Alteogen’s EYLUXVI Receives Positive CHMP Opinion

Alteogen and its subsidiary, Alteogen Biologics Inc., have announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for EYLUXVI, a biosimilar referencing aflibercept (Eylea).

Indications and Scope of Approval

The CHMP has recommended EYLUXVI for approval in adult patients for the treatment of several serious retinal diseases, including neovascular (wet) age-related macular degeneration (AMD), visual impairment caused by macular edema secondary to retinal vein occlusion (both branch RVO and central RVO), diabetic macular edema (DME), and visual impairment resulting from myopic choroidal neovascularization (myopic CNV).

CEO Statement on CHMP Milestone

Dr. Soon-Jae Park, CEO of Alteogen, expressed optimism about the committee's opinion:
"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.”

Clinical and Scientific Evidence Supporting the Recommendation

The positive opinion from CHMP is based on the totality of evidence, which includes a full suite of analytical, non-clinical, and clinical data. A pivotal phase 3 study, conducted by Alteogen Biologics, played a key role in this recommendation.

This randomized, double-masked, parallel-group, multicenter trial demonstrated that EYLUXVI is equivalent in efficacy and has a comparable safety, immunogenicity, and pharmacokinetic (PK) profile to the reference product, Eylea, in patients with wet AMD.

Phase 3 Study Design and Results

The phase 3 study was conducted between June 2022 and February 2024 and included a 52-week follow-up period. It took place across 79 clinical sites in 12 countries and enrolled a total of 431 patients diagnosed with wet age-related macular degeneration. Participants were randomized in a 1:1 ratio, with 216 patients receiving ALT-L9 (EYLUXVI) and 215 patients receiving the reference product, Eylea. The primary efficacy endpoint of the study was the change from baseline in best corrected visual acuity (BCVA).

The trial results confirmed therapeutic equivalence, validating EYLUXVI as a potential new option for managing sight-threatening retinal diseases.

Regulatory Outlook

The CHMP’s positive opinion positions EYLUXVI for formal marketing authorization in the European Union, potentially offering clinicians and patients a cost-effective alternative to Eylea without compromising efficacy or safety.