Biosimilar Enzeevu Approved by FDA to Treat Neovascular Age-Related Macular Degeneration

neovascular age-related macular degeneration © pepermpron - stock.adobe.com

Sandoz announced today the FDA approval of biosimilar Enzeevu (aflibercept-abzv) for the treatment of neovascular age-related macular degeneration, according to the details of a news release published this morning. Enzeevu is interchangeable with reference medication Eylea (aflibercept) with unexpired exclusivity. The recommended dose of Enzeevu is a 2 mg intravitreal injection administered every four weeks for the first three months and then every eight weeks for two months.

This approval is based on clinical data from the Mylight study, an international study of 485 patients with neovascular age-related macular degeneration. The study lasted 52 weeks.

The most common adverse reactions reported were conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters and increased intraocular pressure which were all reported in 5% or fewer patients.

Neovascular age-related macular degeneration, also known as wet AMD, is the leading cause of age-related macular degeneration in those over the age of 50 in North America. The condition is caused by the abnormal growth of fragile blood vessels underneath the macula which is the part of the retina responsible for sharp vision. When these blood vessels break, they leak blood and other fluid into the eye which causes vision loss. Enzeevu prevents these blood vessels from growing.

“As sight disappears, so may a person’s connection to the world,” Jeff Todd, J.D., President and CEO of Prevent Blindness, said in the news release. “We welcome all treatment options that help maintain vision and meet the unique needs of the individual so those living with wet AMD can potentially maintain their independence longer. At this time, there is no cure for this disease and long-term treatment can be costly. Having more FDA-approved options, including biosimilars, can help make healthcare more person-centered and affordable.”

"The timing of the launch of Enzeevu in the United States could be impacted by a number of factors, including the progress and outcome of ongoing third-party patent litigations and any additional newly-initiated litigations, and any settlements that may be entered into in the future," a brand representative said in an email. "We cannot comment on pricing at this time."

Enzeevu is the fourth FDA-approved Eylea biosimilar. Other approvals include Ahzantive (aflibercept-mrbb) approved in June 2024, Yesafili (aflibercept-jbvf) and Opuviz (aflibercept-yszy) which were both approved in May 2024.

A biosimilar product has no clinically meaningful difference from the original, or reference, product approved by the FDA. Biosimilars are developed to potentially reduce costs and approve accessibility.