Extending Treatment Intervals with Durable Therapies for nAMD and DME - Episode 4

Safety of New Therapies in nAMD and DME

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Retina specialists highlight the safety data of both faricimab and high-dose aflibercept for use in treating nAMD and DME.

Rishi P. Singh, MD: Apart from extended durability, what else do you think that we need to achieve from these therapies to really be meaningful in regard to your practice and your patients?

M. Ali Khan, MD, FACS, FASRS: I think safety is a big one. I think we’ve had experience with several recent drugs where safety concerns were brought up, perhaps after the clinical trials, and that I think is a big pause for most physicians, because the existing treatments we have are very safe in our hands. And I don’t think anyone wants the uncertainty or potential harmful effects of an unforeseen, perhaps inflammatory event that could cost a patient [their] vision. So I think safety after durability, of course, which is the primary end points in terms of these trials, there’s vision at a durable extended interval. But I think the safety concerns in the broader retina community are now paramount. That needs to be proven before I think people will truly adopt these drugs.

Rishi P. Singh, MD: Obviously, with any of these efficacy analyses, one of the other areas is potentially closure of the CNV [choroidal neovascularization] finally, or reduction of subretinal hyperreflective material, which we all think is the neovascular complex, which may benefit us to see that happen over time for sure from these drugs. And we talked about the safety profile of these drugs. Are there any new safety signals that were seen, any of these new drugs that have come out so far?

M. Ali Khan, MD, FACS, FASRS: Luckily, there wasn’t. So at least in the public trial data, there were similar rates of inflammation, which I think is the big one that most retina specialists are looking for nowadays between the comparator arms, which are aflibercept 2 mg every 8 weeks that had similar inflammatory events to the active arms of the trials, meaning the faricimab or the high-dose aflibercept. So hovering around 1% to 2% rates of inflammation and thromboembolic events, heart attack, stroke, no new safety signals in all of the trials.

Rishi P. Singh, MD: I would agree with you that we’re so cautious right now [about] safety because we have what we’ve seen with brolucizumab in the past. Obviously, we’ve seen some events recently with the drugs and geographic atrophy, which has been concerning to us. Our heightened awareness is definitely there for these drugs. And so we’re really making sure that there are no safety signals. Thankfully, both of these drugs, both faricimab and high-dose aflibercept, have not shown any concern as far and they’ve been used in clinical practice.

Transcript is AI-generated and edited for clarity and readability.