- VUITY is the first and only eye drop to treat presbyopia, or
age-related blurry near vision, in adults and is FDA-approved for
once-daily administration
- In the VIRGO trial evaluating twice-daily administration of
VUITY, the primary endpoint of improving near vision without
compromising distance vision at Day 14, Hour 9 was met
- Data from the VIRGO trial will be presented at upcoming
medical congresses and serve as the basis for a supplemental U.S.
New Drug Application submission in the second quarter of
2022
NORTH
CHICAGO, Ill., April 5,
2022 /PRNewswire/ -- Allergan, an AbbVie (NYSE: ABBV)
company, today announced that the Phase 3 VIRGO trial evaluating
the safety and efficacy of investigational twice-daily
administration of VUITY™ (pilocarpine HCl ophthalmic solution)
1.25% in adults with presbyopia met its primary efficacy endpoint,
improving near vision without compromising distance vision at Hour
9 (3 hours after the second drop) on Day 14. 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 U.S.
Food and Drug Administration (FDA) in the second quarter of 2022.
Approved by the FDA in October
2021 for once-daily use, VUITY is the first and only
eye drop to treat age-related blurry near vision in adults.
"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
Christopher Lievens, O.D., clinical
trial investigator and professor, Southern
College of Optometry. "With similar safety results compared
to the previous studies evaluating once-daily administration, VUITY
administered twice daily may offer more flexibility in how blurry
near vision is managed."
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 Michael R. Robinson, M.D., vice president,
global therapeutic area head, ophthalmology, AbbVie. "The results
of the VIRGO trial showcase our continued effort to innovate for
patients with age-related blurry near vision and commitment to
expanding our leading portfolio of treatments for eye care
providers and patients."
About Presbyopia
An estimated 128 million people in the U.S. experience
presbyopia or age-related blurry near vision, 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 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.
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, the
medicines 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 2021 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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