NORTH CHICAGO, Ill.,Feb. 25, 2021/PRNewswire/ -- Allergan, an AbbVie (NYSE: ABBV) company, today announced that it has submitted a New Drug Application to the U.S. Food and Drug Administration for investigational AGN-190584 (pilocarpine 1.25%) ophthalmic solution for the treatment of presbyopia. The FDA is expected to act on the NDA by the end of 2021.
美国大约有1.28亿成年人经历了长老会，这是一种常见和渐进的眼部状况，可降低眼睛专注于近物体的能力，通常会在40岁以后影响人们。然而，与其他与眼睛有关的情况相比，人们的意识降低了得多。长老会的名字。
"Presbyopia is a significant source of frustration for most adults over age 40 who find current treatments inconvenient or invasive," said Tom医学博士哈德森, senior vice president, R&D, chief scientific officer, AbbVie. "If approved, AGN-190584 is expected to be the first eye drop to treat presbyopia, providing a novel option to those affected in the U.S."
The NDA is based primarily on data from two Phase 3 GEMINI 1 and GEMINI 2 clinical studies, which evaluated the efficacy, safety and tolerability of AGN-190584 (pilocarpine 1.25%). A total of 750 patients were randomized in a one-to-one ratio of vehicle (placebo) to AGN-190584. In both studies, AGN-190584 met the primary endpoint reaching statistical significance in improvement in near vision in mesopic (in low light) conditions without a loss of distance vision vs. the vehicle. There were no treatment emergent serious adverse events observed in any AGN-190584 treated participants. The most common treatment emergent non-serious adverse events occurring at a frequency of ≥5% in AGN-190584 treated participants were headache and conjunctival hyperemia.
The Phase 3 GEMINI 1 and GEMINI 2 top-line results were previously宣布in2020年10月，这些研究的其他细节将在今年即将举行的医疗会议上介绍。
关于AGN-190584
AGN-190584 is an investigational optimized formulation of pilocarpine, a cholinergic muscarinic receptor agonist, which activates muscarinic receptors located at smooth muscles such as the iris sphincter muscle and ciliary muscle and is being investigated for the treatment of presbyopia as a topical, once-daily drop delivered by a proprietary vehicle.
The proposed mechanism of action of AGN-190584 is through contraction of the iris sphincter muscle, constricting the pupil to enhance the depth of focus and improve near and intermediate visual acuity while maintaining some pupillary response to light. AGN-190584 also contracts the ciliary muscle, facilitating accommodation.
关于Allergan眼部护理
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.
关于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 atwww.worldcupnut.com/。Follow @abbvie onTwitter,Facebook,Instagram,YouTubeandLinkedIn。
前瞻性语句
本新闻稿中的某些陈述是或可以考虑到1995年《私人证券诉讼改革法》的前瞻性陈述。“相信”，“期望”，“预期”，“项目”和类似的表达方式，除其他外，通常确定前瞻性陈述。阿布维（Abbvie）警告说，这些前瞻性陈述受风险和不确定性的约束，这些陈述可能导致实际结果与前瞻性陈述中指示的结果有实质性差异。这种风险和不确定性包括但不限于未能实现Abbvie收购Allergan的预期收益，或迅速有效地整合Allergan的业务，对知识产权的挑战，其他产品的竞争，研究和开发中固有的困难，狗万正网地址过程，不利诉讼或政府行动，以及适用于我们行业的法律和法规的变更。关于Abbvie 2019年2019年2019年年度报告，有关ABBVIE运营的经济，竞争，政府，技术和其他可能影响Abbvie行动的因素的其他信息，该信息已向证券和证券提交。交易委员会，其季度报告对10-Q表格的季度报告进行了更新，并在其他文件中随后向美国证券交易委员会提交，以更新，补充或取代此类信息。Abbvie没有义务因随后的事件或发展而公开对前瞻性陈述进行公开修订，但法律要求除外。狗万正网地址
SOURCE AbbVie
