Alteogen Inc. (196170.KQ) Monday said it received positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for EYLUXVI, a biosimilar to Regeneron and Bayer's Eylea.
EYLUXVI, jointly developed with the company's subsidiary Alteogen Biologics Inc., has been recommended for approval in adult patients for the treatment of neovascular (wet) age-related macular degeneration (AMD), visual impairment due to macular oedema secondary to retinal vein occlusion, visual impairment due to diabetic macular oedema, and visual impairment due to myopic choroidal neovascularisation.
The positive CHMP opinion is based on data included from the ALT-L9 Phase 3 study showing equivalent efficacy and comparable safety, immunogenicity, and pharmacokinetics profiles between EYLUXVI and reference Eylea in patients with wet AMD.
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