Eye Drop for the Treatment of Presbyopia

 Allergan announced that it has submitted a new drug application to the FDA 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 is expected to be the first eye drop for the treatment of presbyopia by the FDA. 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.

AGN-190584 is an investigational optimized formulation of pilocarpine, a cholinergic muscarinic receptor agonist, which activates the iris sphincter muscle and ciliary muscle. The proposed mechanism of action is through constricting the pupil to enhance the depth of focus. AGN-190584 also contracts the ciliary muscle, facilitating accommodation.