– Presbyopia, or age-related blurry near vision, is a common, progressive condition that reduces the eye’s ability to focus on near objects, affecting most adults over the age 40
– Phase 3 clinical studies demonstrated VUITY works in as early as 15 minutes and lasts for up to 6 hours, as measured on day 30, to improve near and intermediate vision without impacting distance vision
– Allergan, an AbbVie company, continues legacy of eye care innovation with VUITY, a first-of-its-kind FDA-approved treatment for presbyopia
Allergan, an AbbVie ( company, moment blazoned theU.S. Food and Drug Administration (FDA) blessing of VUITY ™ (pilocarpine HCl ophthalmic result)1.25 for the treatment of diplopia, generally known as age- related vague near vision, in grown-ups. VUITY is the first and only FDA-approved eye drop to treat this common and progressive eye condition that affects 128 million Americans, nearly half of theU.S. adult population.
” Utmost grown-ups manage with diplopia, or difficulty with near vision, as we progress. Beginning around the age of 40, numerous find themselves using reading spectacles, holding textbook further down, or indeed adding the fountain size and lighting on defenses to try to see more easily,” said Michael Severino,M.D., vice president and chairman, AbbVie.”We’re proud to offer VUITY as a first-of-its- kind formerly-diurnal eye drop that we believe will change the way people and their eye croakers approach diplopia. The FDA blessing of VUITY exemplifies our uninterrupted pursuit of innovative new treatments that push the boundaries of what is possible in eye care.”
VUITY is a daily, tradition eye drop that works in as early as 15 twinkles and lasts over to 6 hours, as measured on day 30, to ameliorate near and intermediate vision without impacting distance vision. Specifically designed for diplopia, VUITY is an optimized expression of pilocarpine, an established eye care remedial, delivered with pHast ™ technology. The personal pHast ™ technology allows VUITY to fleetly acclimate to the physiologic pH of the gash film. VUITY uses the eye’s own capability to reduce pupil size, perfecting near vision without affecting distance vision.
“As we progress, the lenses of our eyes come less flexible, making it more delicate to concentrate on effects up near. VUITY offers a novel, safe, well- permitted and effective volition to current options for managing age- related vague near vision,” said GeorgeO. Waring IV,M.D., FACS, medical director, Waring Vision Institute, South Carolina, and GEMINI 1 and GEMINI 2 top study investigator.”I’m particularly encouraged by the rapid-fire onset of action and duration of efficacity for VUITY to ameliorate near and intermediate vision without impacting distance vision with one drop daily, particularly for those with mild to moderate diplopia.”
The FDA blessing of VUITY is grounded on data from two vital phase 3 clinical studies, GEMINI 1 and GEMINI 2, which estimated the efficacity, safety and tolerability of VUITY for the treatment of diplopia. In both studies, VUITY met the primary endpoint, reaching statistical significance in enhancement in near vision in low light (mesopic) conditions without a loss of distance vision versus the vehicle (placebo) on day 30 at hour 3. Also, enhancement was seen as early as 15 twinkles and lasted through 6 hours. There were no serious adverse events observed in actors entering VUITY in either the GEMINI 1 or GEMINI 2 study. The most common adverse events being at a frequence of> 5 were headache and eye greenishness.
Highlights from the Phase 3 GEMINI 1 & GEMINI 2 Clinical Studies
A aggregate of 750 actors progressed 40 to 55 times old with diplopia were randomized in the two studies in a one-to-one rate of placebo to VUITY.
Actors were instructed to administer one drop of VUITY or placebo formerly daily in each eye.
Both studies met their primary endpoints with a statistically significant proportion of actors treated with VUITY gaining three lines (the capability to read three fresh lines on a reading map) or further in mesopic (in low light), high discrepancy, binocular Distance Corrected Near Visual Acuity (DCNVA), without losing further 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 actors treated with VUITY in either clinical study. The most common treatment emergentnon-serious adverse events being at a frequence of> 5 in actors treated with VUITY were headache and eye greenishness.
About Presbyopia
Presbyopia, known as age- related vague near vision, is a common and progressive eye condition that reduces the eye’s capability to concentrate on near objects and generally impacts people after age 40. In anon-presbyopic eye, the clear lens behind the iris can change shape and concentrate light to the retina, making it easier to see effects up near. In a hypermetropic eye, the clear lens hardens and doesn’t change shape as fluently, making it delicate to concentrate on near objects. Presbyopia can be diagnosed by an eye croaker (ophthalmologist/ optometrist).
Approved Use and Important Safety Information
VUITY ™ (pilocarpine HCL ophthalmic result)1.25 is a tradition eyedrop to treat age- related vague near vision ( diplopia) in grown-ups.
About Allergan Eye Care
As a leader in eye care, Allergan has discovered, developed, and delivered some of the most innovative products in the assiduity for further than 70 times. Allergan has launched over 125 eye care products and invested billions of bones in treatments for the most current eye conditions including glaucoma, optical face complaint, and retinal conditions similar as diabetic macular edema and retinal tone occlusion.
About AbbVie
AbbVie’s charge is to discover and deliver innovative drugs that break serious health issues moment and address the medical challenges of hereafter. We strive to have a remarkable impact on people’s lives across several crucial remedial areas immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio.
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