Aflibercept approval in Japan

Bayer has submitted an application to the Japanese Ministry of Health, Labour and Welfare (MHLW) seeking approval of aflibercept 8 mg (114.3 mg/ml solution for injection) for the treatment of patients with macular edema following retinal vein occlusion (RVO) including central, branch and hemiretinal vein occlusion. In Japan, this would be the third indication for aflibercept 8 mg supporting the blockbuster status of Eylea.

The submission to the MHLW is supported by favorable outcomes from the global randomized, double-masked, active-controlled phase III QUASAR study. The study was conducted in RVO patients from 27 countries, including Japan. This study achieved its primary endpoint at week 36, showing that patients treated with aflibercept 8 mg every 8 weeks (following 3 or 5 initial monthly doses) achieved visual acuity improvements that were non-inferior to patients receiving the current standard treatment, Eylea 2 mg (aflibercept 2 mg) every 4 weeks.

The QUASAR clinical study demonstrated that approximately 90% of patients on aflibercept 8 mg maintained their extended 8-week dosing intervals through 36 weeks, and almost 70% of patients (in the group with 3 initial monthly dosing) had a last assigned dosing interval of 12 weeks. Importantly, fluid reduction – an indicator of disease control – was similar with extended dosing intervals of aflibercept 8 mg compared with monthly doses of Eylea 2 mg. Additionally, aflibercept 8 mg was well tolerated, and its safety profile was consistent with previous clinical trials.

"Japan is an important market for Bayer in ophthalmology and today's submission marks a significant step towards enhancing patient care in retinal vein occlusion,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization, and Member of the Pharmaceuticals Leadership Team at Bayer. “Following approval in Japan, aflibercept 8 mg may offer extended treatment intervals for patients affected by macular edema due to retinal vein occlusion, thereby reducing the burden of frequent injections and clinic visits.”