Allergan Submits New Drug Application to FDA for Investigational Treatment of Presbyopia

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NORTH CHICAGO, Ill.—Allergan, an AbbVie (NYSE: ABBV) company, has announced that it submitted a New Drug Application to the 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. If approved, this eye drop is expected to be the first eye drop to treat presbyopia, according to the recent announcement. 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 proposed mechanism of action of AGN-190584 is through contraction of the iris sphincter muscle, constricting the pupil to enhance the depth of focus and improve near and intermediate visual acuity while maintaining some pupillary response to light. AGN-190584 also contracts the ciliary muscle, facilitating accommodation.

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 treated participants, according to the Allergan announcement.