Allergan, an AbbVie (NYSE: ABBV) company, 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.