Iveric Bio's GA Treatment Shows Up to 59% Reduction in Vision Loss

Iveric Bio has made public an exploratory analysis of time-to-event from the avacincaptad pegol (ACP) GATHER clinical trial program. This analysis evaluates the reduction in vision loss using ACP 2 mg compared to sham treatment. The GATHER1 and GATHER2 clinical trials were specifically designed to assess the rate of growth of geographic atrophy (GA) lesions in patients with GA resulting from age-related macular degeneration.

An analysis performed after the fact regarding vision loss from the pivotal studies suggests a possible up to 59% decrease in the rate of vision loss when using ACP 2 mg versus sham treatment after 12 months. For the purposes of this analysis, vision loss was defined as a decline of ≥15 letters (EDTRS) in Best Corrected Visual Acuity (BCVA) from the baseline as measured at any two consecutive visits up to month 12. The results of this analysis will be presented at the forthcoming Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting, taking place from April 23-27, 2023.

The outcomes of the clinical trials GATHER1 and GATHER2 were consistently aligned, indicating that there was a reduction of 44% (Hazard Ratio 0.56 with 95% CI, 0.15-2.06) and 59% (Hazard Ratio 0.41 with 95% CI, 0.17-1.00) in the rate of vision loss with ACP 2 mg compared to the sham during the initial 12 months of treatment.

The graph displayed in conjunction with the combined analysis of GATHER1 and GATHER2 illustrates that patients who received ACP 2 mg during the initial 12 months of treatment experienced a decrease of 56% (Hazard Ratio 0.44 with 95% CI, 0.21-0.92) in the rate of vision loss compared to those who were given sham treatment. This analysis was performed after the fact and aimed to investigate any possible signals of vision loss during the 12-month treatment period. It should be noted that this analysis was exploratory in nature.