Additional details of these studies will be presented at future medical meetings and will serve as the basis for the New Drug Application submission to
In GEMINI 1, the primary endpoint was met with a statistically significant greater proportion of participants treated with AGN-190584 who gained three lines (the ability to read three additional lines on a reading chart) or more in mesopic (in low light), high contrast, binocular Distance Corrected Near Visual Acuity (DCNVA) at Day 30, Hour 3 versus the vehicle (placebo). In GEMINI 2, the primary endpoint was also met with a statistically significant greater proportion of participants treated with AGN-190584 who gained three lines or more in mesopic, high contrast, binocular DCNVA without loss of greater than five letters in Corrected Distance Visual Acuity (CDVA) with the same refraction at Day 30, Hour 3 versus the vehicle.
Roughly 128 million people in the
'Presbyopia symptoms can significantly disrupt everyday activities like reading, using a smartphone, working, and cooking,' said George O. Waring IV, M.D., FACS, medical director,
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 symptoms of presbyopia and is instilled in both eyes.
'Our research shows that the symptoms associated with presbyopia can significantly impact people's daily lives,' said
About the Studies
GEMINI 1 and 2 enrolled a total of 750 patients randomized in a one-to-one ratio of vehicle (placebo) to AGN-190584 (pilocarpine 1.25%). AGN-190584 was administered bilaterally, once-daily, for 30 days in both GEMINI 1 and 2 participants with presbyopia. In the GEMINI studies, AGN-190584 demonstrated significant near vision gains in mesopic (in low light) conditions without a loss of distance vision. 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 3% in AGN-190584 treated participants were headache, conjunctival hyperaemia, vision blurred, and eye pain. In both studies, the primary endpoint was met. The majority of secondary endpoints were also met in both studies, including a significant improvement 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 optimized formulation of pilocarpine, a cholinergic muscarinic receptor agonist, that is being investigated for treating symptoms associated with presbyopia as a topical, once-daily drop delivered by a proprietary vehicle.
The proposed mechanism of action of AGN-190584 is through dynamic pupil modulation, an effect in which the iris sphincter is contracted to achieve pupil size reduction in an optimal range. The goal of this pupil size reduction is to increase depth of focus. Secondarily, it is believed to allow for increased accommodation through mild contraction of the ciliary muscle.
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 new 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.
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
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