FDA Approves Eydenzelt, Additional Eylea Biosimilar

Celltrion’s biosimilar, Eydenzelt (aflibercept-boav), has been approved by the FDA as a treatment for adult patients with neovascular (wet) age-related macular degeneration (wAMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME) and diabetic retinopathy (DR), according to a company news release.

Eydenzelt is a biosimilar of Eylea (aflibercept). There are currently five other Eylea biosimilars:

• Opuviz: (aflibercept-yszy)
• Yesafili: (aflibercept-jbvf)
• Ahzantive: (aflibercept-mrbb)
• Enzeevu: (aflibercept-abzv)
• Pavblu: (aflibercept-ayyh)

This FDA approval was made using the results of the phase 3, 52-week trial that included 348 patients with DME. The primary endpoint was progressive improvement best-corrected visual acuity measured at week 8 from baseline. Researchers determined Eydenzelt was similar to Eylea’s efficacy, safety and immunogenicity rates.

The recommended starting dose of Eydenzelt for every indication is 2 mg administered via ophthalmic intravitreal injection by a physician, according to the prescribing information.

For patients with wAMD, 2 mg of Eydenzelt should be given every 28 days for the first three months, followed by 2 mg every eight weeks. However, some patients may need monthly dosing after the first 12 weeks. Additionally, patients may also be treated with one dose every 12 weeks after one year of effective therapy, depending on patient need.

For RVO patients, 2 mg of Eydenzelt should be given every 25 days, and DME and DR patients should receive 2 mg of Eydenzelt every 28 days for the first five injections, followed by 2 mg once every eight weeks. However, some patients may need monthly dosing after the first five months.

Adverse reactions were reported in at least 5% of patients treated with Eydenzelt. The most common were conjunctival hemorrhage, eye pain and cataracts.

Eydenzelt is a vascular endothelial growth factor (VEGF) inhibitor that blocks the activity of the VEGF protein, which, when left unchecked, causes excessive blood vessel growth.

Excessive blood vessels in the eye can lead to increased eye pressure, low vision, and, in extreme cases, blindness. This excessive growth is the hallmark of wAMD, RVO, DME and DR.

In wAMD, excessive blood vessels grow underneath the retina, which leak, thus damaging the macula, which is at the center of the retina. Patients may experience a sudden loss of central vision or straight lines might look distorted or wavy.

RVO occurs when a vein in the retina becomes blocked, which leads to a buildup of fluid in the macula due to leaky blood vessels, also referred to as a macular edema. Central vision loss associated with this disease may become permanent.

DME and DR can develop in people with diabetes if their blood sugar levels get too high. In DME, this causes damage to the blood vessels in the macula, the central part of the retina, which leak and cause a macular edema. Diabetic patients with DR experience blood vessel damage throughout the entire retina.

"Advanced age-related macular degeneration (AMD) is a leading cause of irreversible blindness and visual impairment in the world and nearly 20 million people in the U.S. are living with some form of age-related macular degeneration," David M. Brown, M.D., director of Retina Consultants of Texas Research Centers and co-chair of the Medical Leadership Board Retina Consultants of America, said in the news release. "Eydenzelt will be an important new addition to our options for the treatment of our patients with serious retinal diseases."