The FDA has granted Enzeevu (aflibercept-abzv, Sandoz) approval for the treatment of neovascular age-related macular degeneration (nAMD) also known as wet AMD. Specifically, the 2-mg vial kit and pre-filled syringe for intravitreal injection is indicated to improve and maintain visual acuity. The FDA’s approval is based on comprehensive analytical and preclinical in vitro study data as well as clinical data from Arnaldo et al’s international Mylight study, which examined 52-week results of treatment.

Contraindications include ocular or periocular infection, active intraocular inflammation and hypersensitivity. Sandoz says it expects Enzeevu to be a key biosimilar growth driver in the United States. The timing of the drug’s launch will be dependent on several factors, according to a Sandoz press release, including the progress and outcome of pending or potential future related litigations or any potential settlements.