Is Eylea Going to Replace Lucentis and Avastin?

Eylea (aflibercept, Regeneron) just received FDA approval for treatment of Wet Macular Degeneration.  It is being billed as better than Lucentis and Avastin because “it lasts longer.”  Is this true?  Will it replace Lucentis and Avastin?  What are early issues with using this medication?

Eylea works by a similar mechanism as Lucentis and Avastin (blocks Vascular Endothelial Growth Factor or VEGF).  Instead of being an antibody to the VEGF molecule, it is a fusion protein consisting of portions of the receptors for the VEGF molecule (VEGFR-1, VEGFR-2), thereby binding and blocking VEGF.

The results of their pivotal FDA studies (VIEW 1 and VIEW 2) showed that 1)Eylea injected every month, 2)Lucentis injected every month, and 3)Eylea injected every month for three months then every two months after that had very similar results at one year (see Table below):

To summarize, the three groups gained between 8.4 and 9.25 letters (almost 2 lines of vision) at one year.  There were no significant differences between them.  Biggest problem:  there was no comparative group of Lucentis every 2 months.  So… we really don’t know if Lucentis every 2 months would be the same.

So, there is no clear evidence that this new drug is more effective than Lucentis.  The price is also similar to Lucentis (about $1,800 per injection).  Even though it is approved for every two months, it can be used every month.  Their Year 1 to Year 2 extension study (using treatment when there is leakage), showed Eylea patients needed an average of 4.2 injections while Lucentis patients needed 4.7 injections (not a big difference).  Also, when treatment was done “as needed” instead of on a regular monthly schedule, patients lost about a letter of vision.

Best use for this drug:  current Lucentis or Avastin patients that are not effectively controlled on current regimens

Biggest problem:  Because this drug is new, it does not yet have its unique “J code” for reimbursement.  As a result, it may be tricky to get your insurance company to cover it and you may be stuck with a big bill.  This will likely improve with time when it obtains a J code.

BOTTOM LINE:  Eylea is a new drug for Wet AMD that may be helpful in patients that do not completely respond to Lucentis and Avastin.  It has the potential to last longer than Lucentis and Avastin, but so far the evidence is not terribly strong and the visual acuity results are not different.  Currently, obtaining insurance coverage for the drug may be challenging as it does not yet have a J-Code.