NORTH CHICAGO, Ill., Dec. 9, 2021 /PRNewswire/ -- Allergan, Inc., 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.
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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.
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 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.
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.
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