The FDA has granted breakthrough therapy designation for Lucentis (ranibizumab; Genentech) for the treatment of diabetic retinopathy, according to a company statement.
A medicine may be designated as a breakthrough therapy by the FDA if it is intended to treat a serious or life-threatening disease or if preliminary clinical research suggests it will provide a significant improvement over existing therapies. The designation will expedite the development and review of Lucentis for diabetic retinopathy and reflects the unmet need for treatment options for diabetic retinopathy patients, according to Genentech.
In September, the FDA accepted the supplemental biologics license application for Lucentis and granted the medicine priority review for the treatment of diabetic retinopathy.
There are currently no approved ocular medications for diabetic retinopathy, which is estimated to affect 7.7 million Americans.
The FDA decision is based on the phase 3 RISE/RIDE trials, which showed meaningful improvements in diabetic retinopathy in a clinically significant proportion of patients treated with Lucentis at 2 years compared to patients treated with sham injections. Benefits of Lucentis treatment were maintained during year 3 of treatment. The safety in the RISE and RIDE phase 3 trials was consistent with previous studies.
The FDA’s confirmed action date for its biologics license application is February 6, 2015.