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Will the complement C5 inhibitor drug receive FDA approval in 2023? Lally discusses this and more on the latest DocTalk.
Over the last decade, the complement inhibitor drug class has emerged as the likely first response to geographic atrophy (GA), a form of age-related macular degeneration (AMD) progression that currently has no US Food and Drug Administration (FDA)-approved therapies.
In the coming year, a couple of agents from this drug class are anticipated to receive FDA consideration, including Iveric Bio’s avacincaptad pegol, a C5 inhibitor intravitreal injection that now has 2 supporting datasets from the pivotal phase 3 GATHER clinical trial program.
What makes avacincaptad pegol a viable option for patients with GA, and what should ophthalmologists derive from GATHER 1 and 2? What are the prospects of long-term disease management with the C5 inhibitor? What else do investigators still need to learn?
In the latest episode of DocTalk, David Lally, MD, an investigator and ophthalmologist with New England Retina Consultants, joins to discuss various matters surrounding GA, avacincaptad pegol, the GATHER trials, and more.
With supporting data having accumulated enough evidence for an FDA submission by Iveric Bio, Lally also discussed the prospect of regulated therapies for patients with GA, as well as details for an extension assessment in GATHER 2 patients.