Nov. 18, 2020
Allergan, an AbbVie company, announced that the Phase 3 GEMINI 1 and 2 clinical trials, evaluating the efficacy, safety and tolerability of investigational AGN-190584 (pilocarpine 1.25 percent) ophthalmic solution for the treatment of symptoms associated with presbyopia, met their primary efficacy endpoint.
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 U.S. Food and Drug Administration (FDA) in the first half of 2021.
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 three 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 three versus the vehicle.
Roughly 128 million people in the U.S. experience presbyopia. Results from a survey of 1,339 respondents, age 40-55, found that 90 percent were frustrated or irritated with presbyopia.
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“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, Waring Vision Institute in South Carolina. “While individuals currently have several options to help manage presbyopia, including glasses, contact lenses and surgery, research has shown that the majority of presbyopic individuals are frustrated with the use of contact lenses or glasses. These GEMINI findings support the possibility of another treatment option for people living with presbyopia.”
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 Michael R. Robinson, MD, vice-president, global therapeutic area head, ophthalmology, AbbVie. “The positive results from the GEMINI studies show the potential of this investigational optimized formulation of pilocarpine 1.25 percent to treat symptoms associated with presbyopia.”
