April 19, 2022

Allergan, an AbbVie Company, to Present New Data from its Eye Care Portfolio at the 2022 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting

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- Seven abstract presentations reinforce leadership in eye care, including continued presbyopia and glaucoma treatment research

NORTH CHICAGO, Ill., April 19, 2022 /PRNewswire/ -- Allergan, an AbbVie (NYSE: ABBV) company, announced that it will present new data from its leading eye care portfolio at the 2022 American Society for Cataract and Refractive Surgery (ASCRS) Annual Meeting being held April 22 – 26 in Washington, D.C. Presentations will include new data on VUITYTM (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 XEN® Gel Stent, a surgical implant designed to lower high eye pressure, FDA-cleared for refractory glaucoma patients.

"The data we'll be presenting at ASCRS showcases our continued commitment to innovate and provide additional treatment options for patients with eye conditions like presbyopia and glaucoma," said Michael R. Robinson, M.D., vice president, global therapeutic area head, ophthalmology, AbbVie.

At the meeting, researchers will present new studies on the safety and efficacy of VUITY in a variety of settings. Notable data will include a post-hoc analysis evaluating the use of VUITY in participants with moderate to advanced presbyopia and a new analysis evaluating the onset of efficacy in participants with presbyopia. AbbVie will also present an analysis evaluating intermediate vision for presbyopia patients treated with VUITY.  

Additionally, new analyses from studies assessing the safety and efficacy of the XEN® Gel Stent will be presented. The XEN® Glaucoma Treatment System is indicated for the surgical management of refractory glaucoma, including cases where previous surgical treatment has failed; cases of primary open angle glaucoma; and pseudoexfoliative or pigmentary glaucoma with open angles that are unresponsive to maximum tolerated medical therapy. The XEN® Gel Stent is FDA-cleared for insertion via an ab interno approach; ab externo insertion of XEN® Gel Stent is investigational and the safety and efficacy of this approach have not been evaluated by the FDA.

A complete listing of the Allergan ASCRS 2022 Annual Meeting abstracts can be viewed at https://ascrs.confex.com/ascrs/22am/meetingapp.cgi/Home/0.

Details about Allergan's presentations are as follows:

Abstract

Linked to ASCRS program

Presentation Details

All Times ET

Presbyopia

GEMINI 1 & 2 Pooled Phase 3: The Proportion of
Subjects with Clinically Meaningful Near Vision
Improvement
 

Session: Presbyopia Correction – Outcomes/Comparisons

Saturday, April 23, 2022

10:15 – 10:20 AM

Room: WEWCC - Level 1, 143B

AGN-190584 and Rapid Visual Acuity Improvement
in Presbyopia on Day 1 of Treatment: Results from
the Phase 3 Studies

 

Session: Presbyopia Correction – Outcomes/Comparisons

Saturday, April 23, 2022

10:28 – 10:33 AM

Room: WEWCC - Level 1, 143B

GEMINI 1 & 2 Pooled Phase 3: The Evaluation of
Intermediate Vision for Presbyopia Patients Treated
with AGN-190584
 

 

Session: Presbyopia Correction – Outcomes/Comparisons

Saturday, April 23, 2022

10:23 – 10:28 AM

Room: WEWCC – Level 1, 143B

AGN-190584 Improves Photopic Distance
Corrected Near Vision in Participants with Mild to
Moderate Presbyopia: Results of the Phase 3 Studies
 

Session: Presbyopia Correction – Outcomes/Comparisons

Saturday, April 23, 2022

10:33 – 10:38 AM

Room: WEWCC - Level 1, 143B

AGN-190584 Improves Near and Intermediate
Vision in a Subgroup of Subjects with Moderate to
Advanced Presbyopia
 

Session: Presbyopia Correction: New Treatments and Studies

Monday, April 25, 2022

4:10 – 4:15 PM

Room: WEWCC - Level 1, 143C

Glaucoma

Randomized, Multicenter, 12-Month Evaluation of
Effectiveness and Safety of the Gel Stent Vs
Trabeculectomy: The Gold Standard Pathway Study

Session: Glaucoma – Procedures

Sunday, April 24, 2022

3:30 – 3:35 PM

Room: WEWCC – Level 1, 143C

12-Month Outcomes Of Ab-Externo Gel Stent
Placement In Eyes Naïve Vs Not Naïve To
Conjunctival-Incisional Glaucoma Surgery:
The EXPAND Study

Session: Glaucoma – Procedures

Sunday, April 24, 2022

3:58 – 4:03 PM

Room: WEWCC – Level 1, 143C

*ASCRS Disclaimer: All educational content of the ASCRS Annual Meeting is planned by its program committee, and ASCRS does not endorse, promote, approve, or recommend the use of any products, devices, or services.

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.

About XEN® Gel Stent 

INDICATIONS: The XEN® Glaucoma Treatment System is available for the surgical management of refractory glaucomas, including cases where previous surgical treatment did not work, cases of primary open-angle glaucoma, and cases of pseudoexfoliative or pigmentary glaucoma with open angles that are unresponsive to maximum tolerated medical therapy.

IMPORTANT SAFETY INFORMATION

Who should not receive the XEN® Glaucoma Treatment System? This surgical treatment should not be used if you currently have any of the following: angle-closure glaucoma where the drainage angle of the eye has not been surgically opened; a glaucoma drainage device previously implanted or scarring and pathologies of the conjunctiva (the clear membrane covering the white outer layer of the eye) in the area needed for this implant; eye inflammation (such as inflammation of the eyelids, conjunctiva, cornea, or uvea); abnormal formation of new blood vessels on the iris (the colored part of the eye) surface; artificial lens implanted in the anterior chamber (the space between your cornea, the outer transparent part of the eye, and the iris); silicone oil in your eye; and vitreous (the transparent jelly-like tissue that is found behind the lens) present in the anterior chamber.

What warnings should I be aware of? XEN® Gel Stent complications may include buildup of fluid between the choroid (inner layer of blood vessels) and the sclera (white outer layer of the eyeball), blood in the eye, very low eye pressure, implant moving to another part of the eye, implant exposure, wound leak, need for additional surgical intervention, and other eye surgery complications. The safety and effectiveness of the XEN® Gel Stent in neovascular, congenital, and infantile glaucoma has not been established. After the XEN® Gel Stent procedure, to help avoid the possibility of implant damage, avoid rubbing or pressing your fingers on the eye in the area where the XEN® Gel Stent was implanted.

What precautions should I be aware of? Before surgery, your doctor will check that the device and injector are not damaged. During surgery, your doctor will stop the procedure if he or she observes increased resistance during implantation and will use a new XEN® system. After surgery, your doctor should check and manage your eye pressure appropriately. The safety and effectiveness of implanting more than one XEN® Gel Stent in an eye has not been studied.

What are possible side effects? The most common side effects after surgery include reduction of vision, eye pressure becoming too low, an increase in eye pressure, and need for an additional surgical procedure in the eye to release scar tissue (needling) around the implant under the conjunctiva. Talk to your doctor about other possible side effects.

Caution: Federal law restricts this device to sale by or on the order of a licensed physician. Click here for full Directions for Use or call 1-800-678-1605. Please call 1-800-433-8871 to report an adverse event.    

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 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.

SOURCE AbbVie

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