Iveric Bio reveals vision loss reduction data in investigational geographic atrophy therapy

US biopharmaceutical company Iveric Bio has released new data for its avacincaptad pegol (ACP) therapy for geographic atrophy (GA), which showed up to a 59% risk reduction in rate of vision loss compared to sham treatment at 12 months.

In March, the company announced an exploratory time-to-event analysis from its GATHER clinical trial program evaluating reduction in vision loss with ACP 2 mg versus sham treatment.

GATHER1 and GATHER2 – both of which are randomised, double-masked, sham-controlled, multicentre Phase 3 clinical trials – were designed to evaluate the rate of lesion growth in patients with GA secondary to age-related macular degeneration.

ACP is an investigational drug currently under evaluation for safety and efficacy by the US FDA, which recently approved the country’s first GA therapy, SYFOVRE (pegcetacoplan injection), in February 2023.

ACP works as a complement C5 protein inhibitor, and is based on the theory that overactivity of the complement system and the C5 protein plays a critical role in the development and growth of scarring and vision loss associated with GA secondary to AMD. By targeting C5, ACP has the potential to decrease activity of the complement system that causes the degeneration of retinal cells and potentially slow the progression of GA.

Iveric Bio’s post-hoc analysis for vision loss from the pivotal GATHER 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.

“GA is a devastating disease, which can lead to vision loss and irreversible blindness taking away the patients’ ability to drive, read and see their loved ones,” said Dr Arshad Khanani, managing partner and director of clinical research at Sierra Eye Associates in Nevada.

“On average, it takes 2.5 years for GA lesions to start impacting central vision. Early treatment effect has the potential to change the trajectory of disease for patients. A reduction in rate of vision loss with ACP 2 mg of up to 59% compared to sham treatment at 12 months supports the clinical relevance of the GATHER1 and GATHER2 primary endpoint, which met statistical significance.”

According to Iveric, the results were consistent in the GATHER1 and GATHER2 clinical trials independently, signalling 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 below 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.