Dr. Modi discusses the pending approval of faricimab for nAMD, DME treatment and highlights important observations from phase 3 data.
In an interview with HCPLive, Yasha S. Modi, MD, NYU Langone Health, discusses the pending FDA approval of faricimab for the treatment of both neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME). Faricimab is a novel angiopoietin-2 and vascular endothelial growth factor-A bispecific antibody.
Two sets of landmark phase 3 studies were the basis for the pending approval, including the TENAYA and LUCERNE for nAMD and YOSEMITE and RHINE for DME. Each found a reduced treatment burden and extended durability with faricimab.
"This is a unique molecule because unlike other molecules, which only block anti VEGF, this blocks, not only VEGF, but it also blocks angiopoietin-2," Modi said. "This unique molecule gives us the opportunity to have dual effect not only on minimizing VEGF expression, but also to promote vascular stabilization."
Modi went on to discuss the considerable treatment burden of frequent injections and how new new drugs have attempted to increase durability between injections, without sacrificing efficacy.
He pointed out that the studies were designed to compared aflibercept (EYLEA) every 8 weeks versus fairicmab with the option to go to 12 or 16 weeks.
"In nAMD, about 80% of patients cut out to 12 weeks or longer, of which about 45% were able to get up to 16 weeks, which is pretty incredible," Modi said. "Similarly, in the RHINE and Yosemite studies, about 50% of individuals were able to get out to 12 weeks or more."
While he noted that aflibercept was not given the chance to extend to those time points in the study, as a noninferiority trial, other studies may show that faricimab does have an increased durability when compared to aflibercept.
Additionally, Modi spoke to the expected uptake of faricimab. He noted that another agent, Brolucizimab, experienced higher reports of inflammation than what was expected after the phase 3 studies, so investigators are prepared to look for the same complications.
"Assuming that we can recapitulate similar safety profiles to what is in the phase 3 trials, I think there's going to be a very rapid uptake in the number of doctors who are utilizing this medication to allow patients sort of similar efficacy to that of EYLEA but the longer duration between treatment," Modi explained.