Enzeevu is designed to improve and maintain visual acuity in patients suffering from nAMD, a condition that is a primary cause of vision impairment among individuals over 50 years.
Enzeevu’s active component is aflibercept. Aflibercept is a recombinant fusion protein that attaches to vascular endothelial growth factor A (VEGF-A) and placental growth factor (PlGF), preventing aberrant vessel development.
In individuals with nAMD, aflibercept is injected into the eye to enhance visual acuity and slow disease progression.
The FDA’s approval of the asset is based on a comprehensive body of evidence, which includes analytical, preclinical in vitro studies, and clinical data from the Mylight study.
The US regulator also provisionally determined that Enzeevu may be interchangeable with its reference medicine, subject to the expiry of an existing exclusivity period for the first interchangeable biosimilar products.
The launch of Enzeevu is contingent on various factors, including the progression and outcomes of ongoing or potential future litigation or potential settlements.
Sandoz chief scientific officer Claire D’Abreu-Hayling said: “nAMD, or wet AMD, continues to be a leading cause of vision impairment in patients over 50 years in North America. This condition affects millions of people, leading to significant challenges in their daily lives due to the progressive loss of central vision.
“The US approval of Enzeevu is a key milestone in Sandoz efforts to significantly improve the lives of patients impacted by this incurable disease.”
Earlier this year, Sandoz concluded the acquisition of the Cimerli (ranibizumab-eqrn) business significantly bolstered its ophthalmology portfolio in the US.
This move, which included the integration of field force employees, is claimed to have laid a solid foundation for the anticipated introduction of Enzeevu to the market.