Sandoz Receives FDA Approval to Expand Enzeevu Label for Multiple Retinal Indications
The FDA has approved an expanded label for Sandoz's aflibercept biosimilar Enzeevu to include multiple retinal indications beyond its original approval for neovascular age-related macular degeneration. The product is expected to launch in the US in Q4 2026.
The US Food and Drug Administration has approved an expanded label for Enzeevu (aflibercept-abzv), to include multiple retinal indications. Enzeevu was originally approved by the FDA for the treatment of neovascular (wet) age-related macular degeneration (nAMD) in August 2024.
The most recent approval expands the Enzeevu label indications to include macular edema following retinal vein occlusion (RVO), diabetic retinopathy (DR) and diabetic macular edema (DME), along with the previously approved indication of nAMD. This expansion offers retina specialists a clinically-proven aflibercept biosimilar option to treat more patients across these retinal diseases.
More than 30 million Americans live with retinal diseases, which can lead to vision loss or blindness. The company's president for North America stated that with this expanded label, the company is broadening its ability to deliver affordable care to those impacted by these devastating diseases.
Sandoz plans to launch Enzeevu in the US in the fourth quarter of 2026, or earlier under certain circumstances.
This approval strengthens the company's position in ophthalmology, following the acquisition of the US biosimilar Cimerli (ranibizumab-eqrn) in 2024 and the European launch of Afqlir (aflibercept) in 2025. It also represents another step towards the overall strategic objective of capitalizing on a projected approximately USD 320 billion biosimilar market opportunity over the next 10 years.
Sandoz is committed to helping millions of patients access critical and potentially life-changing biologic medicines sustainably and affordably, with a leading global portfolio comprising 13 biosimilars and a further 27 assets in various stages of development.
The active ingredient in Enzeevu is aflibercept. Aflibercept is a recombinant fusion protein that binds to vascular endothelial growth factor A (VEGF-A) and placental growth factor (PlGF), inhibiting abnormal vessel growth. In patients with neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic retinopathy and diabetic macular edema, aflibercept is administered into the eye as an intravitreal injection helping to inhibit abnormal blood vessel growth and reduce vascular permeability associated with retinal diseases.