Evolving Treatment Landscape in nAMD, DME Reduces Patient Burden, Improves Outcomes: Casey Koch, PharmD

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Novel treatment approaches for neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME) are being explored to reduce patient burden and improve adherence and visual outcomes. Recently, new therapies have entered the market, including a high-dose aflibercept (Eylea), the bispecific faricimab (Vabysmo), and a port delivery system that is refillable every 6 months placing less of a burden on patients, explained Casey Koch, PharmD, MBA, BCACP, pharmacy coordinator, Select Health. There are also new mechanisms of action and potential gene therapies on the horizon.

“We also now have a few biosimilars on the market,” Koch said. “[I’m] hopeful that we can see a lot of competition in that space [with the] potential to get some costs down from a population health standpoint.”

The first biosimilars approved in the eye space were the ranibizumab biosimilars Byooviz (Samsung Bioepis and Biogen) and Cimerli (Coherus Biosciences), approved September 2021 and August 2022, respectively.^1,2 Cimerli was approved with the interchangeability designation, while Byooviz gained it later.³

In addition, there are now 5 aflibercept biosimilars approved in the US, 3 of which have been granted the interchangeability designation: Yesafili (Biocon Biologics) and Opuviz (Samsung Bioepis), which were both approved on May 20, 2024; and Enzeevu (Sandoz), approved on August 12, 2024.^4,5

Treatments for these conditions are generally accessible; however, patients usually have a coinsurance for these therapies, which can be high, and prior authorization is often required and creates a barrier.

“There's a big push to get same-day prior authorization approved for these patients, so that they can inject in the office,” Koch said. “If the patient needs to go home and come back, there's a chance that we're going to lose that patient and they're not going to come back for the injection.”

References

1. Hagen T. FDA approves first ophthalmology biosimilar: a ranibizumab. The Center for Biosimilars^®. September 20, 2021. Accessed April 29, 2025. https://www.centerforbiosimilars.com/view/fda-approves-first-ophthalmologoy-biosimilar-a-ranibizumab

2. FDA approves Coherus’ Cimerli as interchangeable biosimilar to ranibizumab. The Center for Biosimilars. August 3, 2022. Accessed April 29, 2025. https://www.centerforbiosimilars.com/view/fda-approves-coherus-cimerli-as-interchangeable-biosimilar-to-ranibizumab

3. Jeremias S. Eye on pharma: new GI data and Byooviz interchangeability propel biosimilars into the future. The Center for Biosimilars. October 25, 2024. Accessed April 29, 2025. https://www.centerforbiosimilars.com/view/eye-on-pharma-new-gi-data-and-byooviz-interchangeability-propel-biosimilars-into-the-future

4. Jeremias S. FDA approves first Eylea biosimilars. The Center for Biosimilars. May 20, 2024. Accessed April 29, 2025. https://www.centerforbiosimilars.com/view/fda-approves-first-eylea-biosimilars

5. Jeremias S. FDA approves biosimilar Enzeevu for eye conditions. The Center for Biosimilars. August 12, 2024. Accessed April 29, 2025. https://www.centerforbiosimilars.com/view/fda-approves-biosimilar-enzeevu-for-eye-conditions