PR Newswire | Nov 8, 2021 08:30AM EST

Portfolio at the AAO (American Academy of Ophthalmology) 2021 Annual Meeting

11/08 07:30 CST

Allergan, an AbbVie Company, to Present New Data from its Leading Eye Care Portfolio at the AAO (American Academy of Ophthalmology) 2021 Annual Meeting NORTH CHICAGO, Ill., Nov. 8, 2021

NORTH CHICAGO, Ill., Nov. 8, 2021 /PRNewswire/ -- Allergan, an AbbVie (NYSE: ABBV) company, announced that it will present new pooled post-hoc analyses and patient-reported outcomes (PROs) of VUITYTM (pilocarpine HCl ophthalmic solution) 1.25%, newly approved by the FDA as the first and only eye drop to treat presbyopia; additional analyses on DURYSTA(r) (bimatoprost intracameral implant); and three real-world data studies on the glaucoma patient journey at the AAO (American Academy of Ophthalmology) 2021 Annual Meeting, November 12-15.

"The importance of improving visual function cannot be overstated, especially in the context of conditions such as presbyopia, which can have a significant effect on daily activities," said Michael R. Robinson, M.D., vice president, global therapeutic area head, eye care, AbbVie. "The research we will present at the AAO 2021 Annual Meeting reflects our ongoing commitment to innovation that can change how patients manage their conditions."

Roughly 128 million people, nearly half of the U.S. adult population, experience age-related blurry near vision or presbyopia, a common and progressive eye condition that reduces the eye's ability to focus on near objects and usually impacts people after age 40.

VUITY is the first and only FDA-approved eye drop to treat presbyopia, commonly known as age-related blurry near vision, in adults. VUITYis a daily, prescription eye drop that improves near and intermediate vision without impacting distance vision. Specifically designed for presbyopia, VUITY is an optimized formulation of pilocarpine, an established eye care therapeutic, delivered with pHast(tm) technology. The proprietary pHast(tm) technology allows VUITY to rapidly adjust to the physiologic pH of the tear film. VUITY uses the eye's own ability to reduce pupil size, improving near vision without affecting distance vision.

Researchers will also present data from an ongoing 24-month extension study of the Phase 3 ARTEMIS study assessing the efficacy and duration of DURYSTA. DURYSTA was approved by the FDA in March 2020 to reduce eye pressure (also called intraocular pressure, or IOP) in patients with open angle glaucoma (OAG) or high eye pressure (ocular hypertension, or OHT). Allergan has continued to further research DURYSTA to identify best use and practices in the clinical setting.

A complete listing of the Allergan AAO 2021 Annual Meeting abstracts can be viewed at https://registration.experientevent.com/showaao211/flow/Attendee#!/registrant//ShowItems/.

Details about Allergan's presentations are as follows:

Abstract Presentation Details All Times CST

Presbyopia

Session: OP06 - Refractive Original Papers PA031 - GEMINI 1 and GEMINI 2 Pooled Phase 3 Safety and Efficacy: AGN-190584 Primary and Key Secondary Sunday, November 14 Endpoints 9:45 - 9:52 a.m. Room: 255-257

Session: PT04 - Poster Theater: Refractive Surgery PO016 - Patient-Reported Outcomes in Pooled Phase 3 Studies of AGN-190584 (Pilocarpine 1.25%) for Saturday, November 13 Presbyopia 2:26 - 2:37 p.m. Room: Hall C

Glaucoma

Session: PT13 - Poster Theater: Glaucoma PO062 Real-World Survival of Medical Treatment Stability in OAG: A Multicenter, Retrospective Cohort Monday, November 15 Study 1:29 - 1:40 p.m. Room: Hall C

Session: PD05 - PO080 Extended Duration of IOP Lowering With Glaucoma Poster Bimatoprost Implant in a Phase 3 Clinical Trial Discussion On Demand Only

Session: OP07 - Glaucoma Original Papers PA038 - Health-Care Burden Following Laser Trabeculoplasty and iStent in U.S. Clinical Practice: Sunday, November 14 Medication Use and Subsequent Procedures 11:42 - 11:49 a.m. Room: 255-257

Session: PT02 - Poster Theater: Glaucoma PO010 Health-Care Resource Utilization After Saturday, November 13 Incisional Glaucoma Surgery in U.S. Clinical Practice 11:29 - 11:40 a.m. Room: Hall C

About PresbyopiaPresbyopia is caused by the loss of the eye's ability as it ages to focus on a near object. 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.

VUITY Use and Important Safety Information

USEVUITY(tm) (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 fullPrescribing Information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visitwww.fda.gov/medwatchor call 1-800-FDA-1088.

DURYSTA(r) Indications and Usage and Important Safety Information

Approved UsesDURYSTA(r) (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 INFORMATIONDURYSTA(r) 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(r) 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(r) more than once in each eye. DURYSTA(r) should be used with caution if you have a limited reserve of the cells lining the inner layer of the cornea.

DURYSTA(r) 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(r) may cause swelling of the macula, the center spot of the retina (back of the eye). DURYSTA(r) 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(r) may cause inflammation inside the eye or make existing inflammation worse.

DURYSTA(r) 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(r) administration.

The most common side effect involving the eyes reported in patients using DURYSTA(r) 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 atwww.Durysta.com.

About Allergan Eye CareAs 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 AbbVieAbbVie'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 StatementsSome 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 AbbVie