Swiss giant Novartis’ (NYSE: NVS) Beovu (brolucizumab) received approval from China’s National Medical Products Administration (NMPA) for the treatment of macular edema in diabetes (DME). This marks a significant milestone for the ophthalmic therapy, which is the world’s first humanized single-chain antibody fragment (scFv) designed for ophthalmic use.
Beovu’s Advantages
Beovu stands out with its ultra-small molecular size (26 kDa), high-concentration formulation, and precise targeting of VEGF-A. These features enable superior fluid control efficacy and extended treatment intervals compared to previous-generation therapies. In clinical trials, Beovu demonstrated significant advantages in reducing intraretinal fluid (IRF) and subretinal fluid (SRF), requiring only 7 injections in the first year.
Clinical Trial Results
The KESTREL and KITE studies for brolucizumab in treatment-naïve DME patients met all primary efficacy endpoints, showing sustained visual acuity improvements through 100 weeks. This approval highlights Beovu’s potential to transform the treatment landscape for DME patients in China.-Fineline Info & Tech
