FDA Approves Brolucizumab for Wet Age-Related Macular Degeneration

Officials from the FDA have approved Novartis's brolucizumab injection (Beovu) for the treatment of wet age-related macular degeneration (AMD).

The approval was based on findings from the Phase III HAWK and HARRIER clinical trials. These trials were the first and only global head-to-head trials in patients with wet AMD that showed efficacy at week 48. In both trials, 30% of patients gained at least 15 letters at year one, and brolucizumab showed greater reduction in central subfield thickness as early as week 16.

Brolucizumab is the most clinically advanced humanized single-chain antibody fragment. This type of antibody is highly sought after due to their small size, enhanced tissue penetration, rapid clearance from systemic circulation, and drug delivery characteristics. It is engineered to deliver the highest concentration of the drug, providing more binding agents than other anti-VEGFs. Brolucizumab inhibits VEGF, suppressing future growth of abnormal blood vessels and fluid leakage into the retina.

Wet AMD is the leading cause of severe vision loss and legal blindness in people over age 65 years in many countries, impacting an estimated 20 million people worldwide. The condition occurs when abnormal blood vessels form underneath the area of the retina responsible for sharp, central vision. These blood vessels then leak fluid, which disrupts the normal retinal architecture and damaging the macula.

Reference

Novartis receives FDA approval for Beovu, offering wet AMD patients vision gains and greater fluid reductions vs aflibercept [news release]. Basel; Novartis Newsroom: October 8, 2019. https://www.novartis.com/news/media-releases/novartis-receives-fda-approval-beovu-offering-wet-amd-patients-vision-gains-and-greater-fluid-reductions-vs-aflibercept. Accessed October 8, 2019.