Allergan, an AbbVie Company, Submits New Drug Application for Investigational AGN-190584 for the Treatment of Presbyopia

- If approved, this is expected to be the first eye drop to treat presbyopia

- Presbyopia is a common, progressive condition that reduces the aging eye's ability to focus on near objects and affects nearly half of the adult U.S. population

- AGN-190584 met primary endpoint, reaching statistical significance in improvement in near vision without a loss of distance vision in two pivotal Phase 3 studies involving 750 patients

News provided by

AbbVie

Feb 25, 2021, 08:00 ET

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.

Approximately 128 million adults in the U.S. experience presbyopia, a common and progressive eye condition that reduces the eye's ability to focus on near objects and usually impacts people after age 40. Yet, compared to other eye-related conditions, there is a much lower awareness of presbyopia by name.

"Presbyopia is a significant source of frustration for most adults over age 40 who find current treatments inconvenient or invasive," said Tom Hudson, MD, 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 announced in October 2020, and additional details of these studies will be presented at upcoming medical meetings this year.

About 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.

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, 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, the failure to realize the expected benefits of AbbVie's acquisition of Allergan or to promptly and effectively integrate Allergan's business, 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 2019 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. 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.

SOURCE AbbVie