The FDA has approved Yesafili (aflibercept-jbvf) and Opuviz (aflibercept-yszy) as interchangeable biosimilars to Eylea (aflibercept). Aflibercept products inhibit vascular endothelial growth factor (VEGF), preventing abnormal blood vessel growth in the eye, thereby helping to preserve vision by reducing or slowing damage to the retina.

Treatment Applications

Both Yesafili and Opuviz are approved to treat:

• Neovascular (wet) age-related macular degeneration
• Macular edema following retinal vein occlusion
• Diabetic macular edema
• Diabetic retinopathy

These biosimilars are administered intravitreally (in the eye) as a 2 mg (0.05 mL of 40 mg/mL) injectable solution according to the recommended dosing regimens.

Understanding the Conditions

Neovascular (Wet) Age-Related Macular Degeneration (AMD)

Wet AMD affects the macula, the central part of the retina responsible for sharp vision. In this condition, abnormal blood vessels grow under the macula and leak blood and fluid, leading to damage that can cause distorted or blurry vision, and in severe cases, significant vision loss. This condition typically affects adults over 65 and can progress rapidly if untreated.

Macular Edema Following Retinal Vein Occlusion (RVO)

RVO occurs when a vein carrying blood away from the retina is blocked, causing increased pressure and leakage that leads to macular swelling. This can result in blurry or distorted vision and, in severe cases, vision loss. It is more common in adults over 50.

Diabetic Retinopathy

Diabetic retinopathy affects people with diabetes, where high blood sugar levels damage the retina's blood vessels. Initially, these vessels leak fluid or blood, causing blurry vision or dark spots. In advanced stages, new blood vessels grow and bleed into the eye, causing floaters or vision loss. The risk increases with the duration of diabetes.

Diabetic Macular Edema (DME)

DME occurs in people with diabetic retinopathy, where fluid leaks into the macula, causing blurry or distorted vision. It primarily affects those with uncontrolled or long-standing diabetes.

Biosimilar and Interchangeable Biosimilar Approval

Biosimilars are highly similar to FDA-approved biological products, with no clinically meaningful differences. Interchangeable biosimilars can be substituted for the reference product at pharmacies without consulting the prescriber, subject to state laws. FDA's approval of Yesafili and Opuviz was based on comprehensive scientific evidence, including analytical comparisons and clinical studies demonstrating their similarity to Eylea in terms of efficacy, safety, and immunogenicity.

Safety Information

The side effects of Yesafili and Opuviz are consistent with those observed with Eylea, including conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and increased intraocular pressure. Additional risks include hypersensitivity, endophthalmitis, retinal detachments, retinal vasculitis, increased intraocular pressure, and thromboembolic events.

Highlights

• FDA Approval: Yesafili and Opuviz approved as interchangeable biosimilars to Eylea.
• Treatment Areas: Neovascular (wet) AMD, macular edema post-RVO, diabetic macular edema, and diabetic retinopathy.
• Condition Details: Detailed descriptions of each condition treated by the biosimilars.
• Approval Basis: Comprehensive scientific evidence demonstrating no clinically meaningful differences from Eylea.
• Safety Profile: Side effects and risks consistent with Eylea.