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David M. Brown, MD, discusses the full one-year data from the PULSAR and PHOTON trials and the implications of aflibercept 8 mg for patients with AMD and DME.
Extended dosing intervals with aflibercept 8 mg (EYLEA HD) were non-inferior to aflibercept 2 mg (EYLEA) in the treatment of wet age-related macular degeneration (AMD) and diabetic macular edema (DME), according to one-year results from the pivotal PULSAR and PHOTON trials.
Approval for aflibercept 8 mg was awarded by the US Food and Drug Administration (FDA) in August 2023, based on 48-week PULSAR and PHOTON findings. These data, published in the LANCET, demonstrated the extended 12- or 16-week dosing intervals of aflibercept 8 mg had non-inferior vision improvement to the standard-of-care aflibercept.
In an interview with HCPLive, David M. Brown, MD, Retina Consultants of Texas, and the first author of the PHOTON publication, described the importance of the extended intervals with aflibercept 8 mg for patients who are already dealing with an influx of health issues.
“It’s convenient for the macular degeneration population, but the diabetic population is younger, has to take time off to get their injections, and has a lot of comorbidities where they have a lot of other doctor’s appointments anyway,” Brown told HCPLive. “Anything we can do to decrease the difficulty in getting these sight-saving medications to patients, the better our outcomes end up being on a population basis.”
Brown spoke to the rapid adoption of aflibercept 8 mg, particularly given its status as a “high-dose” version of a very well-understood drug, with more than 70 million doses of aflibercept 2 mg provided worldwide. He noted that most of his patients treated with aflibercept 2 mg were moved to aflibercept 8 mg without resistance and most doing well with an extended interval.
“We treat and extend here in the US for most of our care, both in AMD and DME, despite it not being on the exact label. The drug is definitely lasting longer in almost every patient, which is fantastic,” Brown told HCPLive.
However, Brown indicated the importance of setting realistic expectations for a patient’s treatment needs. He noted the average patient needs an average number of shots, while a difficult-to-treat patient may require more shots, who are typically patients seen frequently in retina practices.
“Your waiting room is not indicative of a bell curve, where you have easy ones and hard ones. It’s got a lot more ones that are frequent fliers,” Brown told HCPLive. “I think the most likely thing is that some patients, just by the nature of their eyeball, clear the drug faster.”
Brown also spoke to the impressiveness of the 96-week PULSAR and PHOTON data, presented at the 2023 American Academy of Ophthalmology (AAO) annual meeting, noting the data on aflibercept 8 mg exceeded his expectations.
“In the clinic, we’re going to need more injections than you saw in the publications. However, in the real world, it’s playing out that people are getting by with less frequent injections and dry retinas,” Brown told HCPLive. “In other words, patients that were almost never dry on another agent are becoming dry with aflibercept 8 mg.”
For further insight into the role of aflibercept 8 mg in retina care, watch the full interview with Brown in the video above.
Disclosures: David M. Brown, MD reports receiving consultant fees from Regeneron, Bayer, and Genentech/Roche.
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