Iveric Bio announces positive topline data from Phase III trial into geographic atrophy
IVERIC bio has announced positive topline results from GATHER2, the company’s second Phase III trial of Zimura (avacintcaptad pegol), a novel investigational complement C5 inhibitor for the treatment of geographic atrophy (GA).
GATHER2 met its prespecified primary endpoint of mean rate of growth (slope) in GA area at 12 months, with statistical significance and a favourable safety profile.
Zimura is an investigational drug ‒ anovel complement C5 protein inhibitor, not currently approved in any country. Overactivity of the complement system and the C5 protein are suspected to play a critical role in the development and growth of scarring and vision loss associated with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Through blocking the activity of C5, Zimura may decrease activity of the complement system, which causes the degeneration of retinal cells, and potentially slow the progression of GA.
Age-related macular degeneration
(AMD) is the major cause of moderate and severe loss of central vision in ageing adults, affecting both eyes in the majority of patients. Geographic atrophy, the advanced stage of AMD, leads to further irreversible loss of vision in these patients.
“We are thrilled to see for the first time an investigational therapy with a statistically significant reduction in the rate of GA progression at the 12-month primary endpoint across two Phase III clinical trials,” stated Glenn P Sblendorio, CEO of Iveric
Bio. “The results from GATHER1 and GATHER2 and our Special Protocol Assessment with the FDA provide the basis for an NDA, which we are planning to submit by the end of first quarter of 2023. We look forward to engaging with the FDA throughout the review process. I want to thank the many patients, physicians, and their staffs for their participation in the Zimura clinical program along with the employees of Iveric Bio for their dedication to achieve this important milestone.”