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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
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.
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?
A detached retina is potentially blinding. The retina is the light sensitive tissue that lines the inside of the eye. A retinal tear or hole usually leads to a retinal detachment. Floaters can sometimes be the earliest, and only, symptom. Many times there is little warning and a retinal detachment usually occurs without trauma.
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Randall V. Wong, M.D.
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Randall V. Wong, M.D.
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