Standard of care for neovascular AMD

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Dual Mechanism of Action

February 16, 2023

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Editor's note: This is an automatically generated transcript. Please notify editor@healio.com if there are concerns regarding accuracy of the transcription.

As it stands, the mainstay standard of care for treatment of neovascular AMD is anti-VEGF therapy, including known and long-standing use of bevacizumab, ranibizumab, aflibercept, and brolucizumab in that order of approval and commercial availability in addition to more recently approved biosimilar agents to these molecules. That said, though, there is still the need to mitigate treatment burden for patients and providers, including a need for more durable treatments. So one year ago, we saw FDA approval for faricimab, which has a dual mechanism of action, suppressing both VEGFA and Ang2 And in the clinical trials, we saw non-inferiority compared to aflibercept on-label treatment in the Phase 3 programs for neovascular AMD. That is the Tenaya and Lucerne trials. And we also saw in those trials a strong signal for increased durability. And almost 80% of patients in the trials were able to extend their treatment intervals based on trial criteria to Q-12 and Q-16 week intervals. And so now that the product is commercially available, we're beginning to learn through the IRIS Registry how this treatment option is being incorporated into clinical practice. And we will await further data in the real world on durability. We need time to assess that. But with further use, we may also be able to understand the specific role of Ang2 and the anti-Ang2 component when combined with anti-VEGF as it is in this formulation. Other treatments potentially on the horizon are high-dose aflibercept, which showed promising results when compared to current aflibercept in Phase 3 trials. And also studies that are in earlier stages, including broader suppression of VEGF, the combined use of current anti-VEGF treatments with tyrosine kinase inhibitors, as well as cutting edge potential for intraoperative, or even in-office gene therapy for the treatment of neovascular AMD. So I think exciting times to come.

Healio spoke with Ferhina S. Ali, MD, MPH, about treatment options for patients with age-related macular degeneration.

“As it stands, the mainstay standard of care for treatment of neovascular AMD is anti-VEGF therapy,” Ali said.

These include therapies such as bevacizumab, ranibizumab, aflibercept and brolucizumab, as well as recently approved biosimilars.

However, it is still critical to “mitigate treatment burden for both patients and providers,” and there is a need for “more durable treatments,” according to Ali, a vitreoretinal physician and surgeon with the Westchester Medical Center Health Network and an assistant professor at New York Medical College.

Faricimab, a bispecific monoclonal antibody that inhibits both VEGF-A and Ang-2, may offer this much needed durability through its dual mechanism of action.

“Now that the product is commercially available, we’re beginning to learn through the IRIS Registry how this treatment option is being incorporated into clinical practice, and we will await further data in the real world on durability,” Ali said. “We need time to assess that.”

She also discussed “other treatments potentially on the horizon” for AMD, including high-dose aflibercept, combination therapy options and gene therapy.