IVERIC bio, Inc. has announced positive Phase 3 results from its GATHER1 clinical trial with Zimura® (avacincaptad pegol). As published in the September issue of Ophthalmology®, Zimura® met its pre-specified primary efficacy endpoint at 12 months and reached statistical significance in GATHER1, an international, multicenter, randomized, double masked, sham controlled clinical trial.
Zimura® inhibits complement factor C5, which is believed to be involved in the development of AMD. The reduction in the mean rate of geographic atrophy (GA) growth over 12 months was better than 27% group as compared to sham control groups. The data was statistically significant, and the drug was generally well tolerated.
“GATHER1 is currently the only Phase 3 clinical trial I am aware of showing early suppression of GA growth which continued throughout the trial with continuous treatment out to 18 months,” said Glenn Jaffe, M.D., (lead author) and Robert Machemer (Professor of Ophthalmology, Duke University).
GATHER2 is currently underway to further evaluate the efficacy and safety of Zimura in patients with GA.
For summaries of all leading studies for dry AMD, see A Guide to Research in Dry AMD.
SOURCE: Press Release