FDA approved anti-VEGF treatment for all ocular complications of diabetes.
The FDA has ruled that all patients with ocular complications due to diabetes, with or without diabetic macular oedema (EMD), are eligible for treatment with Ranibizumab, with monthly intravitreal injections.
This is an extension of the treatment indication, as the same therapy had already been authorised for patients with EMD in February 2015.
The FDA decision is based on the results of the Diabetic Retinopathy Clinical Research Network Protocol S study, a study funded by the National Institute of Health (NIH), which compared the results of anti-VEGF treatment with panretinal laser photocoagulation in patients with diabetic retinopathy, with or without EMD.
The FDA measure was adopted by a designated procedure Priority Review Designationwhich is reserved for treatments recognised by the FDA as having significant potential to deliver significant improvements in safety and efficacy in the treatment of serious diseases.
In this case, the basis of the decision is certainly the awareness on the part of the US regulatory authorities of the serious health situation that the rapid growth in the incidence of diabetes and its complications is causing worldwide.
In Italy At present, anti-VEGFs (ranibizumab) are reimbursable for EMD patients only.
Dr. Carmelo Chines
Direttore responsabile
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