EYLEA (aflibercept): New Treatment for Wet ARMD Approved!

Eylea Approved for Wet Macular Degeneration

 

On Friday (11/20), the FDA approved Eylea for the treatment of wet macular degeneration.  Eylea is another anti-VEGF based treatment designed for intraocular injection.

Eylea has several names.  Eylea is also known as VEGF Trap-Eye.  The generic name is aflibercept.

Eylea = VEGF Trap-Eye = aflibercept

VEGF Trap-Eye Works With Fewer Injections

Several pivotal studies suggest Eylea and Lucentis to be equally effective in treating wet macular degeneration.  Of note, however, is that Eylea may require fewer injections to save the same amount of vision compared to its largest competitor, Lucentis.

Recommended dosing for VEGF Trap-Eye is an injection every 8 weeks following 3 initial monthly injections.  This is compared to Lucentis which was FDA approved for monthly injections.

Delivered by Eye Injection

As with the other macular degeneration treatments, Lucentis and Avastin, Eylea will also be delivered as an intraocular injection.  The most common side effects include:  subconjunctival hemorrhage (benign, but scary looking, bleeding outside the eye), eye pain, cataract, posterior vitreous detachment, vitreous floaters and increased intraocular pressure.

What Does This Mean? Not sure.  We have to wait and see.

Submitting a new drug to the FDA seems to involve some gamesmanship.  It seems that smart companies, such as Regeneron, apply for approval of drugs that offer a new advantage over already approved medicines.

Thus, Eylea’s major advantage seems to be that fewer injections are required to gain the same effect as Lucentis (and possibly Avastin).  Think of the convenience and cost savings!

At the very least, if true, fewer treatments means better compliance!

For the very acute readers, you noticed that I compared Eylea dosing to Lucentis dosing at every four weeks.  If you have followed the actual usage of Lucentis over the last few years, Lucentis is not always given every four weeks although Lucentis was FDA approved at every 4 week dosing.

In fact, the regimen seems to have diverged in some areas of the country from every four weeks to development of an “induction” period (mandatory series of shots) and then a “treat as needed” period.

The point is that once FDA approved, the way we use a drug may change as we learn through clinical “practice” what seems to work best.

So.  Let’s see what happens with the Eylea claim of 8 week dosing.  It would be a tremendous advantage to have a product that yields the same result, but requires fewer injections, that is, fewer trips to the office!

Fingers crossed.  I wonder if it will be twice the price of Lucentis?


 



Randall V. Wong, M.D.

Ophthalmologist, Retina Specialist
Fairfax, Virginia

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Comments

  1. Dr. Wong…this looks like encouraging news. It seems like a lot of the break throughs pertain to wet AMD. Do you think that the reason for this is that wet is more devasating than dry and it’s given a higher priority?

  2. Thank-you, Dr. Wong, for bringing this new treatment option to everyone’s attention.
    Several questions remain to be answered, including whether 6 injections per year of EYLEA indefinitely produce better results than using Lucentis only when needed.
    The trade off appears to be less frequent office visits when using EYLEA vs possibly less frequent injections with Lucentis when administered only when needed.
    Your approach to wait and see makes a great deal of sense.

  3. It is nice to hear about yet another drug for ARMD though its results are still to be seen. Comparison of its price with earlier drugs is another important factor.

  4. Dear Avery,

    I would agree, but I also think we will have some encouraging news about dry ARMD in a few years….awaiting nutritional data from AREDS 2.

    r

  5. Dear Jack,

    Thanks for you comments and your continued following.

    I just heard that, per treatment, Eylea will also be cheaper than Lucentis!

    Kudos to RGN!

    r

  6. George Bornhijm says:

    The question remains: What is the cost of one shot for a self pay patient?

  7. Dear George,

    The cost of the drug is about $1850. The cost of the injection can vary from surgeon to surgeon.

    For my specific charges, feel free to contact Chrissy, 703.273.2398.

    r

  8. Jane C Kehoe says:

    Had treatment with Eylea in right eye for long standing wet ARMD 7 wweks ago for the first time. Prior to that I received Avastin or lately,. Lucentis. I began the intaocular injections in 2005 with wonderful stability and results until I returned to my retina specialist 2 days ago and scored 20/60 on the eye chart. This is 20-30 foot(or point drop) from what I had been maintaining since 2005! I had consistently read at the 20/30 – 20/40 level for 6 1/2 years .My doctor just took me off Eylea and again gave me Lucentis again. I am frightened that my vision will not return to what it was prior to that Eylea shot. Does Dr. Wong have any thoughts on this?

  9. Dear Jane,

    Not an unusual story. Very common with wet ARMD as it is a progressive disease. The shots control “growth” and repeated shots can keep the disease in check. Often, after many shots, the disease slowly recurs…to the surprise of everyone.

    Keep up the faith. It may be possible for your “lost” vision to return, but your doctor is the best suited to guide your course.

    Stay in touch. Good luck.

    r

  10. Am I correct that unlike lucentis and avastin that are usually given “as needed”, eylea should be given every 8 weeks (after the initial 3 shot regiment) whether or not any bleeding is observed or do physicians administer it the same as lucentis and avastin on an as needed basis.

  11. Dear Rosie,

    Lucentis and Avastin are also recommended to be given on a regular schedule…for several years. That’s the official recommendation. With time we (doctors) often amend the official recommendation.

    Eylea is too new for us to figure out if 8 week dosing is as good as reported.

    Hope this was helpful.

    Randy

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  1. [...] month, the FDA approved Eylea (VEGF-Trap, aflibercept) for the treatment of wet macular degeneration.  The new drug does not need to be injected as often [...]

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