EYLEA, which is formulated as an iso-osmotic solution, comprises portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1.
The approval was accorded based on the data from the Controlled Phase 3 Evaluation of Repeated intravitreal administration of VEGF Trap-Eye In Central retinal vein occlusion: Utility and Safety (COPERNICUS) and General Assessment Limiting Infiltration of Exudates in central retinal vein Occlusion with EYLEA (GALILEO) studies.
The randomized, multi-center, double-masked, sham-controlled studies have enrolled a total of 358 patients to assess the safety and efficacy of EYLEA injection.
The proportion of patients who gained at least 15 letters of best corrected visual acuity (BCVA) at 24 weeks compared to baseline as measured by ETDRS is the primary efficacy endpoint for both the studies.
The results demonstrated that the EYLEA 2 mg monthly group were superior to those for the sham control group for the primary endpoint.
Regeneron Laboratories president and Regeneron chief scientific officer George Yancopoulos said based upon the pivotal Phase 3 study results, EYLEA has been shown to significantly improve visual outcomes in a disease characterized by high VEGF levels.
"We thank the patients and clinical investigators who participated in our clinical studies, the FDA, and the Regeneron employees who helped make this day possible," Yancopoulos added.