NORTH CHICAGO, Ill.,
Oct. 29, 2021 /PRNewswire/
-- Allergan, an AbbVie (NYSE: ABBV) company, today announced
the U.S. Food and Drug Administration (FDA) approval of
VUITY™ (pilocarpine HCl ophthalmic solution)
1.25% for the treatment of presbyopia, commonly known as
age-related blurry near vision, in adults. 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 the
U.S. adult population.
"Most adults cope with presbyopia, or difficulty with near
vision, as we age. Beginning around the age of 40, many find
themselves using reading glasses, holding text further away, or
even increasing the font size and lighting on screens to try to see
more clearly," said Michael
Severino, M.D., vice chairman and president, AbbVie. "We are
proud to offer VUITY as a first-of-its-kind once-daily eye drop
that we believe will change the way people and their eye doctors
approach presbyopia. The FDA approval of VUITY exemplifies our
continued pursuit of innovative new treatments that push the
boundaries of what's possible in eye care."
VUITY is a daily, prescription eye drop that
works in as early as 15 minutes and lasts up to 6 hours, as
measured on day 30, to improve near and intermediate vision without
impacting distance vision. Specifically designed for presbyopia,
VUITY is an optimized formulation of pilocarpine, an
established eye care therapeutic, delivered with pHast™ technology.
The proprietary pHast™ technology allows VUITY to
rapidly adjust to the physiologic pH of the tear film. VUITY uses
the eye's own ability to reduce pupil size, improving near vision
without affecting distance vision.
"As we age, the lenses of our eyes become less flexible, making
it more difficult to focus on things up close. VUITY offers a
novel, safe, well-tolerated and effective alternative to current
options for managing age-related blurry near vision,"
said George O. Waring IV, M.D., FACS, medical director, Waring
Vision Institute, South Carolina,
and GEMINI 1 and GEMINI 2 principal study investigator. "I am
particularly encouraged by the rapid onset of action and duration
of efficacy for VUITY to improve near and intermediate vision
without impacting distance vision with one drop daily, particularly
for those with mild to moderate presbyopia."
The FDA approval of VUITY is based on data from two pivotal
phase 3 clinical studies, GEMINI 1 and GEMINI 2, which evaluated
the efficacy, safety and tolerability of VUITY for the
treatment of presbyopia. In both studies, VUITY met the primary
endpoint, reaching statistical significance in improvement in near
vision in low light (mesopic) conditions without a loss of distance
vision versus the vehicle (placebo) on day 30 at hour 3.
Additionally, improvement was seen as early as 15 minutes and
lasted through 6 hours. There were no serious adverse events
observed in participants receiving VUITY in either the GEMINI 1 or
GEMINI 2 study. The most common adverse events occurring at a
frequency of >5% were headache and eye redness.
Highlights from the Phase 3 GEMINI 1 & GEMINI 2 Clinical
Studies
- 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
of placebo to VUITY.
- 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 treatment emergent non-serious 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).
Approved Use and Important Safety Information
VUITY™ (pilocarpine HCL ophthalmic solution) 1.25% is a
prescription eyedrop to treat age-related blurry near vision
(presbyopia) in adults.
What is the most important information I should know about
VUITY™?
- Do not use VUITY™ if you are allergic to any of the
ingredients.
- Use caution with night driving or with hazardous activities
performed in low light conditions.
- Temporary difficulty in adjusting focus between near and
distance objects may occur. Do not drive or use machinery if vision
is not clear.
- Seek immediate medical care if any sudden vision loss
occurs.
- If you wear contact lenses, they should be removed prior to
VUITY™ use and can be reinserted 10 minutes after
dosing.
- Do not touch the dropper tip to any surface to help avoid
contamination.
- If more than one topical eye medication is being used, they
should be administered at least 5 minutes apart.
- The most common side effects are headache and eye redness.
Please see full Prescribing Information.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch or
call 1-800-FDA-1088.
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. For more
information about AbbVie, please visit us at www.abbvie.com.
Follow @abbvie on
Twitter, Facebook, Instagram, YouTube and
LinkedIn.
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 Allergan plc
("Allergan"), failure to promptly and effectively integrate
Allergan's businesses, competition from other products, challenges
to intellectual property, difficulties inherent in the research and
development process, adverse litigation or government action,
changes to laws and regulations applicable to our industry and the
impact of public health outbreaks, epidemics or pandemics, such as
COVID-19. Additional information about the economic, competitive,
governmental, technological and other factors that may affect
AbbVie's operations is set forth in Item 1A, "Risk Factors," of
AbbVie's 2020 Annual Report on Form 10-K, which has been filed with
the Securities and Exchange Commission, as updated by its
subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no
obligation to release publicly any revisions to forward-looking
statements as a result of subsequent events or developments, except
as required by law.
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SOURCE AbbVie