The Latest on Eylea: A Leading Treatment for Diabetes-Related Retinopathy
Key takeaways:
- The FDA has recently approved 3 biosimilars for Eylea called Ahzantive,Yesafili, and Opuviz.
- As biosimilars, they are almost identical to Eylea and have the same clinical effects.
- Research suggests that Eylea, a medication for diabetic retinopathy, reduces the risk of more serious eye complications when used for prevention.
As many as 60% of patients may not know they have some form of early-stage diabetes-related retinopathy, according to Dr. Jennifer Sun, co-chair of the Diabetic Retinopathy Clinical Research Network.
Results from a clinical trial focused on prevention of diabetic retinopathy examined whether Eylea, a common therapy in the US used to treat several eye conditions including diabetes-related eye disease, reduces vision impairment from diabetic retinopathy.
Eylea is an approved treatment for diabetic macular edema (DME) and diabetes-related retinopathy (DR), two of the eye complications associated with diabetes. Eylea is an anti-VEGF therapy, meaning that the drug blocks VEGF, a protein that is necessary for new blood vessel growth. The medication is injected into the eye by an ophthalmologist every four to 16 weeks depending on the severity of the eye disease.
Eylea HD was approved in August 2023 for diabetic retinopathy. Eylea HD is a higher dose version that can be administered less frequently.
Does early Eylea treatment of diabetes-related retinopathy result in better vision later on? The answer may not yet be clear. While Eylea was found to reduce specific vision-threatening complications, it did not meaningfully improve vision outcomes in the published study.
How did the trial work and what were the key findings?
The trial looked at 328 adults with early-stage diabetes-related retinopathy (also called non-proliferative diabetes-related retinopathy) and excellent vision. At the beginning of the study, about half of the eyes received Eylea injections every 16 weeks, and the other half received a placebo injection (which included no medication). The preliminary data were reported through two years. The study will continue for a total of four years.
The researchers were studying two main outcomes in these eyes:
- Changes in the anatomy of the retina (for evidence of either a more advanced stage of diabetes-related retinopathy, called proliferative diabetes-related retinopathy, or the development of swelling called center-involved diabetes-related macular edema). These can be thought of as structural changes in the eye.
- A functional difference in participants’ ability to see, known as their visual acuity.
The trial found that Eylea led to improved anatomical outcomes and reduced the risk of more serious eye complications:
- Eylea reduced the risk of developing complications by 68% when compared to the placebo. The probability of developing any complication was 16% in the Eylea group and 44% in the placebo group.
- Individually, participants taking Eylea were 66% less likely to develop more advanced stages of diabetes-related retinopathy (proliferative diabetes-related retinopathy) and 64% less likely to develop macular edema with vision loss.
- People receiving placebo injections were five times more likely to need additional treatment (with Eylea) with worsening of the eye disease.
- There was no difference in the vision quality of either group after two years (excellent vision in 75% of the treatment group and 72% of the placebo group).
The four-year results of the trial will be important in determining whether the higher rate of complications in the placebo group might eventually lead to more vision loss in that group. If this is the case, treating diabetic retinopathy in its earliest stages with Eylea may present a long-term benefit for vision.
There are several treatment options for diabetes-related eye disease, including oral medications, laser treatments for the eyes, and therapies like Eylea. Increasingly, surgical techniques are being used for less advanced stages of diabetes-related eye disease. Other novel strategies are also being investigated to avoid needing regular injections into the eye.
FDA approves new Eylea biosimilars Ahzantive, Yesafili and Opuviz
In May 2024, the FDA approved Ahzantive, Yesafili, and Opuviz as biosimilars for Eylea.
Biosimilars are similar versions of the original medication that have the same clinical safety and efficacy. Yesafili and Opuviz are also interchangeable, meaning that they can be substituted at the pharmacy without consulting the doctor who prescribed the medication. Ahzantive is not interchangeable.
Biosimilars tend to be less costly than the original products, though no information regarding the pricing of the biosimilars is available at this time.
The bottom line
More information is needed before Eylea can be considered for use as a widespread tool to prevent worsening of diabetes-related retinopathy. Dr. Sun’s bottom line for clinicians and patients?
“With regular follow-up and rigorous evaluation, the chances of continuing to have good vision, even with severe non-proliferative diabetic retinopathy and moderate nonproliferative diabetic retinopathy, are excellent. I don’t think this study says that early treatment should be routinely given yet. It is important to hang tight and wait for four-year results.”
The most important action people with diabetes can take is to have an annual dilated eye exam, in addition to managing glucose, blood pressure, and cholesterol levels. If diabetes-related eye disease worsens, there are a number of options that can be used to prevent vision loss.
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