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Newly approved high dose aflibercept tipped to reach ‘blockbuster’ status

high dose aflibercept


Bayer’s high dose aflibercept 8 mg – now approved in the European Union and US – has been labelled one of 13 potential blockbuster drugs for 2024 in the annual ‘Drugs to Watch’ report by global analytics firm Clarivate.

The anti-VEGF therapy for neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME) was the only ophthalmic therapy to make the 2024 list comprising late-stage treatments forecast to deliver annual sales of more than US$1 billion (AU$1.5 b) within five years.

Other treatments to make the list were Datopotamab deruxtecan (Dato-DXd) for breast cancer, Efanesoctocog alfa (ALTUVIIIO) for hemophilia A and Mirikizumab (Omvoh) for Crohn’s disease, among others.

Aflibercept 8 mg represents a higher dose to the standard of care aflibercept 2 mg (marketed as Eylea 2 mg), which is currently offered to patients in Australia. Aflibercept 8 mg was first approved in the US in September 2023 where it will be known as Eylea HD. Then, on 8 January 2024, Bayer confirmed clearance for the European market where it will be known as Eylea 8 mg.

The approvals have been based on positive results from the PULSAR clinical trial in nAMD and the PHOTON trial in DME. Both studies met their primary endpoint of non-inferior best corrected visual acuity changes with aflibercept 8 mg with 12- or 16-week dosing regimens compared to aflibercept 2 mg (Eylea 40 mg/ml) with a fixed eight-week treatment interval at week 48. In these studies, the safety profile of aflibercept 8 mg was consistent with the well-established safety profile of Eylea (aflibercept 2 mg).

Subsequently, Bayer said aflibercept 8 mg was the only EU drug that is approved for nAMD and DME for extended treatment intervals of up to five months.

Analysis in the Drugs to Watch said the real benefit is expected from the need for fewer injections to reach equivalent visual acuity gains and anatomical features as Eylea without compromising safety, therefore reducing the treatment burden for patients and healthcare providers.

“The frequency and time requirement of clinic visits take a toll on patient and caregiver quality-of-life and can be particularly burdensome for the working-age population and patients who cannot drive. High-dose aflibercept affords extended dosing intervals while offering favourable safety and efficacy profiles, greatly reducing the administrative and follow-up burden of treatment on patients, caregivers and healthcare providers,” the report noted.

“Compelling trial results through two years reinforce the ability of Eylea HD to prolong treatment intervals of at least 12 weeks to a meaningful proportion of patient.”

The report also identified hurdles that may need to be overcome to reach blockbuster status, including the launch of biosimilar versions of aflibercept that are expected to erode the patient share of the Eylea franchise, including Eylea HD.

“Clarivate experts expect that, by 2032, approximately 45% of US patients with drug-treated wet AMD receiving aflibercept will receive Eylea HD while 34% will receive an aflibercept biosimilar,” the report said.

“Moreover, they expect that 43% of US patients with wet AMD will receive a competing, newly launched therapy (including biosimilars) by 2032. Novel therapies in development include treatments promising even longer dosing intervals than Eylea HD and gene therapies that could require a single IVT injection, which would greatly reduce the burden of treatment.

“Furthermore, Eylea HD will have to compete with Vabysmo, its biggest rival currently on the market. With a novel mechanism of action, Vabysmo became the first injectable drug allowing administration to up to 16 weeks while providing a safety and efficacy profile consistent with that of Eylea. Vabysmo experienced rapid uptake shortly after its launch in early 2022, which will have a negative impact on the blockbuster status of Eylea HD.”

More reading 

Bayer’s aflibercept 8 mg recommended for approval in EU

FDA clears higher dose Eylea; approvals sought in other markets

Vabysmo listed on PBS for first time


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