Sandoz announced that the FDA 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 20242.
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.
Keren Haruvi, President Sandoz North America said: “More than 30 million people in the US are living with retinal diseases that can lead to irreversible vision loss or blindness. With this expanded label, we’re broadening our ability to deliver affordable care to those impacted by these devastating diseases.”
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