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Post-Hoc Analysis Shows Up to a 59% Reduction in Rate of Vision Loss in Iveric Bio's GA Treatment

03/01/2023

Iveric bio announced an exploratory time-to-event analysis from the avacincaptad pegol (ACP) GATHER clinical trial program evaluating reduction in vision loss with ACP 2 mg versus sham treatment. The GATHER1 and GATHER2 clinical trials were designed to evaluate the rate of geographic atrophy (GA) lesion growth in patients with GA secondary to age-related macular degeneration. The post-hoc analysis for vision loss from these pivotal studies signals up to a 59% reduction in rate of vision loss with ACP 2 mg compared to sham treatment at 12 months. Vision loss in this analysis was defined as a loss of ≥15 letters (EDTRS) in Best Corrected Visual Acuity (BCVA) from baseline measured at any two consecutive visits up to month 12. This analysis will be presented at the upcoming Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting from April 23-27, 2023.

Results were consistent in the GATHER1 and GATHER2 clinical trials independently, signaling a 44% reduction (Hazard Ratio 0.56 with 95% CI, 0.15-2.06) and a 59% percent reduction (Hazard Ratio 0.41 with 95% CI, 0.17-1.00) respectively in the rate of vision loss with ACP 2 mg compared to sham over the first 12 months of treatment. In a combined analysis of GATHER1 and GATHER2 shown in the accompanying graph, patients treated with ACP 2 mg experienced a 56% reduction (Hazard Ratio 0.44, with 95% CI, 0.21-0.92) in the rate of vision loss compared to sham over the first 12 months of treatment. This post-hoc analysis evaluates the potential vision loss signal through 12 months of treatment and is exploratory in nature.

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