A post hoc analysis of data from the phase 3 GATHER1 and GATHER2 clinical trials showed that avacincaptad pegol (ACP), an investigational complement C5 inhibitor,  achieved positive results in vision loss reduction in patients with geographic atrophy (GA), according to a press release from Iveric Bio. (A post-hoc analysis looks at data from a clinical trial after it has been completed.) There was up to a 59% reduction in rate of vision loss with ACP 2 mg compared with sham after 12 months of treatment. Further data will be presented at the Association for Research in Vision and Ophthalmology meeting in April. 

“On average, it takes 2.5 years for GA lesions to start impacting central vision,” Arshad M. Khanani, MD, MA, FASRS, said in the release. “Early treatment effect has the potential to change the trajectory of disease for patients.” 

In February, the FDA granted priority review for a new drug application for ACP. Priority reviews evaluate applications for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions. The submission was supported by positive 12-month efficacy and safety results from the GATHER1 and GATHER2 clinical trials, in which ACP demonstrated observed efficacy rates of up to 35% for the treatment of geographic atrophy. 

Healio, March 1, 2023 and February 17, 2023; see source article 1 and source article 2