Novartis launches external review into safety of brolucizumab injection for treatment of wet age-related macular degeneration after concerns raised by American Society of Retinal Specialists (ASRS)

Since brolucizumab’s approval last Oct in US, ~46,000 injections have been administered and ASRS has received reports of 14 cases of vasculitis, of which 11 were designated occlusive retinal vasculitis. The FDA is aware of review, and other health authorities now being informed.

SPS commentary:

Brolucizumab was approved this month in the EU for the treatment of wet age-related macular degeneration.


Reuters Health