NORTH CHICAGO, Ill.,
Dec. 9, 2021 /PRNewswire/
-- Allergan, an AbbVie (NYSE: ABBV) company, today announced
that VUITY™ (pilocarpine HCl ophthalmic solution)
1.25%, the first and only eye drop approved by the U.S. Food
and Drug Administration (FDA) to treat presbyopia, is now available
by prescription in pharmacies nationwide. 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 U.S. adult population.
Experience the interactive Multichannel News Release here:
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"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 Jag
Dosanjh, senior vice president medical therapeutics, Allergan, an
AbbVie company. "This significant innovation in age-related eye
health reflects our commitment to advance vision care and expands
our leading portfolio of treatments for eye care providers and
their patients."
"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. Selina McGee, Fellow
of the American Academy of Optometry. "With VUITY now available, it
is a good time for those who experience age-related blurry near
vision to visit their eye doctor for an exam and to discuss their
options to manage this common condition."
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 Toni Wright, clinical trial participant. "It was
great to have the opportunity to participate in the clinical study
investigating a new potential treatment option. I'm so excited the
investigational treatment, which has been identified as VUITY, is
now approved and available as a treatment to manage age-related
blurry near vision."
For product information, visit www.VUITY.com and talk to an
eye care professional.
About the VUITY Clinical Development Program
The FDA approval of VUITY in October
2021 was 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.
- 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).
Approved Use and Important Safety Information
USE
VUITY™ (pilocarpine hydrochloride
ophthalmic solution) 1.25% is a prescription eye drop used to treat
age-related blurry near vision (presbyopia) in adults.
IMPORTANT SAFETY INFORMATION
- Do not use VUITY if you are allergic to any of the
ingredients.
- Use caution when driving at night or performing hazardous
activities in poor lighting.
- Temporary problems when changing focus between near and distant
objects may occur. Do not drive or use machinery if vision is not
clear.
- Seek immediate medical care if you experience any sudden vision
loss.
- If you wear contact lenses, they should be removed prior to
VUITY use. Wait 10 minutes after dosing before reinserting contact
lenses.
- Do not touch the dropper tip to any surface as this may
contaminate the contents.
- If more than one topical eye medication is being used, they
must be administered at least 5 minutes apart.
- The most common side effects are headache and eye redness.
These are not all the possible side effects of VUITY.
Please see full Prescribing
Information at www.VUITY.com.
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 Allergan, an AbbVie company