Perspective from trial investigators and ophthalmologists on the novel drug, just prior to its potential FDA approval.
The US Food and Drug Administration (FDA) is anticipated to rule on the New Drug Application (NDA) for Roche’s faricimab as a treatment for adults with neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME) at some point today.
The investigative bispecific antibody angiopoietin-2 (Ang-2) and vascular endothelial growth factor A (VEGF-A) inhibitor is anticipated to receive approval on the basis of 4 pivotal phase 3 trials showing its benefit in either disease—which happen to be the 2 leading causes of irreversible blindness in the US. As such, it would be a novel therapy in a space in need of all the agents that could provide help for patients losing vision.
Leading up to the FDA decision, HCPLive spoke with trial investigators and ophthalmologists to understand what impact could be expected from a marketed faricimab.
Charles C. Wykoff, MD, an investigator on the pivotal YOSEMITE and RHINE clinical trials assessing faricimab in patients with DME, explained that he’s always in favor of “more tools in the toolbox.”
With the prevalence and burden of nAMD and DME being what it is in the US, the utility of any available therapies, including anti-VEGFs, is “incredibly valuable.”
“We have excellent medications already,” Wykoff said. "My hope is that faricimab fits in to our existing toolbox to help patients that are not achieving dryness with current agents have a better shot of getting a dry retina and stabilizing their anatomy, and for patients who are unable to achieve extended durability between injections hopefully be able to decrease their treatment burden over time.”
Over time, investigators aim to assess YOSEMITE and RHINE patients for two-plus years, understanding the observed link between intraocular inflammation risk and faricimab—however, Wykoff doesn’t believe it to be a “clinically meaningful association.”
Carl Regillo, MD, Director of Retina Service, Wills Eye Hospital and investigator of the TENAYA and LUCERNE trials for faricimab in patients with nAMD, noted that the observed efficacy of the novel therapy is as strong as standard-care aflibercept (EYLEA) in visual outcomes—both in initial loading phases as well as in maintenance. The key difference is the reduced treatment load required with faricimab.
“The bottom line is these studies show definitively that faricimab works as well as aflibercept in exudative control of nAMD and achieving the vision gains that are well maintained over time after the initial loading phase, but with less frequent treatment,“ Regillo told HCPLive at the American Academy of Ophthalmology (AAO) 2021 Annual Meeting. “Having something that's more durable or longer acting is simply more forgiving, if you will.”
Regillo added that patients would be required to visit the clinicians office less frequently with such a prescription. Joshua Mali, MD, of The Eye Associates, echoed a similar sentiment to HCPLive on a podcast last year. The Florida-based clinician expressed excitement for extended outcomes observed under the unique faricimab treatment regimen.
“It could be a potential game-changer in regards to wet AMD and how we treat patients,” Mali said. “The potential of 16-week dosing is very exciting.”
On a recent HCPLive Peer Exchange video panel, Ehsan Rahimy, MD, of Sutter Health, highlighted the excitement of faricimab as a novel targeting therapeutic. As he noted, the ideal future of ophthalmic care is having various therapies available and personalizing treatment for the right patient.
“It’s sobering and disappointing so far in retina, anytime a new therapeutic target has come close to getting to the market, we’ve been met with disappointing clinical trials,” Rahimy explained. “We hear our colleagues, and sometimes I consider, ‘Maybe this is as good as it gets. Maybe all we have really is VEGF and steroids, and maybe that’s what we need to consider.’ You can see that reflected on the clinical trial.”
The idea that faricimab can improve on anti-VEGF therapies by providing longer-lasting benefit for patients with nAMD and DME is not far-fetched; that it’s the first of many other agents that could do so is the greater hope.
“We discuss personalized medicine and that’s what we’re aiming for our patients; to figure out what combinations of therapeutic targets we can match with therapy to get the best possible outcomes for the longest duration of time,” Rahimy said.