Pilocarpine HCl Ophthalmic Solution 1.25% in Mild Presbyopia: Post Hoc Analysis of the GEMINI Phase 3 Trials

Abstract

Purpose : Purpose: In the multicenter, double-masked, randomized GEMINI studies, pilocarpine hydrochloride (HCl) ophthalmic solution 1.25% in a proprietary vehicle (Pilo) improved near vision, as well as reading performance and associated satisfaction per the validated Near Vision Presbyopia Task-based Questionnaire (NVPTQ). To further clinical decision making, this post hoc analysis evaluated outcomes in the participant subgroup with mild presbyopia (ie, photopic distance-corrected near visual acuity [DCNVA] 20/25-20/40 per published guidance from an expert panel).

Methods : Methods: GEMINI study participants (age, 40-55 y) had objective/subjective evidence of presbyopia and received Pilo or vehicle bilaterally, once daily (QD) for 30 days. Pooled data assessed the proportion of participants with mild presbyopia who gained ≥3 and ≥2 lines from baseline in mesopic high-contrast, binocular DCNVA at hour 1 (Pilo’s peak effect) on days 1, 7, 14, and 30. The least squares mean (LSM) change from baseline (CFB) in mesopic NVPTQ-based reading performance (0-5 scale) and satisfaction (0-4 scale) on day 14 hour 1 and day 30 hour 3 were also evaluated.

Results : Results: Of 750 participants (mean age, 49.7 y), 373 had mild presbyopia (age: mean, 49.1 y; range 40-55 y); 186 received Pilo and 187 received vehicle. In this subgroup, significantly more participants gained ≥3 and ≥2 lines in mesopic DCNVA with Pilo than vehicle at hour 1 on days 1, 7, 14 and 30 (Figure; all P≤.0048). The proportion of participants with ≥3- and ≥2-line gains peaked at day 30 and 14, respectively. On day 14 hour 1, the LSM (standard error) CFB in performance score was 1.7 (0.1) with Pilo vs 0.4 (0.1) with vehicle; the LSM CFB in satisfaction score was 1.5 (0.1) vs 0.4 (0.1), respectively (all P<.0001). On day 30 hour 3, the LSM CFB in performance score was 1.4 (0.1) with Pilo vs 0.5 (0.1) with vehicle; the LSM CFB in satisfaction score was 1.3 (0.1) vs 0.5 (0.1), respectively (both P≤.0075).

Conclusions : The proportion of participants with mild presbyopia and improvements in mesopic near vision 1 hour post-administration was significantly greater with Pilo QD than vehicle through day 30, with most improvement occurring by day 14. These findings were reflected in the significantly greater NVPTQ ratings, supporting Pilo use in mild presbyopia.

This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.

 

Participants (%) with Mild Presbyopia and Gains in Mesopic DCNVA at Hour 1