– Seven abstract presentations showcase ongoing research in presbyopia and glaucoma

NORTH CHICAGO, Ill.April 28, 2022 /PRNewswire/ — Allergan, an AbbVie (NYSE: ABBV) company, announced that it will present new data on VUITY™ (pilocarpine HCl ophthalmic solution) 1.25%, the first and only FDA-approved eye drop for the treatment of presbyopia (age-related blurry near vision) in adults, and DURYSTA® (bimatoprost intracameral implant), a first-of-its-kind biodegradable implant to lower eye pressure for glaucoma patients, at the 2022 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting, May 1-4 in Denver, CO.

“The variety of data we will present will shed light on our continued commitment to innovate in the areas of presbyopia and glaucoma. We are looking forward to unveiling important studies on both VUITY and DURYSTA to show the advances we are making for those living with these conditions,” said Michael R. Robinson, M.D., vice president, global therapeutic area head, ophthalmology, AbbVie.

At the meeting, researchers will present new data on VUITY, a once-daily, prescription eye drop that improves near and intermediate vision without compromising distance vision in patients with age-related blurry near vision. The presentation data will include results from the GEMINI studies on pupil size, depth of focus, and duration of efficacy among other important trial outcomes. Presbyopia is a common and progressive eye condition that reduces the eye’s ability to focus on near objects. It usually impacts people after age 40, affecting approximately 128 million Americans or nearly half of the U.S. adult population.

In addition, attendees will learn of new research findings on DURYSTA. The presentation will focus on the duration of intraocular pressure (IOP) control following DURYSTA administration.

A complete listing of the Allergan ARVO 2022 Annual Meeting abstracts can be viewed at: https://arvo2022.arvo.org/abstracts.

Details about Allergan’s presentations are as follows:

Abstract

Linked to ARVO program

Presentation Details

All Times EDT

Presbyopia

Plasma pharmacokinetics of pilocarpine in participants administered VUITY (pilocarpine HCl ophthalmic solution) 1.25%

Session: IOLs and Presbyopia

Monday, May 2, 2022

2:30 PM to 4:30 PM

Posterboard Number: 1808 – F0424

Optimal pupil size for near-vision improvement without distance-vision loss in the GEMINI studies of AGN-190584 in presbyopia

Session: IOLs and Presbyopia

Monday, May 2, 2022

2:30 PM to 4:30 PM

Posterboard Number: 1810 – F0426

Corneal Permeability of Pilocarpine HCl 1.25% with Varying pH Formulations

Session: IOLs and Presbyopia

Monday, May 2, 2022

2:30 PM to 4:30 PM

Posterboard Number: 1814 – F0430

Extended Depth of Focus from AGN-190584 in GEMINI 1 and GEMINI 2 Pooled Phase 3 Studies

Session: IOLs and Presbyopia

Monday, May 2, 2022

2:30 PM to 4:30 PM

Posterboard Number: 1812 – F0428

No Impact of Headache or Visual Impairment Adverse Events following AGN-190584 Observed on Patient Reported Outcomes

Session: IOLs and Presbyopia

Monday, May 2, 2022

2:30 PM to 4:30 PM

Posterboard Number: 1815 – F0431

Duration of Efficacy of AGN-190584 on Photopic Distance-Corrected Intermediate Visual Acuity in the GEMINI 1 and GEMINI 2 Pooled Phase 3 Studies

Session: IOLs and Presbyopia

Monday, May 2, 2022

2:30 PM to 4:30 PM

Posterboard Number: 1811 – F0427

Glaucoma

Longevity of IOP Control Post Single Bimatoprost Implant Injection in a Phase 3b Study

Session: Clinical Studies and Trials
Wednesday, May 4, 2022

12:34 PM to 12:51 PM

Room 601/603 Denver Convention Center

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.

VUITY 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 or call 1-833-MY-VUITY.

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.

DURYSTA® Consumer Indications and Usage and Important Safety Information

Approved Uses
DURYSTA® (bimatoprost intracameral implant) is a prescription medicine to reduce eye pressure (also called intraocular pressure, or IOP) in patients with open angle glaucoma or high eye pressure (ocular hypertension).

IMPORTANT SAFETY INFORMATION
DURYSTA® should not be used if:

  • You have any infection or suspected infection in your eye or surrounding eye area
  • You have corneal endothelial cell dystrophy, a condition in which the clear front layer of your eye (cornea) has lost its ability to work normally and can cause vision problems
  • You have had a corneal transplant or cells transplanted to the inner layer of the cornea (endothelial cell transplant)
  • The sack that surrounds the lens of your eye (posterior lens capsule) is missing or torn
  • You are allergic to any of its ingredients

DURYSTA® may cause side effects involving the cornea, including increased risk of loss of cells from the inner layer of the cornea. You should not receive DURYSTA® more than once in each eye. DURYSTA® should be used with caution if you have a limited reserve of the cells lining the inner layer of the cornea.

DURYSTA® should be used with caution if you have narrow or obstructed iridocorneal angles (the space where the iris, the colored part of the eye, and cornea meet).

DURYSTA® may cause swelling of the macula, the center spot of the retina (back of the eye). DURYSTA® should be used with caution if your eye does not have a lens, if you have an artificial lens and a torn posterior lens capsule, or if you have any risk factors for swelling of the macula.

DURYSTA® may cause inflammation inside the eye or make existing inflammation worse.

DURYSTA® may cause increased brown coloring of the iris, which may be permanent.

Eye injections have been associated with infections in the eye. It is important that you contact your doctor right away if you think you might be experiencing any side effects, including eye redness, sensitivity to light, eye pain, or a change in vision, after an injection. Your doctor should monitor you following DURYSTA® administration.

The most common side effect involving the eyes reported in patients using DURYSTA® was eye redness. Other common side effects reported were: feeling like something is in your eye, eye pain, being sensitive to light, a blood spot on the white of your eye, dry eye, eye irritation, increased eye pressure, a loss of cells on the inner layer of the cornea, blurry vision, inflammation of the iris, and headache.

Please see full Prescribing Information available at www.Durysta.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.

If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more.

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 our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on TwitterFacebookInstagramYouTube 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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SOURCE AbbVie