presbyopia who may benefit from it,' said
'Many Americans deal with presbyopia, which typically begins around age 40, by relying on reading glasses or resorting to work-arounds like zooming in on their digital devices to see up close. As an optometrist who also has presbyopia, I'm personally and professionally excited to try VUITY for myself, as well as offer it to my patients with age-related blurry near vision,' said optometrist Dr.
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, improving near and intermediate vision while maintaining distance vision.
'As I've gotten older, my vision has changed, and it has become almost impossible to see clearly up close unless I wear my readers. Realizing that I needed to start using readers showed me how important it was to address this condition,' said
About the VUITY Clinical Development Program
The FDA approval of VUITY in
A total of 750 participants aged 40 to 55 years old with presbyopia were randomized in the two studies in a one-to-one ratio to either VUITY or placebo.
Participants were instructed to administer one drop of VUITY or placebo once daily in each eye.
Both studies met their primary endpoints with a statistically significant proportion of participants treated with VUITY gaining three lines (the ability to read three additional lines on a reading chart) or more in mesopic (in low light), high contrast, binocular Distance Corrected Near Visual Acuity (DCNVA), without losing more than 1 line (5 letters) of Corrected Distance Visual Acuity (CDVA) at day 30, hour 3, versus placebo.
There were no serious adverse events observed in any participants treated with VUITY in either clinical study. The most common adverse events occurring at a frequency of >5% in participants treated with VUITY were headache and eye redness.
About Presbyopia
Presbyopia, known as age-related blurry near vision, is a common and progressive eye condition that reduces the eye's ability to focus on near objects and usually impacts people after age 40. In a non-presbyopic eye, the clear lens behind the iris can change shape and focus light to the retina, making it easier to see things up close. In a presbyopic eye, the clear lens hardens and does not change shape as easily, making it difficult to focus on near objects. Presbyopia can be diagnosed by an eye doctor (ophthalmologist/optometrist).
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
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words 'believe,' 'expect,' 'anticipate,' 'project' and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefits from AbbVie's acquisition of
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Email: lisa.kim@abbvie.com
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