Abstract
Purpose :
When pupil size reduces, defocus blur and peripheral aberration decrease to improve vision, while diffraction blur increases and retinal illumination decreases to reduce vision. Since reduced pupil size might have a different impact on distance and near vision for people with presbyopia, this exploratory analysis investigated an optimal range of pupil size that improves near vision while minimally impacting distance vision, based on pooled data from individuals who received AGN-190584 for presbyopia in the GEMINI studies.
Methods :
The randomized, double-masked, multicenter, vehicle-controlled, phase 3 GEMINI 1 and GEMINI 2 studies (N=750 total) evaluated safety and efficacy of AGN-190584 (once daily ophthalmic formulation of pilocarpine HCl 1.25% optimized in a proprietary vehicle [now FDA-approved as Vuity™]) in individuals with presbyopia. At 8 prespecified timepoints on Day 30, distance corrected near visual acuity (DCNVA) at 40 cm, corrected distance visual acuity (CDVA) at 4 m, and pupil diameter for the nondominant eye (per Neuroptics’ pupillometer) were assessed in mesopic conditions (10-11 lux at target). Analyses were conducted on pupil size when individuals gained ≥3 lines in DCNVA or lost >5 letters in CDVA from baseline on Day 30, by pupil diameter (using measurements at all 8 timepoints).
Results :
At day 30 in individuals who received AGN-190584, a trend suggesting a negative correlation between the change in DCNVA from baseline and pupil size was noted; smaller pupil sizes produced greater DCNVA improvement, with 50.6% (n=40/79), 24.0% (n=116/483), 16.6% (n=63/379), and 12.4% (n=73/588) of individuals gaining ≥3 lines for pupil sizes ≤1.5 mm, >2 to ≤2.5 mm, >3 to ≤3.5 mm, and >4 mm, respectively. However, when the pupil size was ≤2 mm, mesopic CDVA appeared to become compromised, with 4.4% (n=11/250) and 10.7% (n=6/56) of individuals losing >5 letters in CDVA for pupil sizes >1.5 to ≤2.0 mm and ≤1.5 mm, compared with 2.1% (n=7/335), 1.7% (n=5/296), and 4.1% (n=20/483) for pupil sizes >2.0 to ≤2.5 mm, >3.0 to ≤3.5 mm, and >4 mm, respectively.
Conclusions :
An optimum pupil size should consider both NVA and DVA as a smaller pupil size benefits NVA, while too small a pupil size can compromise DVA. Our study findings suggest that the optimum pupil size should be between 2.0 and 2.5 mm.
This abstract was presented at the 2022 ARVO Annual Meeting, held in Denver, CO, May 1-4, 2022, and virtually.