Bayer has announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) gave its nod to the submission of an application for regulatory approval of aflibercept 8 mg for the treatment of neovascular (wet) age-related macular degeneration(nAMD).

“Retinal disease is a significant health issue in China. For patients living with neovascular age-related macular degeneration, losing visual function substantially impacts their lives. It can result in loss of independence and an inability to conduct simple tasks such as reading, writing, and getting dressed. Although effective treatments are available, long-term treatment adherence can be difficult for these patients. Extended treatment intervals can address this important patient need by reducing the number of injections and alleviating the burden on patients,” said Member of the Executive Committee, Bayer’s Pharmaceuticals Division and Head of Research and Development, Dr. Christian Rommel.

At week 48 in the PULSAR clinical trial, aflibercept 8 mg, dosed with extended treatment intervals (every 12 or every 16 weeks) demonstrated comparable visual acuity to the standard of care Eylea (aflibercept 2 mg) with a fixed 8-week treatment interval, following three initial monthly doses. Aflibercept 8 mg showed unprecedented durability with 77 percent of nAMD patients randomised to the 16-week dosing arm achieving and maintaining 16-week treatment intervals with an average of only 5 injections through week 48.

Of those nAMD patients randomised to the aflibercept 8 mg 12-week dosing arm, 79 percent maintained their interval with an average of six injections through week 48. In addition, aflibercept 8 mg showed faster fluid control to the comparator Eylea (aflibercept 2 mg) through to week 48.