New Treatment Approach for Aflibercept Approved in Europe

The updated treatment approach will allow clinicians, based on individual patients’ outcomes, to lengthen the intervals between injections for patients with neovascular age-related macular degeneration (AMD) who are already in the first year of treatment. That could mean fewer injections and fewer trips to the clinic for patients with AMD.
The Center for Biosimilars Staff
August 05, 2018
Bayer has announced that the European Commission has approved a new treatment regimen for aflibercept (Eylea). The updated treatment approach will allow clinicians, based on individual patients’ outcomes, to lengthen the intervals between injections for patients with neovascular age-related macular degeneration (AMD) who are already in the first year of treatment. That could mean fewer injections and fewer trips to the clinic for patients with AMD.

Approval for the new regimen is based on findings from the phase 4 ALTAIR study1, which tested a so-called “treat-and-extend” approach to AMD at 40 sites in Japan. In the study, 255 patients were given 3 monthly doses of aflibercept, then randomized to either 2-week (n = 124) or 4-week (n = 123) intervals for injections. Intervals could be shortened or lengthened based on clinical factors, and the maximum interval was 16 weeks. Best corrected visual acuity gains were similar between the 2 groups at 52 weeks, with a mean gain of 9.0 letters for the 2-week group and 8.4 letters for the 4-week group.

Said Michael Devoy, MD, chief medical officer of Bayer, “This new treatment regimen for Eylea has the potential to reduce the number of injections and clinic visits to less than 4 in the second year for certain neovascular AMD patients, while still maintaining strong visual outcomes and the ability to see.”  

Lower number of injections could also make a difference in costs. Aflibercept is more expensive than its fellow anti-vascular endothelial growth factor treatment bevacizumab, which is routinely used off-label to treat eye disorders. Recent reports have questioned whether aflibercept can compete with bevacizumab in terms of value; one paper from Europe suggested that, for aflibercept to be a justifiable alternative to bevacizumab, aflibercept should be reduced from €943 (approximately $1100) to €533 (approximately $622) per injection. 

In addition to pressure to compete on cost, aflibercept is also being targeted by a number of biosimilar developers; Momenta Pharmaceuticals and Mylan have announced that they will begin a pivotal clinical trial of their jointly developed M710, and Alteogen has announced that it will file and Investigational New Drug application for its ALT-L9.

Reference
Wai KM, Singh RP. Treat and extend dosing regimen with anti-vascular endothelial growth factor agents for neovascular age-related macular degeneration. Am J Ophthalmic Clin Trails. 2018;1(1): 1-6. doi: 10.25259/AJOCT-2-2018.

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