Therapeutic Equivalence of Eyluxvi (Aflibercept) to Eylea in Neovascular Age-Related Macular Degeneration: ALTERA Trial (Randomized)

Introduction This study aimed to evaluate the efficacy and safety of Eyluxvi, an aflibercept biosimilar, compared with reference Eylea in patients with neovascular age-related macular degeneration (nAMD). Methods This phase 3, multicenter, randomized, double-masked, parallel-group study enrolled 431 patients at 79 sites across 12 countries. Patients were randomized 1:1 to receive intravitreal Eyluxvi or Eylea (2 mg) every 4 weeks through week 12, then every 8 weeks through week 48. The primary endpoint was change from baseline in best corrected visual acuity (BCVA) at week 8. Results The week 8 least-squares mean BCVA change was 5.771 letters with Eyluxvi vs 7.863 letters with Eylea (difference − 2.092 [95% confidence interval (CI) − 3.431 to − 0.753]). This equivalence was maintained through week 52. Week 52 adjusted mean changes were comparable for central subfield thickness (CST) (difference − 4.742 μm [95% CI − 22.006 to 12.521]) and choroidal neovascularization (CNV) area (difference 0.233 mm2 [95% CI − 0.724 to 1.191]). Safety profiles and immunogenicity were similar between groups. Conclusion This study demonstrated therapeutic equivalence between Eyluxvi and Eylea in nAMD treatment, with comparable anatomical outcomes and safety profiles. These findings support the development of Eyluxvi as an aflibercept biosimilar, potentially increasing treatment accessibility for patients with nAMD. Trial Registration EudraCT Identifier 2021-004530-11.