'We look forward to sharing data from AGN-190584's Phase 3 study results with attendees at Academy 2021 that not only show an improvement in near vision in presbyopia patients, but also shed light on how practitioners may implement this treatment in the real world, pending approval,' said
Investigational AGN-190584 was specifically designed for the treatment of presbyopia. An optimized formulation of pilocarpine 1.25% with pHast technology was selected after the development of this proprietary vehicle and rigorous testing of 16 formulations. A New Drug Application was submitted to the
Abstracts for Academy 2021 can be viewed on the Academy website.
Posters are listed below and will be displayed all day
AGN-190584 Improves Intermediate Vision in Pooled Phase 3 Studies GEMINI 1 and 2; Comparison of Participants with and without LASIK in Near Vision Improvement with AGN-190584 Treatment; Near Vision Line Improvement Stratified by Baseline Severity with AGN-190584 in Pooled Phase 3 Studies GEMINI 1 and 2; Pooled Phase 3 GEMINI 1 and 2: AGN-190584 Improves Functional Near Vision; Interpreting Clinically Meaningful Near Vision Improvement in Presbyopia with AGN-190584 in the Gemini 1 Phase 3 Trial; GEMINI 1 and 2 Patient Experience with the Use of AGN-190584 (Pilocarpine 1.25%) for Presbyopia
About the Phase 3 Studies
GEMINI 1 and GEMINI 2 enrolled a total of 750 patients randomized in a one-to-one ratio of vehicle (placebo) to AGN-190584 (pilocarpine HCl ophthalmic solution 1.25%). Both studies met the primary endpoint, achieving statistical significance compared to vehicle in improvement in mesopic (low light) near vision on Day 30, Hour 3 without compromising distance vision. AGN-190584 was administered in each eye once-daily, for 30 days in both GEMINI 1 and GEMINI 2 participants with presbyopia. There were no treatment emergent serious adverse events observed in any AGN-190584 treated participants. The most common adverse reactions reported in >5% of patients were headache and conjunctival hyperemia. The majority of secondary endpoints were also met in both studies, including a significant improvement vs. vehicle in patient-reported outcomes (PROs) such as an increase in vision-related reading ability, and reductions in the impact of presbyopia on daily life and use of coping behaviors to manage presbyopia.
About AGN-190584
AGN-190584 is an investigational, novel optimized formulation of pilocarpine specifically designed for the treatment of presbyopia as a topical, once-daily drop delivered with pHast technology, a proprietary vehicle. This allows AGN-190584 to rapidly adjust to the physiologic pH of the tear film. The primary mechanism of action is through pupil constriction to improve near and intermediate vision while maintaining some pupillary response to different lighting conditions - an effect known as dynamic pupil modulation.
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 its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, LinkedIn or Instagram.
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