EMA — authorised 13 January 2025
- Application: EMEA/H/C/006607
- Marketing authorisation holder: Formycon AG
- Local brand name: Ahzantive
- Indication: Ahzantive is indicated for adults for the treatment of • neovascular (wet) age-related macular degeneration (AMD) (see section 5.1), • visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) (see section 5.1), • visual impairment due to diabetic macular oedema (DME) (see section 5.1), • visual impairment due to myopic choroidal neovascularisation (myopic CNV) (see section 5.1).
- Pathway: biosimilar
- Status: approved
The European Medicines Agency (EMA) approved AHZANTIVE, a biosimilar, for the treatment of adults with neovascular (wet) age-related macular degeneration (AMD), visual impairment due to macular oedema secondary to retinal vein occlusion, diabetic macular oedema (DME), and myopic choroidal neovascularisation (myopic CNV). This approval was granted on 13 January 2025. The marketing authorisation holder is Formycon AG, and the local brand name is Ahzantive.