Abstract
Purpose :
An optimized formulation of pilocarpine (AGN-190584) was developed as a pharmacologic treatment for presbyopia. In a phase 3 efficacy and safety study, a new Patient Reported Outcome (PRO) instrument, the Near Vision Presbyopia Task-based Questionnaire (NVPTQ), was used to evaluate vision-related reading performance and associated satisfaction.
Methods :
In this multicenter, double-masked, 30-day study (NCT03804268; n=323), individuals with presbyopia were randomized to bilateral AGN-190584 or vehicle (placebo) once daily. Secondary efficacy endpoints included mean change from baseline in mesopic NVPTQ Performance (range: 0-5) and Satisfaction (range: 0-4) domain scores on 4 paper-based reading tasks at Day 30 Hour 3. Cumulative distribution of change scores was depicted (intent-to-treat population). Proportion of responders to AGN-190584 (participants achieving individual-level meaningful change thresholds of ≥0.75 and ≥1.00 point improvement from baseline in Performance and Satisfaction scores, respectively) at Day 30 Hour 3 (3 hours after dosing) was assessed.
Results :
At Day 30 Hour 3, statistically significant improvements from baseline in both scores were reported with AGN-190584 versus vehicle: the mean score difference (95% confidence interval [CI]) between groups was 0.8 (0.6, 1.1) in vision-related reading performance and 0.8 (0.5, 1.1) in associated satisfaction (P=.011 for each). The AGN-190584 group showed consistent separation in improvement compared with the group receiving vehicle. Of the AGN-190584 group, 24.0% (95% CI: 13.0, 34.9) and 26.8% (95% CI: 16.2, 37.5) more individuals reported improvements at individual-level meaningful change thresholds in mesopic Performance and Satisfaction scores, respectively (P<.001 for each), versus vehicle.
Conclusions :
Analyses of these PRO efficacy endpoints demonstrated significant treatment benefit in patient-centric outcomes in presbyopia. Participants who received AGN-190584 reported greater ability and satisfaction related to near-vision reading compared with participants receiving vehicle supporting the role of a pharmacologic treatment for this condition.
This is a 2021 ARVO Annual Meeting abstract.