Roche granted priority review for diabetic retinopathy treatment

Roche has been awarded a priority review by the US Food and Drug Administration (FDA) for its Lucentis treatment for diabetic retinotherapy. 

The company's supplemental biologics license application was submitted in August, citing the unmet need for approved ocular medications for the condition, which affects 7.7 million Americans. It is the most common diabetic eye disease and the most significant cause of blindness in working-age citizens.

Priority review designation is granted by the FDA for medicines that would potentially provide significant improvements in the safety or efficacy of treatment, diagnosis or prevention of serious conditions when compared to what is currently available. The regulatory body's confirmed action date is February 6th 2015.

Sand Horning, chief medical officer and head of global product development at Roche, said: "We are committed to the treatment of serious eye diseases for patients with diabetes and pleased the FDA is moving forward in its consideration of Lucentis for diabetic retinopathy."

The submission has been based on the results of the treatment – also known by its chemical name ranibizumab – in the RISE and RIDE phase III trials.