CHMP issues positive opinion for Alteogen’s aflibercept biosimilar, EYLUXVI

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The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for EYLUXV, a biosimilar referencing Eylea (aflibercept). EYLUXV was co-developed by Alteogen and its subsidiary Alteogen Biologics Inc.

According to the CHMP opinion, EYLUXVI has been recommended for approval in adult patients for the treatment of neovascular (wet) age-related macular degeneration (AMD), visual impairment due to macular edema secondary to retinal vein occlusion (branch RVO or central RVO), visual impairment due to diabetic macular edema (DME), and visual impairment due to myopic choroidal neovascularization (myopic CNV).

Soon-Jae Park, PhD, CEO of Alteogen, commented on the CHMP opinion, stating, "We are pleased to receive a positive CHMP recommendation for EYLUXVI. This marks a significant milestone for Alteogen. We will provide a new, accessible treatment option for patients suffering from devastating ocular diseases such as wet age-related macular degeneration.”

According to the company, the CHMP opinion was based on the “totality of evidence comprising a comprehensive analytical, non-clinical, and clinical data package.”

Furthermore, a randomized, double-masked, parallel-group, multicenter phase 3 study, conducted by Alteogen Biologics, demonstrated equivalent efficacy and comparable safety, immunogenicity, and pharmacokinetics (PK) profiles between EYLUXVI and reference aflibercept in patients with wet AMD.

The study was conducted at 79 centers in 12 countries from June 2022 to February 2024, including follow-up through 52 weeks. In the trial, 431 participants with wet AMD were randomized 1:1 to receive either ALT-L9 (n = 216) or Eylea (n = 215). The primary efficacy endpoint of the study was the change from baseline in best corrected visual acuity (BCVA).

Reference:

1. Alteogen receives positive CHMP opinion for aflibercept biosimilar, EYLUXVI (ALT-L9). Published July 28, 2025. Accessed July 28, 2025. https://www.prnewswire.com/news-releases/alteogen-receives-positive-chmp-opinion-for-aflibercept-biosimilar-eyluxvi-alt-l9-302514688.html