By Fineline Cube 
China’s National Medical Products Administration (NMPA) has approved Bayer (ETR: BAYN) and Regeneron’s (NASDAQ: REGN) Eylea HD (aflibercept) injection 8 mg for the treatment of neovascular (wet) age-related macular degeneration (nAMD). This approval marks a significant advancement in the treatment options available for patients with this condition.
Treatment Regimen
Eylea HD is approved for an initial three-month regimen of monthly injections, followed by a treatment interval that can be extended to every four months based on physicians’ assessment of visual and/or anatomical outcomes. This flexible dosing schedule aims to provide sustained therapeutic benefits while minimizing the treatment burden on patients.
Clinical Trial Results
The NMPA approval is supported by positive results from the global Phase III PULSAR clinical trial. In this trial, Eylea HD demonstrated comparable visual acuity improvements to Eylea 2 mg (initially administered monthly for three months followed by fixed dosing every 8 weeks), while extending treatment intervals to 16 weeks or even 20 weeks. At 48 weeks, the Eylea HD treatment group also showed rapid and effective control of fluid accumulation. Additionally, the safety profile of Eylea HD was consistent with the established safety of Eylea 2 mg.-Fineline Info & Tech