Deepak Sambhara, MD: Impact of Aflibercept 8 mg Durability for AMD, DME

One-year data from the phase 3 PULSAR and PHOTON trials demonstrated the noninferiority of aflibercept 8 mg (EYLEA HD) to aflibercept 2 mg (EYLEA) in the treatment of wet age-related macular degeneration (AMD) and diabetic macular edema (DME).

The US Food and Drug Administration (FDA) approved aflibercept 8 mg in August 2023, based on 48-week findings from the pivotal trials. In a recent interview with HCPLive, Deepak Sambhara, MD, medical director of research and partner at Eye Clinic of Wisconsin, described how clinical practice has changed since its approval for patients with AMD and DME.

“Aflibercept 8 mg is a vital tool in our toolkit, it represents another durable agent that we can turn to as retina specialists and ophthalmologists in treating a retinal vascular disease,” Sambhara told HCPLive. “When I saw the [PULSAR and PHOTON] trial data, my question was, ‘How is this going to translate to my practice?’ and what I found from being an early adopter is I’m able to get a subset of my population out further than ever before on aflibercept 2 mg.”

When a new anti-vascular endothelial growth factor (VEGF) product hits the market, retina specialists often turn to patients with recalcitrant disease to evaluate the treatment response. Sambhara noted aflibercept 8 mg was a particularly impressive agent for his recalcitrant patient population, but more real-world data is needed to conclude its role.

“I think the jury is still out, we’re going to need quantifiable real-world data to make sweeping conclusions,” he told HCPLive. “But I have been very impressed with my use of aflibercept 8 mg in my patient population to date.”

Sambhara spoke on his familiarity with standard-of-care aflibercept 2 mg and confidence in the higher-dose agent showing a similar safety profile, in combination with the efficacy data reported in the PULSAR and PHOTON clinical trials. He noted the encouraging 96-week data from last year’s American Academy of Ophthalmology (AAO) meeting added to the belief that his patients may be able to be extended even further than before.

“The way it gives me comfort as a retina specialist practicing day to day is the fact that we live in a world where our clinics are overloaded, Sambhara told HCPLive. “Durability is the name of the game; it is key to keep our clinic flows going to keep patients getting medicines in a timely fashion.”

In Wisconsin, where Sambhara practices, weather can be a deciding factor for patients to visit the clinic for treatment. Extended durability may be able to provide additional time for a patient to receive an injection, providing comfort for retina specialists who want to preserve a patient’s vision.

“If a patient has to reschedule, due to inclement weather or something happens, I can hang my hat on the efficacy data that exists and potentially feel a little bit better,” Sambhara told HCPLive. “Add to that, the efficacy and durability of aflibercept 8 mg is better than what we’ve seen with 2 mg and that’s a game changer for patients who have larger treatment burdens or long distances to travel.”

For more insight into the role of aflibercept 8 mg, watch the full interview with Sambhara in the above video.

Sambhara reports relevant advisory and speaking bureau disclosures with Apellis Pharmaceuticals, Genentech, Regeneron Pharmaceuticals, and Iveric Bio.

_References

1. _{Iapoce C. Aflibercept 8 mg exhibits non-inferior vision gains in Pulsar, photon trials. HCP Live. March 8, 2024. Accessed March 25, 2024. https://www.hcplive.com/view/aflibercept-8-mg-non-inferior-vision-gains-pulsar-photon-trials.}
2. _{Eylea® HD (aflibercept) injection 8 mg pivotal data in wet age-related macular degeneration (wamd) and diabetic macular edema (DME) published in the Lancet. Regeneron Pharmaceuticals Inc. March 8, 2024. Accessed March 25, 2024. https://investor.regeneron.com/news-releases/news-release-details/eylear-hd-aflibercept-injection-8-mg-pivotal-data-wet-age.}
3. _{Campbell P. Aflibercept 8 mg (eylea HD) approved by FDA for wet AMD, DME, and Diabetic retinopathy. HCP Live. August 23, 2023. Accessed March 25, 2024. https://www.hcplive.com/view/aflibercept-8mg-eylea-hd-approved-by-fda-for-wamd-dme-and-diabetic-retinopathy.}