Fda approves new treatment for diabetic retinopathy

#1

WRITTEN BY: Todd Boudreaux

On Tuesday, May 13, Regeneron Pharmaceuticals announced that the FDA has approved EYLEA (aflibercept) to treat all stages of diabetic retinopathy. “With today’s FDA approval, EYLEA has once again set a high bar for the treatment of diabetic eye diseases,” said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer at Regeneron.

Diabetic retinopathy is a progressive disease that occurs in people with diabetes, caused by changes in the blood vessels of the retina. The complications generally start as non-proliferative diabetic retinopathy, when prolonged high blood sugar causes loss of capillaries and thus reduced oxygen. This triggers a repair response that stimulates new blood vessel growth in an attempt to bring more oxygen to the choking retina. Proliferative diabetic retinopathy arises from the lack of oxygen, when new retinal blood vessels form in a disorganized way, frantically trying to make up for the lost oxygen. This chaotic proliferation could eventually pull the retina off of the back of the eye, causing complete blindness.

EYLEA works by inhibiting the vascular endothelial growth factor (VEGF) and joins other anti-VEGF injections like Avastin (bevacizumab) and Lucentis (ranibizumab) as approved treatments for diabetic retinopathy. Notably ELYEA is the only anti-VEGF approved for two different dosing options to treat diabetic retinopathy, every four weeks or every eight weeks.

It is estimated that eight million people in the U.S. have diabetic retinopathy, and the disease is the leading cause of blindness among working-age American adults. The approval was based on the results of the PANORAMA trial, a one-year phase 3 trial involving 402 patients at varying stages of diabetic retinopathy. The results were impressive — 80% of patients receiving EYLEA every eight weeks showed significant signs of improvement, compared to just 15% in the control group.

“Millions of people have been robbed of their vision due to the progression of diabetic retinopathy,” said David Brown, M.D., F.A.C.S., an investigator for the PANORAMA trial and Director of Research at Retina Consultants of Houston. “The prevention of worsening diabetic retinopathy with EYLEA provides a compelling rationale for early treatment of patients with this disease, particularly since eyes dosed with EYLEA as infrequently as every 16 weeks showed significant improvements in the pivotal PANORAMA trial.”

It is recommended that people living with diabetes have annual eye exams to check for signs of diabetic retinopathy, as early intervention and treatment are key in reducing the risk of blindness.

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#2

“Intravitreal injections, including those with EYLEA, have been associated with endophthalmitis and retinal detachments”

“The most common adverse reactions (≥5%) reported in patients receiving EYLEA were conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and intraocular pressure increased.”

That is scary! I hate the thought of having any unnecessary procedures done to my eyes. I was apprehensive about my first cataract surgery, but that went so well, I was thrilled with the results and subsequently got the other done a couple years later as that eye got a bit cloudy. I have lots of floaters which a retinal specialist said he could eliminate with a vitrectomy but upon hearing about all the complications I decided to live with the floaters.

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#3

Recently, they found a few new blood cells growing at the back of my eyes. I am annoyed because they were totally fine in August of 2017, which is about the time I started dramatically improving my hba1c, but I guess that’s just how things work out sometimes. My retina guy said that my case was super borderline as to whether I should do treatment or not, and we started talking about injections vs. Lasers, but then I got pregnant and we decided to hold off on treatment to see if the problem gets worse with the pregnancy (plus, the injection can pass the placenta barrier). Has anybody had the injections? He said it was a super new treatment and he’d only been doing it a year, but that was the one he would recommend. The only super scary thing is he also said theres a 1 in 2000 chance of getting an infection and going completely blind, and people often need more than 1 treatment, so every treatment carries that 1 in 2000 risk (which I know is super low…but blindness is scary).

#4

I’ve been taking these injections for about two years now. They have been used for macular degeneration for quite some time. I started on injections every four weeks, but I’ve about doubled the time between injections since they have been working well. I don’t have diabetic retinopathy, but the medications are the same. A good deal of effort goes into avoiding infections. Eye drops are used to prevent infection and everyone wears face masks, including the patient.

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#5

How easy and painless are the injections? I’m the type that blinks 3 times before they finally get a good picture, and the technician had to hold my eyelids open at the last scan. I’m trying to figure out what I should expect, but most websites just talk about the lasers. If it’s a choice, I want to be as informed as possible.

#6

Hi @BeckyZ

This is a tough question, because everyone reacts differently to pain and/or perceived pain. But to me, the eye injections are just a nuisance like a lot of the other things we do as diabetics.

That said, we could reach deep into our anxiety closet and build expectations up as to how bad this could be! Here’s how I would describe the process. Note that different doctors may have variations in the procedure.

First, you get multiple eye drops. I believe the purposes for those are 1)antiseptic, 2)numbing and 3)pupil dilation. The latter is just so the doctor can see if there are any issues after the injection. There never have been.

Next you have a face mask put on — like the paper mask painters wear (but probably 10x the cost!) Next, you have some gel put in your eye. It feels cool — no pain at all. This is done several times. They put a sticker on your forehead over the eye to be treated. In my office, assistants do these steps and you wait perhaps 10 minutes or so for the doctor.

The doctor comes in and uses a device that keeps your eyelids open. It also feels cool, no pain or discomfort. Next, she takes something that looks like a pen and touches it to my eye. Don’t know what this is — marking the spot or applying something at the injection site? Anyway, not the slightest bit painful. Finally she does the actual injection. This goes into the white of the eye, not the colored part.

You do feel a slight dull pain for just a second on insertion. But it is extremely mild and it only lasts a fraction of a second. Once the needle is in, there is no pain at all. The medication is slowly injected over perhaps 20 seconds or so? The eyelid clamp is removed and your eye is washed out. You’re done!

The eye may feel just a bit scratchy for the rest of the day. There is an OTC gel that you can apply to help, if that happens. It’s thick though, so it’s a perfect excuse for a nap! This doesn’t always happen either.

To me, the biggest factor is the “OMG, they are going to stick a needle in my eye!” anticipation. Once you’ve been through the process, it just isn’t a big deal.

Don’t know if this is a choice for you, but best of luck if you do go this route.

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#7

I agree that the injections are not as big of a deal as they seem. Prior to having retinopathy, I hated anything done to my eyes, to the point of being difficult to administer eye drops and the glaucoma test to, and now I get injections just fine, so that should tell you something. Some doctors use the clamp and some don’t (I find the clamp more annoying than the injection, so I’m glad my current one doesn’t). It’s uncomfortable and not fun, and my eye feels irritated the rest of the day, but it’s totally tolerable. I also have never needed to wear any sort of face mask when getting my injections, nor stickers. I think those parts vary by office.

Lasers on the other hand, do permanent damage to your vision. It works by basically killing parts of your retina so the blood vessels stop proliferating to feed those sections. I still see mostly ok, but my night vision is now noticeably worse from when I had mine done (loss of peripheral vision, which lasering tends to entail, also means loss of rods, which are your black/white vision, which is what you use for night vision). I needed it at the time, but now very strongly prefer continued treatment with injections as needed vs more laser for that reason. Also laser treatment actually hurts much much more than injections.

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#8

Also, I get my injections every few months or so—just because they are approved for more often doesn’t mean that’s necessarily what you’ll do. At this point I do an injection, we watch the eye carefully, and do another when/if blood vessels seem to activate again. It works because I continue to go in often to monitor, at least every 3 months. Sometimes it’s been 6-8 months between injections. You’ll have to figure out with your doctor the approach that works for you if you go with injections.

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#9

Thanks! The information you gave me will definitely help in making my decision. The doctor was already recommending the injection over the laser, so I think I’ll probably take the injection when the time comes.

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#10

I have had dozens of injections in both eyes over the past ten years. They aren’t fun but they do work. I have had both Avastin and Eyelea. I think the Eyelea has a slightly longer duration.

I can say this, I don’t like the injections but I hate the eye bleeds even more.

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