NORTH CHICAGO, Ill., February 24, 2022 – Allergan, an AbbVie (NYSE: ABBV) company, today announced new data to be presented from Allergan’s leading portfolio of eye care treatments at the 2022 American Glaucoma Society (AGS) Annual Meeting being held in Nashville, TN and virtually from March 3-6. Presentations will include updated analyses that help further scientific understanding of DURYSTA® (bimatoprost intracameral implant), as well as new data on the XEN® Gel Stent. The DURYSTA data presentations coincide with the two-year anniversary of the U.S. Food and Drug Administration (FDA) approval of this first-of-its-kind eye pressure lowering treatment for glaucoma patients in March 2020.
“Glaucoma is one of the primary causes of irreversible vision loss and blindness worldwide. We are proud of our portfolio that provides treatments to glaucoma patients at different stages of their disease, but know there is still work to be done,” said Michael R. Robinson, M.D., vice president, global therapeutic area head, eye care, AbbVie. “At AGS 2022 we will build on the growing body of knowledge around DURYSTA two years after its FDA approval, and present additional data about XEN investigating potential new uses of the gel stent that may improve glaucoma patient outcomes.”
Data to be presented include a new study comparing the efficacy and safety of the XEN Gel Stent to trabeculectomy, as well as data from the EXPAND study evaluating the real-world effectiveness and safety of a novel investigational placement of the stent. The XEN Gel Stent is FDA-cleared only for ab-interno placement.
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, or intraocular pressure (IOP), in patients with open angle glaucoma (OAG) or high eye pressure (ocular hypertension, or OHT). Findings from a study documenting DURYSTA’s impact on IOP over a 24-hour period will also be presented at the meeting.
A complete listing of the Allergan abstracts that are scheduled to be presented at the 2022 AGS Annual Meeting can be viewed at https://www.xcdsystem.com/ags/program/S9oEr0i/index.cfm.
Details about Allergan’s presentations are as follows:
Presentation Details All Times CST
|Prospective, Randomized, Multicenter, Open-label, 12-Month Evaluation of the Effectiveness and Safety of XEN45 vs Trabeculectomy: the Gold Standard Pathway Study (GPS)||Session: Top Posters Virtual Presentation with Q&ASaturday, March 57:00 – 8:30 a.m.|
|Bimatoprost Implant Effects on 24-Hour Intraocular Pressure||Session: Top Posters Virtual Presentation with Q&A Saturday, March 57:00 – 8:30 a.m.|
|Retrospective, multicenter, real-world evaluation of ab-externo gel stent placement: 12-month data from the EXPAND Study||Session: Top Posters Virtual Presentation with Q&A Saturday, March 57:00 – 8:30 a.m.|
|Extended Duration of IOP Lowering with Bimatoprost Implant in a Phase 3 Extension Study||Session: Paper Presentations: Treatment – Live Q&A*Note: Presentation pre-recorded and available on demandSaturday, March 59:00 – 9:40 a.m.Summit Ballroom|
DURYSTA® Consumer Indications and Usage and Important Safety Information
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.
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.
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 of the Allergan acquisition, failure to promptly and effectively integrate Allergan’s businesses, significant transaction costs and/or unknown or inestimable liabilities, potential litigation associated with the Allergan acquisition, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. 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 (SEC). 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.