New Biosimilar for Diabetes-Related Eye Disease Hits U.S.

Written by Ted Samson

Posted on September 1, 2026

Feel better informed on diabetes and get real support from your community.

A new biosimilar of Eylea, a brand-name form of aflibercept, is now available in the United States. Biosimilars are medications that are highly similar to FDA-approved biologic drugs, with no clinically meaningful differences in safety or effectiveness.

Aflibercept is a treatment for diabetic macular edema (DME) and diabetic retinopathy. The new biosimilar, aflibercept-jbvf (Yesafili), was approved by the U.S. Food and Drug Administration (FDA) in May 2024, but a delay tied to patent litigation kept it off the U.S. market.

The launch gives eye specialists another aflibercept option for diabetes-related eye disease. Biosimilars may also help expand access and lower treatment costs, although insurance coverage and out-of-pocket costs can vary.

🗳️ Has a healthcare professional said you have diabetes-related eye disease, such as diabetic retinopathy or diabetic macular edema (DME)?

Yes, I have diabetes-related eye disease.

No, I’ve been checked, and none was found.

I haven’t been checked for diabetes-related eye disease.

I’m not sure.

What Is Yesafili?

Yesafili is an anti-vascular endothelial growth factor (anti-VEGF) treatment given by injection into the eye. As a biosimilar, Yesafili is highly similar to Eylea and has no clinically meaningful differences in safety or effectiveness, according to the FDA.

VEGF is a protein that can cause abnormal blood vessels to grow and leak fluid in the eye. By blocking VEGF, aflibercept products can reduce abnormal blood vessel growth and leakage, helping protect the retina and preserve vision.

What Did Clinical Trials Show?

The FDA approved Yesafili after reviewing clinical, laboratory, and other scientific evidence. An important part of this review was the INSIGHT phase 3 clinical trial, which included 355 adults with DME. Participants received either Yesafili or Eylea so researchers could compare how well the treatments worked and how safe they were.

Key findings from the trial included:

Equivalent vision improvement — By week 8, both groups showed similar gains in best-corrected visual acuity (BCVA). BCVA measures the sharpest vision a person can achieve with the best possible glasses or contact lens correction.
Long-term consistency — Through 52 weeks, changes in retinal thickness remained similar between the two groups. People also received about the same number of injections.
Safety and immunity — Safety and immune responses were comparable.

These results support Yesafili as a highly similar alternative to Eylea for people living with DME.

What Are the Possible Side Effects?

Like all treatments, Yesafili can cause side effects. The most common side effects reported with aflibercept products include:

Conjunctival hemorrhage (bleeding on the surface of the eye)
Eye pain
Cataracts (clouding of the eye’s lens)
Vitreous detachment
Vitreous floaters
Increased pressure inside the eye

Serious problems can happen after an injection, including endophthalmitis (a serious infection inside the eye), retinal detachment, and retinal vasculitis, which is inflammation of the blood vessels in the retina.

Eye specialists also monitor for increases in eye pressure and a potential risk of blood clots, which can lead to problems such as stroke or heart attack.

Why Does the Launch Matter for People With Diabetes?

DME can cause blurry or distorted vision because fluid builds up in the macula, the part of the retina responsible for sharp central vision. Treatment with anti-VEGF injections often involves repeated injections and follow-up visits.

Yesafili is now the second aflibercept biosimilar commercially available in the U.S. Before its launch, Pavblu was the only marketed Eylea biosimilar in the country. That gives eye practices another product to evaluate and may increase competition.

The FDA says biosimilars may cost less than their reference products, but Yesafili’s availability doesn’t guarantee lower prices or coverage.

The treatment won’t be the right fit for everyone. An eye specialist may use eye exams and retinal imaging to look at how much the eye is affected, along with your past treatments, other health conditions, and insurance coverage or access, to decide whether Yesafili may be a good option for you.

Join the Conversation

On DiabetesTeam, people share their experiences with diabetes, get advice, and find support from others who understand.

Have you discussed a biosimilar eye injection with your eye specialist, or are you considering treatment for DME or diabetic retinopathy? Let others know in the comments below.

References