New Data Presented on the Safety and Efficacy of Investigational AGN-190584 as a Potential Novel Treatment for Presbyopia, a Common and Progressive Eye Condition

Rhea-AI Summary

Allergan, a subsidiary of AbbVie (NYSE: ABBV), announced results from the Phase 3 GEMINI 1 study for AGN-190584, an investigational ophthalmic solution aimed at treating presbyopia. The study showed significant vision improvement without loss of distance vision, with 22.5% of participants achieving a three-line gain in near vision at three hours post-dose. AGN-190584 is under FDA review, expected to act by late 2021. The positive study outcomes highlight AGN-190584's potential as a first-line treatment for presbyopia, a progressive eye condition affecting 128 million Americans.

Positive

• Phase 3 GEMINI 1 study demonstrated significant near and intermediate vision improvement with AGN-190584.
• 22.5% of participants achieved a three-line gain in near vision at Day 30.
• No loss of distance vision observed in participants receiving AGN-190584.
• Rapid onset of effects (15 minutes) and sustained vision gains for up to six hours.
• FDA review of AGN-190584 New Drug Application expected to conclude by late 2021.

Negative

• Limited information on long-term efficacy and safety beyond the 30-day study period.

NORTH CHICAGO, Ill., July 25, 2021 /PRNewswire/ -- Allergan, an AbbVie (NYSE: ABBV) company, today announced new data, including the full results from the Phase 3 GEMINI 1 clinical study, evaluating the efficacy, safety and tolerability of investigational AGN-190584 (pilocarpine 1.25%) ophthalmic solution for the treatment of presbyopia.

Multiple data presentations at the 2021 ASCRS (American Society of Cataract and Refractive Surgery) Annual Meeting demonstrated that AGN-190584 met both its primary and key secondary efficacy endpoints with patients achieving near and intermediate vision gains. In addition, AGN-190584 showed no loss of distance vision, a rapid onset of action and sustained vision gains of up to six hours. Further details including additional efficacy and safety results are included in the "GEMINI 1 Study Results" section below.  

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. 

"Building upon our heritage in eye care, we are proud to be leading the development of a first-of-its-kind potential treatment option for those living with presbyopia. If approved by the FDA, AGN-190584 is expected to be the first eye drop specifically designed for presbyopia," said Michael R. Robinson, M.D., vice president, global therapeutic area head, eye care, AbbVie. "We are pleased with the favorable safety and efficacy results, as well as the rapid onset and duration of improvement in near and intermediate vision without impacting distance vision, from the Phase 3 GEMINI 1 clinical study."

Patient-reported outcomes presented at the meeting showed that patients who received AGN-190584 versus the vehicle (placebo) reported clinically meaningful and statistically significant greater improvement in ability and satisfaction related to near-vision reading as well as reduction in use of presbyopia coping mechanisms during the last seven days of the trial.

"Presbyopia is a common and progressive eye condition that makes it more difficult to focus on things up close and affects most adults over the age of 40. While not often known by name, the 128 million Americans living with presbyopia feel the condition's impact throughout their daily lives, often when looking at their cell phones, reading or trying to see a menu in a dimly lit restaurant. Additionally, our ever-increasing time spent on digital devices, from smart watches to smart phones, has put unprecedented demands on our vision," said George O. Waring IV, M.D., FACS, medical director, Waring Vision Institute, South Carolina, and GEMINI principal study investigator. "The positive GEMINI 1 findings support the potential of AGN-190584 as a first-line option for people living with presbyopia."

Presbyopia is caused by the loss of the eye's ability to focus on a near object. In a non-presbyopic eye, the clear lens behind the iris can change shape and focus light to the retina, making it easier to see things up close. In a presbyopic eye, the clear lens hardens and does not change shape as easily, making it difficult to focus on near objects. AGN-190584 is an investigational eye drop designed to treat presbyopia and is instilled in both eyes, once daily.

GEMINI 1 Study Results
The GEMINI 1 clinical study evaluated 323 participants randomized in a one-to-one ratio of vehicle (placebo) to AGN-190584 (pilocarpine 1.25%). AGN-190584 was instilled bilaterally (in both eyes), once daily, for 30 days in GEMINI 1 participants with presbyopia. The primary and key secondary endpoints were met with a statistically significant greater proportion of participants treated with AGN-190584 who gained three lines or more (the ability to read three additional lines on a reading chart) in mesopic (in low light), high contrast, binocular Distance Corrected Near Visual Acuity (DCNVA) at Day 30, Hour 3 (22.5%, p < 0.0001) and Hour 6 (9.7%, p = 0.0114) versus the vehicle. The results demonstrated AGN-190584 had a rapid onset of 15 minutes and duration of up to six hours in mesopic DCNVA without loss of distance vision after administration at Day 30. Additional endpoints evaluated showed that 75% of participants treated with AGN-190584 achieved a ≥2-line improvement in mesopic DCNVA; and 93% of participants achieved ≥20/40 vision in photopic (daylight) DCNVA. Improvements were also observed in Distance Corrected Intermediate Visual Acuity (DCIVA) for up to 10 hours at Day 30.

There were no treatment emergent serious adverse events observed in any AGN-190584 treated participants. The most common treatment emergent non-serious adverse event in AGN-190584 treated participants occurring at a frequency of >5% was headache. Most side effects were mild and transient in nature with only 1.2% of patients discontinuing due to adverse events.

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 by a proprietary vehicle. The primary mechanism of action is through pupil constriction to enhance depth of focus and improve near and intermediate vision while maintaining 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.

*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 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.

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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SOURCE AbbVie

FAQ

What were the results of the ABBV AGN-190584 study presented on July 25, 2021?

The ABBV AGN-190584 study showed significant improvements in near vision, with 22.5% of participants gaining three lines at three hours post-dose. No loss of distance vision was reported.

When is the FDA expected to act on ABBV's AGN-190584 submission?

The FDA is expected to conclude its review of the AGN-190584 New Drug Application by the end of 2021.

What condition does AGN-190584 target?

AGN-190584 is aimed at treating presbyopia, a progressive eye condition affecting many adults over 40.

What is the significance of the GEMINI 1 study for ABBV?

The GEMINI 1 study's positive results support the potential of AGN-190584 as a first-line treatment option for presbyopia, which is significant for ABBV's eye care portfolio.