|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|
|By: PR Newswire Association LLC. - 25 Jul 2021||Back to overview list
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
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 Allergan Eye Care
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