Abstract
Purpose :
Evaluate the efficacy of AGN-190584 in extending depth of focus over the course of 30 days.
Methods :
Analysis was pooled from identical phase 3 studies GEMINI 1 and GEMINI 2. Participants (N=750) were randomized to receive AGN-190584 or vehicle once daily, bilaterally for 30 days. Depth of focus was measured in diopters (D) using a phoropter in the dominant and non-dominant eyes at hours 0 and 1 post instillation on Days 1, 3, 7, 14, and 30.
Results :
Mean depth of focus change from baseline in the AGN-190584 group for the dominant eye was 0.448, 0.484, 0.569, 0.663, and 0.726 D on Days 1, 3, 7, 14, and 30 at Hour 1 compared to a mean of 0.118, 0.114, 0.136, 0.178, and 0.191 D in the vehicle control group (Figure 1A). Mean depth of focus change from baseline in the AGN-190584 group for the non-dominant eye was 0.422, 0.462, 0.568, 0.664, and 0.699 D on Days 1, 3, 7, 14, and 30 at Hour 1 compared to a mean of 0.046, 0.119, 0.105, 0.156, and 0.157 D in the vehicle control group (Figure 1B). All data points for both the dominant and non-dominant eye were statistically significant at Hour 1 in favor of the active treatment group (achieving greater depth of focus). Mean letters of improvement in mesopic distance-corrected near visual acuity (DCNVA) at Hour 1 were 8, 8.9, 9.7, 10.6, and 10.8 in the AGN-190584 group on Days 1, 3, 7, 14, and 30 compared to 3, 4.1, 4.5, 5.1, and 5.3 in the Vehicle group (Figure 2). All data points were significantly higher in the AGN-190584 group compared to the Vehicle group with p<.0001.
Conclusions :
Extended depth of focus was greater in the active treatment group compared to the vehicle control group as early as Day 1 Hour 1. Over the course of the 30 day study, a gradual increase in depth of focus was observed possibly suggesting a neuroadaptation response perhaps similar to what has been observed with Extended Depth of Focus (EDOF) Intraocular Lenses. With increased depth of focus and corresponding improvements in visual acuity from the pinhole effect there may be a learning period in which the visual cortex learns to process and utilize the EDOF. Letters of improvement in mesopic DCNVA at Hour 1 followed a similar upward trend over the 30 day studies.
This abstract was presented at the 2022 ARVO Annual Meeting, held in Denver, CO, May 1-4, 2022, and virtually.