AbbVie has announced that its potential first-of-its-kind treatment option for presbyopia, AGN-190584, has met the primary and secondary endpoints of a phase 3 trial.
Presbyopia is an inability to focus on near objects, affecting 128 million Americans — there is currently no treatment. AbbVie's phase 3 Gemini 1 study included 323 participants, half of whom received a placebo. The trial demonstrated that AGN-190584 met both its primary and key secondary efficacy endpoints with patients achieving near and intermediate vision gains. In addition, the treatment showed a rapid onset of action and sustained vision gains of up to six hours as well as caused no loss of distance vision.
AbbVie showcased the data for the eyedrops — which the company picked up in its recent acquisition of Allergan — at the 2021 American Society of Cataract and Refractive Surgery annual meeting.
The company submitted an NDA for the drug to the FDA this past February and anticipates the agency will act on the NDA by the end of 2021.
Read the press release