Allergan 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, according to a company press release.
The application was based on data from 2 phase 3 trials involving 750 patients randomized to receive AGN-190584 or placebo. AGN-190584 met the primary endpoint reaching statistical significance in improvement in near vision in mesopic conditions without a loss of distance vision versus the vehicle in both studies. No treatment emergent serious adverse events were observed, and the most common treatment emergent non-serious adverse events were headache and conjunctival hyperemia.
“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 in the press release. “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.”
Read the full press release here.
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