Allergan Announces Positive Data from Phase 3 GEMINI Trials Evaluating AGN-190584 for Presbyopia

Allergan Announces Positive Data from Phase 3 GEMINI Trials Evaluating AGN-190584 for Presbyopia

Allergan, an AbbVie company, announced positive topline results from the Phase 3 GEMINI 1 and 2 clinical trials evaluating the efficacy, safety and tolerability of AGN-190584 (pilocarpine 1.25%) ophthalmic solution for the treatment of symptoms associated with presbyopia. Both trials met their primary efficacy endpoint. Additional details of these studies will be presented at future medical meetings and will serve as the basis for the New Drug Application submission to U.S. Food and Drug Administration (FDA) in the first half of 2021.

The identical GEMINI 1 and 2 trials enrolled a total of 750 patients who were randomized in a one-to-one ratio of placebo to AGN-190584 (pilocarpine 1.25%). AGN-190584 was administered bilaterally, once-daily, for 30 days. The primary endpoint was the proportion of patients gaining three lines (the ability to read three additional lines on a reading chart) or more in mesopic (in low light), high contrast, binocular Distance Corrected Near Visual Acuity (DCNVA) at Day 30, Hour 3 versus placebo. In both GEMINI trials the primary endpoint was met with statistical significance over placebo. The majority of secondary endpoints were also met in both stu...

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