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An FDA decision could come as soon as this year. One expert stresses the need for improved screening, biomarker research, and patient communication beforehand.
Potentially later this year, either of a pair of companies may submit applications for their promising agent to become the first US Food and Drug Administration (FDA) approved drug for patients with geographic atrophy (GA).
Avacincaptad pegol from Iveric Bio, pegcetacoplan from Apellis Pharmaceutical, and a series of other promising agents are accumulating patient-implicative findings showing would-be benefit for patients with GA—a progression of worsened disease from age-related macular degeneration (AMD).
While many would believe a landmark indication for treating GA would be considered a punctation on decades of research, one expert argued it’s simply “the tip of the iceberg.”
In the second segment of an interview with HCPLive during the Association for Research in Vision and Ophthalmology (ARVO) 2022 Meeting this week, Theodore Leng, MD, MS, associate professor of ophthalmology at Stanford University, discussed his vested interest in potential GA agents including pegcetacoplan.
“I think we’re all very hopeful in our subspecialty of retina that one of these agents will make it through the FDA process, hopefully later this year,” Leng said. “The combined dataset from PHILLY (phase 2) and DERBY & OAKS (phase 3) will hopefully allow this first product to make it to market and allow us to start treating patients with this severe form of macular degeneration.”
Leng also spoke to other potential GA drug classes, such as complement factor and growth factor inhibitors, as well as cell-based therapies that could possibly provide regenerative visual benefit. Along the way, it’ll be key for clinicians and investigators alike to seek methods of identifying the ideal candidates for care—and assuring the method of care is fully spoken to.
“It’s going to be a challenge, to be honest, to identify the right eye in the right patient to start a therapy that is not going to have a tangible benefit the patient is going to perceive upon initiation or even during the course of therapy,” Leng said. “Patient selection, eye selection, and the conversation with patients is something we’re going to work through as a specialty when one of these agents comes out.”
Leng anticipates that, once GA therapies reach the US market, industry research may shift toward seeking ideal progressive AMD cases, as well as GA-risk biomarkers or symptoms, to optimize available treatments.
“A lot of the work I’ve been doing, looking at imaging and analysis, is specifically looking for these biomarkers of progression,” he said. “If we could take an OCT, an autofluorescence image or infrared image at a certain time point, and based on identifiable biomarkers for disease progression show reduction in those biomarkers with the administration of an agent…that’s kind of the holy grail at this point.”