Abstract
Purpose :
In the double-masked, randomized, controlled, phase 3 GEMINI studies, presbyopes receiving pilocarpine hydrochloride (HCl) ophthalmic solution 1.25% in a proprietary vehicle (Pilo hereafter) demonstrated a gradual increase in depth of focus (DOF) over 30 days. This post hoc analysis evaluated DOF in participant subgroups with mild or moderate presbyopia (ie, photopic distance-corrected near visual acuity [DCNVA] 20/25-20/40 and 20/50-20/80, respectively, per published guidance from an expert panel) to further guide clinical decision making.
Methods :
The GEMINI study participants (40-55 years) had objective/subjective evidence of presbyopia and used Pilo or vehicle bilaterally, once daily for 30 days. Pooled data assessed the changes in DOF (per a phoropter) and pupil size from baseline at Hour 1 post-instillation in the dominant eye on days 1, 3, 7, 14, and 30 in the aforementioned subgroups.
Results :
Of 750 randomized participants, 373 had mild presbyopia (Pilo, N=186; vehicle, N=187) and 319 had moderate presbyopia (Pilo, N=159; vehicle, N=160). On days 1, 3, 7, 14, and 30 in the mild presbyopia subgroup, the mean DOF change from baseline was 0.45, 0.45, 0.58, 0.68, and 0.82 D with Pilo vs 0.09, 0.10, 0.15, 0.16, and 0.18 D with vehicle, respectively. In the moderate presbyopia subgroup, the mean DOF change from baseline was 0.44, 0.55, 0.57, 0.67, and 0.63 D with Pilo vs 0.11, 0.12, 0.11, 0.20, and 0.22 D with vehicle, respectively. On days 1, 3, 7, 14, and 30 in the mild presbyopia subgroup, the mean photopic pupil diameter change from baseline was -1.17, -1.03, -1.04, -1.22, and -1.18 mm with Pilo vs -0.06, -0.02, -0.04, -0.11, and -0.09 mm with vehicle, respectively. In the moderate presbyopia subgroup, the mean photopic pupil diameter change from baseline was -1.34, -1.26, -1.23, -1.37, and -1.39 mm on days 1, 3, 7, 14, and 30 with Pilo vs -0.05, -0.03, -0.03, -0.11, and -0.11 mm with vehicle, respectively.
Conclusions :
In both mild and moderate presbyopia, DOF increased until at least day 14, while the reduction in pupil diameter was stable from day 1 to 30 (Figure). These findings support Pilo use in both subgroups and may suggest a neuroadaptation response similar to that observed with Extended Depth of Focus Intraocular Lenses.
This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.