EU clears Eylea 8 mg for retinal vein occlusion, expanding use of long-acting eye therapy
Treatment typically requires frequent injections directly into the eye—an ongoing burden for patients and health systems alike
Treatment typically requires frequent injections directly into the eye—an ongoing burden for patients and health systems alike
Under the agreement, AVT06 is licensed to enter the US market in the fourth quarter of 2026
The positive CHMP opinion is supported by results from the Phase III QUASAR trial
Health Canada’s approval was based on a comprehensive evaluation of analytical, nonclinical, and clinical data
Eylea 8 mg is the first and only anti-vascular endothelial growth factor (VEGF) treatment in the EU with treatment intervals of up to 6 months for both patients with nAMD and DME
Results from the open-label extension study of PHOTON demonstrate patients with diabetic macular edema (DME) randomized to Eylea 8 mg maintained visual and anatomic improvements at the end of three years
Yesafili, available in vial and prefilled syringe presentations (2 mg/0.05 mL), was the first biosimilar to Eylea approved by Health Canada
The approval is based on a comprehensive package of analytical, nonclinical, and clinical data
Subscribe To Our Newsletter & Stay Updated