Abstract
Purpose :
This report presents results of a de novo, validated patient-reported outcomes instrument, the Presbyopia Impact and Coping Questionnaire (PICQ), in assessing effects of an optimized formulation of pilocarpine (1.25%; AGN-190584) on daily life, emotional impact and compensatory coping mechanisms in individuals with presbyopia.
Methods :
In this multicenter, double-masked, 30-day study (NCT03804268; n=323), individuals with presbyopia were randomized to bilateral treatment with AGN-190584 or vehicle (placebo) once daily. Secondary efficacy endpoints included mean change from baseline in PICQ Coping (8 item) and Impact (6 item) domain scores evaluating use of presbyopia coping behaviors or impacts on daily life during the past 7 days. In prespecified analyses of PICQ domain scores (Day 30 Hour 3 [3 hours after dosing]), the cumulative distribution of change scores from baseline was depicted and the proportion of responders to AGN-190584 (those achieving meaningful change threshold of ≥1 point reduction from baseline in PICQ domain scores) assessed.
Results :
Baseline PICQ Coping and Impact scores were generally comparable between treatment groups. At Day 30 Hour 3, the mean score differences (95% confidence interval [CI]) between groups for the Coping and Impact domain scores were -0.5 points (-0.6, -0.3) and -0.3 points (-0.4, -0.1), respectively (P=.011 for both vs vehicle). The cumulative proportion of participants reporting change in use of coping behaviors showed consistent separation between the two groups, favoring the AGN-190584 arm. Of the AGN-190584 group, 20.2% (95% CI: 10.5, 29.9; P<.001) more participants reported a ≥1 point reduction in PICQ Coping score vs vehicle. The difference in impact response rates was not significant.
Conclusions :
Analyses of PRO efficacy endpoints demonstrated significant improvement in participants’ subjective experiences with presbyopia. Participants who received AGN-190584 reported a clinically meaningful reduction in use of presbyopia coping mechanisms, versus participants receiving vehicle, supporting the value of this pharmacologic treatment option.
This is a 2021 ARVO Annual Meeting abstract.