For individuals with wet age-related macular degeneration (AMD), diabetic macular edema (DME) or diabetic retinopathy (DR) whose treatment choices include invasive, burdensome administration that limits treatment uptake, high-dose aflibercept offers less-frequent administration while achieving similar efficacy and safety as the current standard of care (aflibercept 2 mg/EYLEA dosed every 8 weeks or LUCENTIS®
from Genentech dosed every 4 weeks). More convenient for patients and clinicians alike, the 12- and 16-week dosing helps meet a significant unmet need for these patient populations.
February 2023
March 2023
August 2023
For patients with wet AMD, DME or DR
Actual and expected launch:
Patents estimated to expire beginning in 2039
How will high-dose aflibercept impact the market for wet AMD, DME and DR?
What gaps in treatment does high-dose aflibercept fill?
The biggest unmet need for patients with DME or wet AMD has been clinically superior therapies with more convenient delivery profiles than available treatments. 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 favorable safety and efficacy profiles, greatly reducing the administrative and follow-up burden of treatment on patients, caregivers and healthcare providers.
What hurdles might it need to overcome to reach blockbuster status?
The launch of biosimilar versions of aflibercept are expected to erode the patient share of the EYLEA franchise, including EYLEA HD. Clarivate experts expect that, by 2032, approximately 45% of U.S. patients with drug-treated wet AMD receiving aflibercept will receive EYLEA HD while 34% will receive an aflibercept biosimilar. Moreover, they expect that 43% of U.S. 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.
– Source: Cortellis Competitive Intelligence, Drug Timeline & Success Rates Prediction current as of November 3, 2023
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