Iveric Bio has released data that suggests its investigational treatment could reduce the rate of vision loss by 59% for patients with geographic atrophy (GA) resulting from age-related macular degeneration (AMD).
Iveric Bio has made public an exploratory analysis of time-to-event from the avacincaptad pegol (ACP) GATHER clinical trial program.
The analysis evaluates the reduction in vision loss using ACP 2mg – a novel complement C5 inhibitor administered by intravitreal injection – compared to sham treatment.
The GATHER1 and GATHER2 clinical trials were specifically designed to assess the rate of growth of GA lesions in patients with GA resulting from AMD.
Consistent Results
“The post-hoc analysis for vision loss from these pivotal studies signals up to a 59% reduction in rate of vision loss with ACP 2mg compared to sham treatment at 12 months,” Iveric Bio stated.
“Vision loss in this analysis was defined as a loss of ≥15 letters in Best Corrected Visual Acuity from baseline measured at any two consecutive visits up to month 12.”
The company said results were consistent in GATHER1 and GATHER2 clinical trials independently, “signalling a 44% reduction…and a 59% reduction… respectively in the rate of vision loss with ACP 2mg compared to sham over the first 12 months of treatment”.
“In a combined analysis of GATHER1 and GATHER2… patients treated with ACP 2mg experienced a 56% reduction 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,” the company said. As a result of the GATHER1 and GATHER2 trials, the FDA accepted a new drug application in February and is currently evaluating the treatment. ACP is the only investigational therapy to have received the ‘Breakthrough Therapy’ designation for the treatment of GA that is secondary to AMD.
The results of this analysis were presented at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting.
