Bayer has announced that the National Medical Products Administration (NMPA) in China has accepted for review the application for aflibercept 8 mg (114.3 mg/ml solution for injection) to treat patients with visual impairment due to macular edema following Retinal Vein Occlusion (RVO) including central, branch, and hemiretinal vein occlusion.

Macular edema following RVO is a significant cause of visual impairment worldwide, including in China, and can result in sudden and rapid vision loss.

Dr. Christian Rommel, Global Head of Research and Development, Pharmaceuticals Division Bayer, said, “For patients with macular edema due to Retinal Vein Occlusion, treatment is essential to help preserve vision, but the usual monthly treatment frequency can be challenging to sustain. The QUASAR data show that aflibercept 8 mg could offer similar vision outcomes with fewer injections compared to monthly Eylea (aflibercept) 2 mg, which could make a meaningful difference in everyday care.”

The submission to the NMPA is supported by positive results from the global randomised clinical phase 3 trial QUASAR, which included patients from China. The study met its primary endpoint at week 36, demonstrating that patients receiving aflibercept 8 mg every 8 weeks (after 3 initial monthly injections) achieved comparable visual acuity gains and anatomical outcomes to those receiving the Eylea (aflibercept) 2 mg every 4 weeks.

In both treatment arms dosing intervals could be extended based on Dose Regimen Modification (DRM) criteria from week 32. Aflibercept 8 mg was well tolerated, and its safety profile was consistent with results from previous clinical trials.