November 6, 2020

Allergan, an AbbVie company, to Share New Data at American Academy of Ophthalmology (AAO) 2020 Virtual

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– Paper presentation includes new Phase 2 efficacy data for an investigational treatment for presbyopia
– New data evaluating safety and effectiveness of DURYSTA™ (bimatoprost implant)
– Additional analysis of data from Phase 3 ARTEMIS studies sheds light on how glaucoma patients with different characteristics may respond to DURYSTA™
NORTH CHICAGO, Ill., Nov. 6, 2020 – Allergan, an AbbVie Company, today announced that it will present new data advancing scientific understanding of an intraocular pressure (IOP) lowering treatment in glaucoma and evaluating an investigational treatment for presbyopia at American Academy of Ophthalmology (AAO) 2020 Virtual (November 13-15).
 
“It is imperative that we continue our mission to push forward research that addresses unmet treatment needs and bring innovative medicines that potentially improve the lives of people living with eye conditions and diseases such as presbyopia and glaucoma,” said Michael Robinson, M.D., vice president, global therapeutic area head, ophthalmology, AbbVie. “This year at AAO 2020 Virtual, we’re proud to present new data for our IOP-lowering treatment DURYSTA™, which delivers a much-needed option for glaucoma patients challenged by topical drops, and our investigational AGN-190584 for the treatment of presbyopia, which demonstrates potential to treat disruptive symptoms of presbyopia.”
 
Data presented at the meeting will include an analysis examining the safety and efficacy of DURYSTA™ and a second analysis of data from the Phase 3 ARTEMIS studies that identify different characteristics of glaucoma patients who may respond after being treated with DURYSTA™. These studies will add to the body of data for DURYSTA™, an innovative treatment indicated to reduce IOP in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).
 
A real-world study that provides new insights on how people with glaucoma in the United Kingdom utilize available resources will also be available on the virtual meeting platform.
 
Additionally, a paper will be presented on a potential treatment for presbyopia from two Phase 2b studies, which were used to identify the optimal concentration for the proprietary treatment formulation of investigational AGN-190584 used in future studies. AbbVie recently announced positive Phase 3 results for AGN-190584 (pilocarpine 1.25%) ophthalmic solution.

Full text of all presentation abstracts can be accessed in the AAO 2020 Virtual meeting program. Those who have registered to attend AAO 2020 Virtual can view the data starting on Friday, November 13th.
 
Allergan will present:
 
  • Two Phase 2b Study Results for the Development of a Proprietary Formulation for the Treatment of Presbyopia (Session: PA039, Paper – Recorded)
    Presenting Author: Francis W Price Jr., M.D.
 
  • Real-World Burden in Five Major United Kingdom Glaucoma Services (Session: PO207, Scientific Poster)
    Presenting Author: Anthony P Khawaja, MBBS
 
  • Predictive Factors for Long-Term IOP Lowering After Bimatoprost Implant 10-μg Administration in Phase 3 ARTEMIS Studies (Session: PO176, Scientific Poster)
    Presenting Author: Albert S Khouri, M.D.
 
  • Single Administration of Intracameral Bimatoprost Implant 10 μg: IOP Lowering and Safety (Session: PO181, Scientific Poster)
    Presenting Author: Felipe A Medeiros, M.D.
 
 
About DURYSTA™
 
DURYSTA™ is a prostaglandin analog indicated for the reduction of IOP in patients with OAG or OHT.
 
DURYSTA™ is an ophthalmic drug delivery system for a single intracameral administration of a biodegradable implant containing 10 mcg bimatoprost. DURYSTA™ should not be re-administered to an eye that received a prior DURYSTA™. DURYSTA™ is preloaded into a single-use applicator to facilitate the administration of the biodegradable implant directly into the anterior chamber of the eye.
 
INDICATIONS AND USAGE
DURYSTA™ (bimatoprost implant) is indicated for the reduction of intraocular pressure (IOP) in patients with open angle glaucoma (OAG) or ocular hypertension (OHT).
 
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
DURYSTA™ is contraindicated in patients with: active or suspected ocular or periocular infections; corneal endothelial cell dystrophy (e.g., Fuchs' Dystrophy); prior corneal transplantation or endothelial cell transplants (e.g., Descemet's Stripping Automated Endothelial Keratoplasty [DSAEK]); absent or ruptured posterior lens capsule, due to the risk of implant migration into the posterior segment; hypersensitivity to bimatoprost or to any other components of the product.
 
WARNINGS AND PRECAUTIONS
The presence of DURYSTA™ implants has been associated with corneal adverse reactions and increased risk of corneal endothelial cell loss. Administration of DURYSTA™ should be limited to a single implant per eye without retreatment. Caution should be used when prescribing DURYSTA™ in patients with limited corneal endothelial cell reserve.
 
DURYSTA™ should be used with caution in patients with narrow iridocorneal angles (Shaffer grade < 3) or anatomical obstruction (e.g., scarring) that may prohibit settling in the inferior angle.
 
Macular edema, including cystoid macular edema, has been reported during treatment with ophthalmic bimatoprost, including DURYSTA™ intracameral implant. DURYSTA™ should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema.
 
Prostaglandin analogs, including DURYSTA™, have been reported to cause intraocular inflammation. DURYSTA™ should be used with caution in patients with active intraocular inflammation (e.g., uveitis) because the inflammation may be exacerbated.
 
Ophthalmic bimatoprost, including DURYSTA™ intracameral implant, has been reported to cause changes to pigmented tissues, such as increased pigmentation of the iris. Pigmentation of the iris is likely to be permanent. Patients who receive treatment should be informed of the possibility of increased pigmentation. While treatment with DURYSTA™ can be continued in patients who develop noticeably increased iris pigmentation, these patients should be examined regularly.
 
Intraocular surgical procedures and injections have been associated with endophthalmitis. Proper aseptic technique must always be used with administering DURYSTA™, and patients should be monitored following the administration.
 
ADVERSE REACTIONS
In controlled studies, the most common ocular adverse reaction reported by 27% of patients was conjunctival hyperemia. Other common adverse reactions reported in 5%-10% of patients were foreign body sensation, eye pain, photophobia, conjunctival hemorrhage, dry eye, eye irritation, intraocular pressure increased, corneal endothelial cell loss, vision blurred, iritis, and headache.
 
Please see link to full prescribing information
 
For more information about DURYSTA, visit http://www.DURYSTAhcp.com
 
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 new treatments for the most prevalent eye conditions including glaucoma, ocular surface disease, and retinal diseases such as diabetic macular edema and retinal vein occlusion. Our eye care pipeline includes 13 additional agents for multiple ocular conditions.
 
We remain steadfast in helping eye care providers deliver the best in patient care through innovative products and outreach programs.
 
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 its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.comFollow @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 2019 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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