Allergan submits NDA for presbyopia-correcting drop
In this video, Glen Curran, vice president anterior segment U.S. for Allergan, discusses the unmet need a therapeutic drop for the correction of presbyopia could potentially fulfill.
Allergan has submitted a new drug application for its investigational presbyopia treatment and expects action on the NDA from the FDA by the end of the year.
The NDA for AGN-190584 (pilocarpine 1.25%) ophthalmic solution is based on data from two phase 3 studies, according to a press release. GEMINI 1 and GEMINI 2 evaluated efficacy, safety and tolerability of the solution.
“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.,” Tom Hudson, MD, senior vice president of research and development and chief scientific officer, AbbVie, said in the release.
In the studies, 750 subjects were randomly assigned 1:1 to receive AGN-190584 or placebo. In both studies, the drug met its primary endpoint of reaching statistically significant near vision improvement in low-light conditions without losing distance vision compared with placebo, the release said.
No treatment-emergent serious adverse events were reported, with the most common treatment-emergent nonserious adverse events including headache and conjunctival hyperemia, occurring in 5% or more of the subjects treated with AGN-190584.
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