FDA Delays Decision on VEGF Trap Eye

VEGF Trap-Eye was not approved by the FDA for the treatment of wet macular degeneration.  The parent company, Regeneron, was hopeful to gain FDA approval last week, but the FDA delayed its decision until November of this year.

VEGF Trap-Eye Treats Wet Macular Degeneration

VEGF Trap-Eye, or aflibercept, is another anti-VEGF drug formulated to treat wet macular degeneration.

Like its competitors, aflibercept is designed to neutralize the effects of the Vascular Endothelial Growth Factor a key component in the pathway of wet macular degeneration.  It, too, will be administered as an injection into the eye as are Lucentis and Avastin.

If you recall, Lucentis is FDA approved for wet macular degeneration.  Avastin is not FDA approved, but is commonly used by retinal specialists, hence, it has become the standard of care.

Fewer Injections into the Eye

Unlike its competitors, aflibercept may be injected less frequently than its competitor, Lucentis.  Instead of monthly injections, VEGF Trap-Eye may be injected every 2 months!

What Does this Mean? There is a potential new drug near FDA approval for the treatment of wet macular degeneration.

Assuming that Eylea (the proposed trade name) is just as effective as Lucentis, there are two particular advantages to the new drug:  cost and frequency of administration.

Eylea will be the third drug to be used for wet ARMD, but only the second that is FDA approved (Lucentis is FDA approved, but Avastin is used “off label”).  It is conceivable that that Eylea will be priced between the two drugs…

Fewer injections means fewer office visits, fewer complications and this means….cost savings (thus an argument to increase the price compared to Lucentis!).

Personally, I think there is room for a drug that doesn’t have to be given monthly.  There are substantial savings to realize;  costs in terms of office visits, costs of injections and the intangible costs…the costs involved to have a family member or friend accompany the patient…

 

 

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Comments

  1. Thanks Doc Randy!

    If I understand then, the epithilial cells that have grown across, ( or under my retina,) are similar to those that contribute to wet macular degeneration? Or are these two diseases effectively the same?

    These various drugs reduce the cells and improve vision that way? ( Doing my best to follow this:)

    Dave

    Very much appreciate the information.

    Dave

  2. Stay safe with the upcoming hurricane. We’re getting it here in New York. :(

    See you next month.

  3. Dear John,

    See you next month. Sounds like most of us “escaped” especially NY.

    r

  4. Hi-I was just diagnosed with acute AMD 2 weeks ago. Had an intraocular injection of Avastin, returned for a repeat occular scan that showed some improvement after 1 week, and was advised that I would need to have roughly monthly injections. Not a happy thought for me! Does anyone know what the cost of the bi-monthly product of Eylea might be if it is approved. Thank you.

  5. Hello again-I recognized that I failed to tell you that I was diagnosed with WET AMD. I am 62 y/o caucasian male. Thank you for whatever advise you can give me. I was somewhat concerned about the Avastin when I read that 5 patients had blindness reported yesterday; however, it seems to have been linked with the preparation of the drug at 2 specific pharmacies. Any insight related to this would also me appreciated.

  6. Dear CJ,

    My best guess is that Eylea is going to be priced at least as much as Lucentis, but the injection rate may be lower, that is, instead of monthly injections, Eylea may be injected every 8 weeks.

    r

  7. Dear CJ,

    You are absolutely right! The infections have nothing to do with the drug….just the preparation. Thanks for pointing that out! It is scaring so many people!

    r

  8. Thank you so much for your feedback!
    Do you have experience with using Avastin at a frequency that might be extended to a longer duration than monthly injections with patients who respond to initial therapy? I have read on line that there is some discussion of use on a prn basis. I am unsure though how the patient might be able to determine their individual need for a prn dose unless the use of the Amsler grid on a daily basis might be helpful. This came on, in my case, so suddenly that I can date the onset of clinical symptomatology to perhaps a 24 hours basis. I would appreciate your insight into this question.

  9. Hi again-one additional question that I would hope you would comment on:
    I had the onset of wet AMD in one eye. The other eye appears have a normal exam.
    I have heard that there is a suggestion that the “good eye” has a roughly 50% chance on developing wet AMD within 5 years and 100% chance of having it within 10 years. Has that been compatible with your knowledge regarding this disease?
    Thank you so much for your time in addressing my question.

  10. The 2nd medication FDA approved? Pegaptanib and verteporfin are also FDA approved.

  11. Anonymous says:

    I completed four years in a clinical trial for VEGF-Trap for AMD. Results: one eye was administered two shots (1 moth apart) and has not needed treatment in 4 1/2 years. The other eye, formerly dry MD, regressed to AMD two years into the trial; it too had two shots administered. Unfortunately, that eye regressed in April of this year. It has been treated with two shots of Avastin, with some little improvement. But my eyesight remains decent; I can drive and read, albeit more slowly. There seems to be some disagreement among retinal specialists as to whether the eye builds up a resistance to Avastin, or not. Needless to say, I am unhappy about the FDA postponement of approval. One wonders if there is any way to prod the FDA.

  12. JS,

    Whoops, my mistake! I forgot about Macugen and didn’t count verteporfin as it’s not anti-VEGF!!

    Thank you!

    r

  13. Dear A,

    I think you will be hearing some good news regarding VEGF-Trap in the next few weeks!

    Randy

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