FDA greenlights Susvimo, a first-of-its-kind therapeutic approach for nAMD

The US Food and Drug Administration has approved Susvimo (ranibizumab) 100mg/mL for intravitreal use via ocular implant for the treatment of people with neovascular or “wet” age-related macular degeneration (nAMD) who have previously responded to at least two anti-vascular endothelial growth factor (VEGF) injections, the drug’s developer, Roche (ROG: SIX), announced on Friday.

Neovascular AMD is a potentially blinding condition that requires treatment with eye injections as often as once a month.

Ranibizumab is the active ingredient of blockbuster eye med Lucentis, which is sold by Roche in the USA and by fellow Swiss giant Novartis (NOVN: VX) elsewhere. Lucentis, which is an injectable, is already exposed to biosimilars, notably from Samsung Bioepis, a South Korean joint venture between Samsung Biologics and Biogen (Nasdaq: BIIB), whose Byooviz (ranibizumab-nuna) was approved by the FDA last month.