US regulators have assigned Genentech’s VEGF inhibitor Lucentis (ranibizumab) breakthrough therapy status as a treatment for diabetic retinopathy.
The drug has already being given a priority review in the US, and its breakthrough designation should help to further speed up its path through the regulatory process.
Essentially, the move signals the FDA’s belief that early clinical data for Lucentis suggest it will provide a significant improvement over existing therapies and could help to meet significant unmet medical need for treatment options.
There are currently no approved ocular medications for DR, which is estimated to affect around 7.7 million Americans. If approved, this will be the fourth indication for Lucentis, which is marketed outside of North America by Novartis, since 2006.