Allergan, an AbbVie (NYSE: ABBV) company, today announced that it will present new data from its leading portfolio of eye care medicines at the 2021 ASCRS (American Society for Cataract and Refractive Surgery) Annual Meeting being held July 23-27 in Las Vegas, NV. Presentations will include new data on AGN-190584 (pilocarpine 1.25%), an investigational presbyopia treatment, and updated analyses on DURYSTA(TM) (bimatoprost intracameral implant), the first and only FDA-approved dissolvable implant to reduce eye pressure in people with open angle glaucoma or high eye pressure.
"As a company, we remain committed to advancing care for difficult-to-treat eye conditions and diseases, such as presbyopia and glaucoma, that have a profound impact on daily life for millions of people," said Michael R. Robinson, M.D., vice president, global therapeutic area head, eye care, AbbVie. "Data presented at the 2021 ASCRS Annual Meeting will help us understand the potential for AGN-190584 to be a first-of-its-kind treatment option for those living with presbyopia, as well as augment our knowledge of DURYSTA, which has changed how physicians can care for patients with glaucoma."
Researchers will present new data evaluating the efficacy, safety and tolerability of investigational AGN-190584 for the treatment of presbyopia, inclusive of full data results from the Phase 3 GEMINI 1 study. GEMINI 1 data, in combination with data from the GEMINI 2 study, formed the basis of the AGN-190584 New Drug Application (NDA) currently under review with the U.S. Food and Drug Administration, which the agency is expected to act on by the end of 2021.
Updated analyses from the Phase 3 ARTEMIS studies assessing the efficacy and duration of DURYSTA will also be presented. 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 collect data to further understand how DURYSTA can best be used to benefit patients living with glaucoma.
A complete listing of the Allergan 2021 ASCRS Annual Meeting abstracts can be viewed at https://ascrs.confex.com/ascrs/21am/meetingapp.cgi/Home/0.
Details about Allergan's presentations are as follows:
Abstract Presentation Details Linked to ASCRS program All Times PDT Glaucoma Duration of IOP Lowering with Bimatoprost Implant and Profile of the IOP-Lowering Response before Rescue in the Phase 3 Artemis Studies Session: Minimally Invasive Glaucoma Surgery (MIGS) III Sunday, July 25 2:05 - 2:10 p.m. Room: MBCR - Level 2, Lagoon F Bimatoprost Implant for IOP Lowering: Responder Rates Overall and in Subgroups By Previous Medication Count in the Phase 3 Artemis Studies Session: Minimally Invasive Glaucoma Surgery (MIGS) III Sunday, July 25 2:10 - 2:15 p.m. Room: MBCR - Level 2, Lagoon F Efficacy of Intracameral Bimatoprost Implant in Patients Stratified By Baseline IOP (less-than or equal to 25 or >25 mmHg) in the Phase 3 Artemis Studies Session: Minimally Invasive Glaucoma Surgery (MIGS) III Sunday, July 25 2:20 - 2:25 p.m. Room: MBCR - Level 2, Lagoon F Presbyopia Gemini 1 Phase 3: AGN-190584 Improves Intermediate Vision in Participants with Presbyopia Session: Presbyopia Correcting IOL Comparisons, New Treatments and Studies Sunday, July 25 8:00 - 8:05 a.m. Room: MBCR - Level 2, Lagoon F Evaluating Vision-Related Reading Ability with a De Novo PRO Instrument in a Phase 3 Study of AGN-190584 (Pilocarpine 1.25%) for Presbyopia Session: Presbyopia Correcting IOL Comparisons, New Treatments and Studies Sunday, July 25 8:05 - 8:10 a.m. Room: MBCR - Level 2, Lagoon F Assessing Presbyopia Impacts and Coping Behaviors with De Novo PRO Instruments in a Phase 3 Study of AGN-190584 (Pilocarpine 1.25%) Session: Presbyopia Correcting IOL Comparisons, New Treatments and Studies Sunday, July 25 8:10 - 8:15 a.m. Room: MBCR - Level 2, Lagoon F Gemini 1 Phase 3: AGN-190584 Provides Rapid Improvement of Distance Corrected Near Vision That Is Maintained in Participants with Presbyopia Session: Presbyopia Correcting IOL Comparisons, New Treatments and Studies Sunday, July 25 8:15 - 8:20 a.m. Room: MBCR - Level 2, Lagoon F Gemini 1 Phase 3: Safety and Efficacy of AGN-190584 in Participants with Presbyopia Session: Presbyopia Correcting IOL Comparisons, New Treatments and Studies Sunday, July 25 8:25 - 8:30 a.m. Room: MBCR - Level 2, Lagoon F
*ASCRS Disclaimer: All educational content of the ASCRS ASOA Annual Meeting is planned by its program committee, and ASCRS ASOA does not endorse, promote, approve, or recommend the use of any products, devices, or services.
About AGN-190584AGN-190584 is an investigational, novel optimized formulation of pilocarpine specifically designed for the treatment of presbyopia, as a topical, once-daily drop delivered by a proprietary vehicle. The primary mechanism of action is through dynamic pupil modulation, an effect in which the pupil is constricted to achieve an optimal pupil size range while maintaining pupillary response to different lighting conditions. This allows for an increased depth of focus without compromising distance vision.
DURYSTA(TM) Consumer Indications and Usage and Important Safety Information
Approved UsesDURYSTA(TM) (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(TM) 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(TM) 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(TM) more than once in each eye. DURYSTA(TM) should be used with caution if you have a limited reserve of the cells lining the inner layer of the cornea.
DURYSTA(TM) 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(TM) may cause swelling of the macula, the center spot of the retina (back of the eye). DURYSTA(TM) 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(TM) may cause inflammation inside the eye or make existing inflammation worse.
DURYSTA(TM) 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(TM) administration.
The most common side effect involving the eyes reported in patients using DURYSTA(TM) 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 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, LinkedIn or Instagram.
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 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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